ELUVIA™ H74939294701210Recalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 08714729876731), received between May 14, 2019 and Nov 26, 2025 — classified as 37 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (29 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 58 reports, in the reporter's own words as published by the FDA.

• InjuryNov 26, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT OCCLUSION OCCURRED, REQUIRING MEDICAL INTERVENTION AND ADDITIONAL DEVICE. ON (B)(6) 2025, THE PATIENT WITH SEVERE PERIPHERAL VASCULAR DISEASE (PVD) AND CHRONIC LIMB-THREATENING ISCHEMIA (CLTI) PRESENTED WITH ULCERATION OF THE LEFT CALF. THE PATIENT REQUIRED AN INTERVENTION DUE TO SEVERE STENOSIS AND OCCLUSIONS IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA), ABOVE-KNEE POPLITEAL ARTERY, AND TIBIOPERONEAL TRUNK. THE PROCEDURE WAS PERFORMED UNDER MONITORED CONSCIOUS SEDATION (IV VERSED AND FENTANYL) WITH LOCAL ANESTHESIA USING 1% LIDOCAINE. THE RIGHT COMMON FEMORAL ARTERY (CFA) WAS ACCESSED RETROGRADELY UNDER ULTRASOUND GUIDANCE, AND A 5F SHEATH WAS PLACED. THE LEFT LOWER EXTREMITY WAS SELECTIVELY CATHETERIZED, INCLUDING THE LEFT COMMON FEMORAL, SUPERFICIAL FEMORAL, POPLITEAL, ANTERIOR TIBIAL, AND PERONEAL ARTERIES. ANGIOGRAPHIC FINDINGS REVEALED TOTAL OCCLUSION OF THE LEFT SFA AT THE ORIGIN, RECONSTITUTION DISTALLY AT HUNTER'S CANAL, WITH SEVERE DISEASE IN THE ABOVE-KNEE POPLITEAL ARTERY AND A DOMINANT POSTERIOR TIBIAL ARTERY FOR SINGLE-VESSEL RUNOFF. THE LEFT TIBIOPERONEAL TRUNK AND POSTERIOR TIBIAL ARTERY SHOWED SEVERE STENOSIS WITH CIRCUMFERENTIAL CALCIFICATION,

  Patient problems: Obstruction/Occlusion

  MAUDE report 23656740 ↗
• MalfunctionMay 19, 2025Break; Break

  IT WAS REPORTED THAT THE CATHETER BROKE. THIS 7X120, 130 CM ELUVIA SELF-EXPANDING STENT WAS SELECTED FOR USE IN A LEFT LOWER EXTREMITY ANGIOGRAM WITH INTERVENTION PROCEDURE. THE TARGET LESION WAS A LONG CHRONIC TOTAL OCCLUSION SEGMENT FROM THE PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA) TO THE MID POPLITEAL ARTERY. PRE-DILATION OF THE VESSEL WAS PERFORMED, THEN THIS STENT WAS USED WITH A NON-BOSTON SCIENTIFIC GUIDEWIRE. AFTER THE STENT WAS IMPLANTED, AS THE STENT CATHETER WAS BEING MOVED OUT OF THE BODY, A PIECE OF THE CATHETER BROKE OFF WHILE COMING OUT OF THE SHEATH. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22048452 ↗
• MalfunctionApr 1, 2025Activation, Positioning or Separation Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem; Activation, Positioning or Separation Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE STENT PARTIALLY DEPLOYED AND BECAME STRETCHED. THIS 7X120, 130 CM ELUVIA STENT WAS SELECTED FOR USE DURING AN ANGIOGRAM TO TREAT ATHEROSCLEROSIS OF THE SUPERFICIAL FEMORAL ARTERY. DURING THE PROCEDURE, USING A PEDAL APPROACH, THE STENT WAS 60% DEPLOYED WHEN THE THUMB WHEEL WOULD NO LONGER MOVE, AND PULL GRIP FELT LOOSE. THEREFORE, THE PHYSICIAN BROKE THE PULL HANDLE TO TRY AND DEPLOY THE STENT. INITIALLY, THE WIRE WOULD NOT DEPLOY THE STENT; HOWEVER, AFTER APPROXIMATELY 30 MINUTES, THE STENT WAS ABLE TO BE FULLY DEPLOYED WITH THE WIRE. THE STENT BECAME ELONGATED TO APPROXIMATELY 200CM AS A RESULT OF THIS. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21744723 ↗
• MalfunctionFeb 27, 2025Entrapment of Device; Activation, Positioning or Separation Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem; Entrapment of Device; Activation, Positioning or Separation Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE STENT WAS PARTIALLY DEPLOYED, AND UPON PULLING THE SYSTEM THE STENT FULLY DEPLOYED ALBEIT STRETCHED. THE TARGET LESION WAS IN THE SUPERFICIAL FEMORAL ARTERY; 85% STENOSED WITH MILD TORTUOSITY AND MODERATE CALCIFICATION. PRE-DILATATION WAS PERFORMED USING COYOTE BALLOON AND THEN TREATED WITH SHOCKWAVE TREATMENT. AFTER SHOCKWAVE TREATMENT, AN ANGIOGRAM WAS OBTAINED AND REVEALED THAT APPROXIMATELY 50% STENOSIS REMAINED AND THAT A STENT WAS NEEDED. THE 7MM X 120MM, 130CM ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM WAS SELECTED WITH NO APPARENT ISSUES UPON PREPPING AND INSERTION. THE STENT ADVANCED TO TARGET AREA WITH NO ISSUES OR RESISTANCE; HOWEVER, UPON DEPLOYMENT OF THE STENT ABOUT 1/3 OF THE STENT WAS DEPLOYED AND THE DEPLOYMENT WHEEL STARTED TO MAKE A DIFFERENT AUDIBLE NOISE AND THEN IT COMPLETELY LOCKED UP. WITH THE STENT NOT FULLY DEPLOYED, THE PHYSICIAN TRIED SEVERAL MEASURES TO GET THE REST DEPLOYED. THE THUMB WHEEL WAS FROZEN AND WOULD NOT TURN EITHER DIRECTION AND THE DEPLOYMENT HANDLE WAS ALSO FROZEN AND WOULD NOT MOVE. THE PHYSICIAN ALSO ATTEMPTED TO SLOWLY WALK BACK THE STENT CATHETER TO SEE IF THE STENT WOULD PULL OUT OF THE CATHETER, BUT WAS UNSUC

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21480088 ↗
• InjuryJan 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RESTENOSIS GUARANTEE PROGRAM. IT WAS REPORTED THAT IN-STENT RESTENOSIS OCCURRED, REQUIRING INTERVENTION. ON (B)(6)2024, THIS 7X120, 130 CM ELUVIA WAS SELECTED FOR USE IN AN ARTERIOGRAM WITH LEFT LEG REVASCULARIZATION PROCEDURE. DURING THE PROCEDURE, MULTIPLE WIRE AND CATHETER COMBINATIONS WERE USED TO CANNULATE THE OCCLUDED SUPERFICIAL FEMORAL ARTERY ORIGIN. AN UP AND OVER THROUGH AND THROUGH WIRE ACCESS APPROACH WAS OBTAINED FROM THE LEFT PEDAL TO THE RIGHT FEMORAL ACCESS SHEATHS. DUE TO LONG CHRONIC OCCLUSION WITH DENSE CALCIFICATION, A 2.5 MM ROTABLATOR DEVICE WAS USED TO PERFORM FEMORAL-POPLITEAL ATHERECTOMY. BALLOON ANGIOPLASTY WAS PERFORMED OF THE COMMON FEMORAL, SUPERFICIAL FEMORAL, AND POPLITEAL ARTERIES USING 6 MM PLAIN BALLOON. FOLLOW-UP ANGIOGRAM SHOWED RESTORED FLOW THROUGH THE FEMORAL AND POPLITEAL ARTERIES BUT WITH SEVERE RESIDUAL STENOSIS AND MULTIPLE AREAS OF FLOW-LIMITING DISSECTION. REPEAT BALLOON ANGIOPLASTY WAS PERFORMED WITH PROLONGED INFLATION BUT WITH PERSISTENT RESULTS. THIS WAS ADDRESSED WITH STENTING WITH FIVE ELUVIA STENTS WHICH ULTIMATELY REQUIRED EXTENSION FROM THE SUPERFICIAL FEMORAL ORIGIN DOWN TO THE POPLITEAL AT THE KNEE STENTS. BALLOON ANGIOPLASTY

  Patient problems: Pain; Restenosis; Thrombosis/Thrombus

  MAUDE report 21277620 ↗
• InjuryJan 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RESTENOSIS GUARANTEE PROGRAM IT WAS REPORTED THAT IN-STENT RESTENOSIS OCCURRED, REQUIRING INTERVENTION. ON (B)(6) 2024, THIS 7X120, 130 CM ELUVIA WAS SELECTED FOR USE IN AN ARTERIOGRAM WITH LEFT LEG REVASCULARIZATION PROCEDURE. DURING THE PROCEDURE, MULTIPLE WIRE AND CATHETER COMBINATIONS WERE USED TO CANNULATE THE OCCLUDED SUPERFICIAL FEMORAL ARTERY ORIGIN. AN UP AND OVER THROUGH AND THROUGH WIRE ACCESS APPROACH WAS OBTAINED FROM THE LEFT PEDAL TO THE RIGHT FEMORAL ACCESS SHEATHS. DUE TO LONG CHRONIC OCCLUSION WITH DENSE CALCIFICATION, A 2.5 MM ROTABLATOR DEVICE WAS USED TO PERFORM FEMORAL-POPLITEAL ATHERECTOMY. BALLOON ANGIOPLASTY WAS PERFORMED OF THE COMMON FEMORAL, SUPERFICIAL FEMORAL, AND POPLITEAL ARTERIES USING 6 MM PLAIN BALLOON. FOLLOW-UP ANGIOGRAM SHOWED RESTORED FLOW THROUGH THE FEMORAL AND POPLITEAL ARTERIES BUT WITH SEVERE RESIDUAL STENOSIS AND MULTIPLE AREAS OF FLOW-LIMITING DISSECTION. REPEAT BALLOON ANGIOPLASTY WAS PERFORMED WITH PROLONGED INFLATION BUT WITH PERSISTENT RESULTS. THIS WAS ADDRESSED WITH STENTING WITH FIVE ELUVIA STENTS WHICH ULTIMATELY REQUIRED EXTENSION FROM THE SUPERFICIAL FEMORAL ORIGIN DOWN TO THE POPLITEAL AT THE KNEE STENTS. BALLOON ANGIOPLASTY

  Patient problems: Pain; Restenosis; Thrombosis/Thrombus

  MAUDE report 21277611 ↗
• InjuryJan 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RESTENOSIS GUARANTEE PROGRAM. IT WAS REPORTED THAT IN-STENT RESTENOSIS OCCURRED, REQUIRING INTERVENTION. ON (B)(6) 2024, THIS 7X120, 130 CM ELUVIA WAS SELECTED FOR USE IN AN ARTERIOGRAM WITH LEFT LEG REVASCULARIZATION PROCEDURE. DURING THE PROCEDURE, MULTIPLE WIRE AND CATHETER COMBINATIONS WERE USED TO CANNULATE THE OCCLUDED SUPERFICIAL FEMORAL ARTERY ORIGIN. AN UP AND OVER THROUGH AND THROUGH WIRE ACCESS APPROACH WAS OBTAINED FROM THE LEFT PEDAL TO THE RIGHT FEMORAL ACCESS SHEATHS. DUE TO LONG CHRONIC OCCLUSION WITH DENSE CALCIFICATION, A 2.5 MM ROTABLATOR DEVICE WAS USED TO PERFORM FEMORAL-POPLITEAL ATHERECTOMY. BALLOON ANGIOPLASTY WAS PERFORMED OF THE COMMON FEMORAL, SUPERFICIAL FEMORAL, AND POPLITEAL ARTERIES USING 6 MM PLAIN BALLOON. FOLLOW-UP ANGIOGRAM SHOWED RESTORED FLOW THROUGH THE FEMORAL AND POPLITEAL ARTERIES BUT WITH SEVERE RESIDUAL STENOSIS AND MULTIPLE AREAS OF FLOW-LIMITING DISSECTION. REPEAT BALLOON ANGIOPLASTY WAS PERFORMED WITH PROLONGED INFLATION BUT WITH PERSISTENT RESULTS. THIS WAS ADDRESSED WITH STENTING WITH FIVE ELUVIA STENTS WHICH ULTIMATELY REQUIRED EXTENSION FROM THE SUPERFICIAL FEMORAL ORIGIN DOWN TO THE POPLITEAL AT THE KNEE STENTS. BALLOON ANGIOPLASTY

  Patient problems: Pain; Restenosis; Thrombosis/Thrombus

  MAUDE report 21277607 ↗
• InjuryDec 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ELEGANCE CLINICAL TRIAL. IT WAS REPORTED THAT THE SUBJECT SUFFERED RESTENOSIS OF THE TARGET LESION, REQUIRING HOSPITALIZATION AND ADDITIONAL INTERVENTION. THE SUBJECT UNDERWENT TREATMENT WITH THE ELUVIA DRUG ELUTING STENT ON (B)(6) 2024 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESION WAS IN THE LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY WITH 7 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 6 MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH 100 MM WITH 80% STENOSIS AND WAS CLASSIFIED AS TASC II D LESION. PRIOR TO THE TREATMENT OF TARGET LESION WITH THE STUDY DEVICE, PRE-DILATION WAS PERFORMED USING 6 MM X 100 MM STERLING PTA BALLOON. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION OF 7 MM X 120 MM ELUVIA DRUG ELUTING STENT STUDY DEVICE. FOLLOWING, POST-DILATION WAS PERFORMED USING 6 MM X 100 MM STERLING PTA BALLOON AND A NON-BOSTON SCIENTIFIC BALLOON. POST PROCEDURE, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 0%. ON (B)(6) 2024, THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL. ON (B)(6) 2024, SUBJECT VISITED THE HOSPITAL FOR 6-MONTH FOLLOW-UP ASSESSMENT, AND THE ABI AND PVR TRACINGS AT REST, SHOWED EVIDENCE OF MILD TO MODERATE PERIPHERAL ARTERIAL INSUFFICIENCY AND LACK

  Patient problems: Restenosis

  MAUDE report 20924299 ↗
• InjurySep 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IN-STENT OCCLUSION OCCURRED. ON (B)(6) 2024, THE PATIENT UNDERWENT INTRAVASCULAR ULTRASOUND EVALUATION OF LEFT ILIAC, COMMON FEMORAL, SUPERFICIAL FEMORAL, POPLITEAL, AND ANTERIOR TIBIAL ARTERIES FOR DIAGNOSTIC AND INTERVENTION PLANNING PURPOSES. LEFT SUPERFICIAL FEMORAL ARTERY WAS HEAVILY DISEASED WITH SCATTERED AREAS OF STENOSIS THROUGHOUT THE PROXIMAL THIGH AND CHRONIC TOTAL OCCLUSION IN THE MID-THIGH. POPLITEAL RECONSTITUTES AT THE PATELLA. SINGLE-VESSEL RUNOFF THROUGH THE ANTERIOR TIBIAL ARTERY WHICH IS DISEASED WITH MOST NOTABLE STENOSIS GREATER THAN 75% IN THE PROXIMAL CALF BUT PATENT DOWN TO THE FOOT. ATHERECTOMY WAS PERFORMED IN THE CHRONICALLY OCCLUDED LEFT SUPERFICIAL FEMORAL AND POPLITEAL USING A 1.5MM ROTABLATOR DEVICE. BALLOON ANGIOPLASTY WAS PERFORMED USING A 6MM BALLOON. THERE WAS A NOTABLE FLOW-LIMITING DISSECTION WITHIN THE SUPERFICIAL FEMORAL WHICH WAS STENTED USING 7X120MM, 7X120MM, AND 6X100MM ELUVIA DRUG-COATED SELF-EXPANDING STENTS. GOOD RESULT FROM REVASCULARIZATION WITH RESTORED VESSEL IN LINE FLOW TO THE FOOT THROUGH THE ANTERIOR TIBIAL ARTERY. THERE WAS RESIDUAL DISSECTION PROXIMAL AND DISTAL TO THE SUPERFICIAL FEMORAL STENTS BUT DID N

  Patient problems: Obstruction/Occlusion

  MAUDE report 20224607 ↗
• InjurySep 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IN-STENT OCCLUSION OCCURRED. ON (B)(6) 2024, THE PATIENT UNDERWENT INTRAVASCULAR ULTRASOUND EVALUATION OF LEFT ILIAC, COMMON FEMORAL, SUPERFICIAL FEMORAL, POPLITEAL, AND ANTERIOR TIBIAL ARTERIES FOR DIAGNOSTIC AND INTERVENTION PLANNING PURPOSES. LEFT SUPERFICIAL FEMORAL ARTERY WAS HEAVILY DISEASED WITH SCATTERED AREAS OF STENOSIS THROUGHOUT THE PROXIMAL THIGH AND CHRONIC TOTAL OCCLUSION IN THE MID-THIGH. POPLITEAL RECONSTITUTES AT THE PATELLA. SINGLE-VESSEL RUNOFF THROUGH THE ANTERIOR TIBIAL ARTERY WHICH IS DISEASED WITH MOST NOTABLE STENOSIS GREATER THAN 75% IN THE PROXIMAL CALF BUT PATENT DOWN TO THE FOOT. ATHERECTOMY WAS PERFORMED IN THE CHRONICALLY OCCLUDED LEFT SUPERFICIAL FEMORAL AND POPLITEAL USING A 1.5MM ROTABLATOR DEVICE. BALLOON ANGIOPLASTY WAS PERFORMED USING A 6MM BALLOON. THERE WAS A NOTABLE FLOW-LIMITING DISSECTION WITHIN THE SUPERFICIAL FEMORAL WHICH WAS STENTED USING 7X120MM, 7X120MM, AND 6X100MM ELUVIA DRUG-COATED SELF-EXPANDING STENTS. GOOD RESULT FROM REVASCULARIZATION WITH RESTORED VESSEL IN LINE FLOW TO THE FOOT THROUGH THE ANTERIOR TIBIAL ARTERY. THERE WAS RESIDUAL DISSECTION PROXIMAL AND DISTAL TO THE SUPERFICIAL FEMORAL STENTS BUT DID N

  Patient problems: Obstruction/Occlusion

  MAUDE report 20224596 ↗
• InjuryMay 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RESTENOSIS GUARANTEE PROGRAM IT WAS REPORTED THAT IN-STENT RESTENOSIS OCCURRED, REQUIRING INTERVENTION. ON (B)(6) 2023, THE PATIENT PRESENTED FOR SELECTIVE LEFT LOWER EXTREMITY ARTERIOGRAM, ATHERECTOMY, BALLOON ANGIOPLASTY AND STENTING OF AN OCCLUDED LEFT SUPERFICIAL FEMORAL ARTERY (SFA). ATHERECTOMY OF THE SFA WAS FIRST PERFORMED. THEN BALLOON ANGIOPLASTY WAS PERFORMED TO THE SFA WITH A 6 X 200 MM BALLOON UTILIZING TWO OVERLAPPING INFLATIONS, EACH HELD FOR THREE MINUTES. SUBSEQUENT IMAGING SHOWED SEVERAL AREAS OF SIGNIFICANT DISSECTION IN THE SFA; THEREFORE, A REPEAT FIVE-MINUTE BALLOON INFLATION WITH THE 8 MM BALLOON WAS PERFORMED. REPEAT IMAGING SHOWED RESOLUTION OF THE MOST DISTAL DISSECTION, BUT SIGNIFICANT RESIDUAL DISSECTION IN MID-SFA. THIS 7 X 120 MM ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM WAS THEREFORE DEPLOYED ON THE DISSECTION AND WAS POST-DILATED WITH A 6 MM BALLOON. FINAL IMAGING SHOWED AN EXCELLENT RESULT WITH NO SIGNIFICANT RESIDUAL STENOSIS AND NO SIGNIFICANT DISSECTIONS. A 6 FRENCH PERCUTANEOUS CLOSURE DEVICE WAS DEPLOYED IN THE RIGHT COMMON FEMORAL ARTERY WHICH RESULTED IN EXCELLENT HEMOSTASIS. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TAKEN TO THE RECOV

  Patient problems: Arteriosclerosis/ Atherosclerosis; Restenosis; Thrombosis/Thrombus

  MAUDE report 19352759 ↗
• MalfunctionOct 19, 2023Difficult or Delayed Positioning; Difficult to Remove; Adverse Event Without Identified Device or Use Problem; Difficult or Delayed Positioning; Difficult to Remove; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE STENT DELIVERY SYSTEM WAS DIFFICULT TO REMOVE AFTER STENT DEPLOYMENT. THIS 7X120, 130 CM ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM WAS SELECTED FOR USE IN A STENTING PROCEDURE. THE DIFFUSELY DISEASED, MILDLY CALCIFIED LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL ARTERY. A CONTRALATERAL APPROACH WAS USED. AFTER LASER ATHERECTOMY OF THE LESION, THE ELUVIA STENT WAS ATTEMPTED TO BE DEPLOYED OVER A NON-BOSTON SCIENTIFIC GUIDEWIRE. HOWEVER, THE THUMB WHEEL STOPPED WORKING AFTER THREE FOURTHS OF THE STENT WAS DEPLOYED IN THE LESION. THE PULL GRIP WAS USED, AND THE REMAINDER OF THE STENT WAS DEPLOYED. THEN THE PHYSICIAN REMOVED ONE FOURTH OF THE CATHETER INTO THE GUIDE SHEATH WHEN IT BECAME STUCK. THE PHYSICIAN CUT THE DEPLOYMENT HANDLE FROM THE CATHETER AND THE CATHETER AND GUIDEWIRE WERE SUCCESSFULLY REMOVED. THERE WERE NO PATIENT COMPLICATIONS. THERE IS NO PRODUCT AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17968085 ↗
• InjurySep 29, 2023Activation Failure; Activation Failure

  (B)(4). IT WAS REPORTED THAT THE SUBJECT EXPERIENCED STENT THROMBOSIS AND STENT UNDER EXPANSION DURING THE INDEX PROCEDURE. THE SUBJECT UNDERWENT TREATMENT WITH THE ELUVIA DRUG-ELUTING STENTS AND RANGER DRUG-COATED BALLOON ON (B)(6) 2023 AS A PART OF THE (B)(4) CLINICAL TRIAL. THE TARGET LESION (001) WAS IN THE LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA), LEFT MID SFA, LEFT DISTAL SFA, LEFT PROXIMAL POPLITEAL ARTERY, EXTENDING UP TO LEFT MID POPLITEAL ARTERY. THE TARGET LESION HAD A 5.5 MM DISTAL REFERENCE VESSEL DIAMETER WITH 70% STENOSIS AND WAS CLASSIFIED AS TASC II D LESION. PRIOR TO THE TREATMENT OF TARGET LESION WITH THE STUDY DEVICE, PRE-DILATION WAS PERFORMED BY USING 4 MM X 220 MM AND 6 MM X 120 MM STERLING OVER THE WIRE PTA BALLOON. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION USING STUDY DEVICES, PLACEMENT OF TWO 7 MM X 120 MM, ONE 7 MM X 60 MM, AND ONE 7 MM X 80 MM ELUVIA DRUG-ELUTING STENTS, FOLLOWED BY 6 MM X 120 MM RANGER DRUG-COATED BALLOON ANGIOPLASTY. FOLLOWING WHICH, POST-TREATMENT WAS PERFORMED WITH PLACEMENT OF A 7 MM X 250 MM NON-BOSTON SCIENTIFIC STENT AND BALLOON DILATION WAS PERFORMED BY USING A 6 MM X 60 MM NON-BOSTON SCIENTIFIC BALLOON, 7 MM X

  Patient problems: Thrombosis/Thrombus

  MAUDE report 17842992 ↗
• InjurySep 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  S2444 ELEGANCE. IT WAS REPORTED THAT THE SUBJECT EXPERIENCED STENT THROMBOSIS DURING THE INDEX PROCEDURE. THE SUBJECT UNDERWENT TREATMENT WITH THE ELUVIA DRUG-ELUTING STENTS AND RANGER DRUG-COATED BALLOON ON (B)(6) 2023 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESION (001) WAS IN THE LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA), LEFT MID SFA, LEFT DISTAL SFA, LEFT PROXIMAL POPLITEAL ARTERY, EXTENDING UP TO LEFT MID POPLITEAL ARTERY. THE TARGET LESION HAD A 5.5 MM DISTAL REFERENCE VESSEL DIAMETER WITH 70% STENOSIS AND WAS CLASSIFIED AS TASC II D LESION. PRIOR TO THE TREATMENT OF TARGET LESION WITH THE STUDY DEVICE, PRE-DILATION WAS PERFORMED BY USING 4 MM X 220 MM AND 6 MM X 120 MM STERLING OVER THE WIRE PTA BALLOON. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION USING STUDY DEVICES, PLACEMENT OF TWO 7 MM X 120 MM, ONE 7 MM X 60 MM, AND ONE 7 MM X 80 MM ELUVIA DRUG-ELUTING STENTS, FOLLOWED BY 6 MM X 120 MM RANGER DRUG-COATED BALLOON ANGIOPLASTY. FOLLOWING WHICH, POST-TREATMENT WAS PERFORMED WITH PLACEMENT OF A 7 MM X 250 MM NON-BOSTON SCIENTIFIC STENT AND BALLOON DILATION WAS PERFORMED BY USING A 6 MM X 60 MM NON-BOSTON SCIENTIFIC BALLOON, 7 MM X 80 MM STERLING O

  Patient problems: Thrombosis/Thrombus

  MAUDE report 17842985 ↗
• InjurySep 7, 2023Activation, Positioning or Separation Problem; Difficult to Advance; Material Deformation; Activation, Positioning or Separation Problem; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT THE STENT PARTIALLY DEPLOYED AND ELONGATED. A 7X120, 130 CM ELUVIA SELF-EXPANDING STENT WAS SELECTED FOR USE IN A SUPERFICIAL FEMORAL ARTERY (SFA) STENTING PROCEDURE. A CONTRALATERAL APPROACH WAS USED TO ACCESS THE TARGET LOCATION IN THE SFA THAT WAS DISSECTED, MODERATELY CALCIFIED, AND LOCATED IN MILDLY TORTUOUS ANATOMY. A 7X45 NON-BOSTON SCIENTIFIC GUIDING SHEATH, A .035X150 NON-BOSTON SCIENTIFIC SUPPORT CATHETER, AND .014X300 NON-BOSTON SCIENTIFIC GUIDEWIRE WERE PLACED IN THE PATIENT. THE PHYSICIAN PERFORMED 2.0 LASER ATHERECTOMY ON THE POPLITEAL AS WELL AS THE SFA. AFTERWARDS, A NON-BOSTON SCIENTIFIC SCORING BALLOON CATHETER WAS USED TO TREAT THE SFA AND POPLITEAL RESIDUAL DISEASE. AFTER ANGIOGRAPHY, DIFFUSE DISEASE WAS NOTED ALONG WITH DISSECTION, SO IT WAS DECIDED TO PLACE AN ELUVIA. THE VESSEL WAS PREDILATED WITH A 6X100 STERLING BALLOON CATHETER. THE PHYSICIAN PROCEEDED TO DEPLOY A 7X120 ELUVIA. RESISTANCE WAS FELT DURING ADVANCEMENT. THE PHYSICIAN NOTED THAT DEPLOYMENT FELT 'OFF' FROM THE BEGINNING. THE STENT WAS DEPLOYING ELONGATED AND NOT EVENLY. THE PHYSICIAN WAS UNABLE TO TRADITIONALLY DEPLOY THE STENT WITH THE THUMBWHEEL. HIGH FORCE WAS EXERTED ON

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17703712 ↗
• InjuryJul 28, 2023Difficult to Remove; Deformation Due to Compressive Stress; Activation, Positioning or Separation Problem; Difficult to Advance; Material Deformation; Difficult to Remove; Deformation Due to Compressive Stress; Activation, Positioning or Separation Problem; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT THE STENT PARTIALLY DEPLOYED, AND THE SHEATH AND STENT WERE UNABLE TO BE REMOVED FROM THE PATIENT. SURGICAL INTERVENTION WAS REQUIRED TO REMOVE THE DEVICE, AND PORTIONS OF THE STENT REMAINED IMPLANTED IN THE PATIENT. AN ELUVIA US, 7X120, 130 CM WAS SELECTED FOR USE IN THE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE TO TREAT CLAUDICATION. THE TARGET LESION WAS LOCATED WITHIN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) AND WAS HEAVILY CALCIFIED WITH A SHORT SEGMENT OF CHRONIC TOTAL OCCLUSION (CTO). THE PHYSICIAN ATTEMPTED TO CROSS THE CTO FROM CONTRALATERAL GROIN WITH UP AND OVER ACCESS USING A 6F NON-BOSTON SCIENTIFIC SHEATH, BUT WAS UNABLE TO DO SO. ACCESS TO THE TARGET LESION WAS GAINED VIA THE TIBIAL VESSEL AND CROSSED FROM BELOW USING A NON-BOSTON SCIENTIFIC GUIDEWIRE. THE WIRE WAS THEN SNARED AND PULLED THROUGH THE GROIN ACCESS IN ORDER TO PERFORM INTERVENTION FROM THE LEFT GROIN. THE VESSEL WAS PREDILATED USING MULTIPLE INFLATIONS OF A NON-BOSTON SCIENTIFIC BALLOON. PTA OF THE RIGHT PROXIMAL POPLITEAL THROUGH THE PROXIMAL SFA WAS PERFORMED. THE PHYSICIAN THEN STENTED THE PROXIMAL POPLITEAL/DISTAL SFA WITH A 7X150 ELUVIA WITH NO ISSUES. THEN HE PLA

  Patient problems: Foreign Body In Patient

  MAUDE report 17413912 ↗
• InjuryMay 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS TOTAL OCCLUSION OF THE PREVIOUSLY STENTED LESION WHICH REQUIRED INTERVENTION. THIS 7X120, 130 CM ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM WAS PREVIOUSLY PLACED DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY PROCEDURE. THE PATIENT RECEIVED STENTS IN THE LEFT EXTERNAL ILIAC, RIGHT SUPERFICIAL FEMORAL, AND POPLITEAL ARTERIES. THE PATIENT LATER PRESENTED WITH RIGHT LOWER EXTREMITY INCAPACITATING CLAUDICATION. AN ABDOMINAL AORTOGRAM, BILATERAL LOWER EXTREMITY ARTERIOGRAM, SELECTIVE RIGHT LOWER EXTREMITY ARTERIOGRAM FROM THE COMMON FEMORAL ARTERY, AND ADDITIONAL SELECTIVE RIGHT LOWER EXTREMITY ARTERIOGRAM FROM THE POPLITEAL ARTERY WERE PERFORMED. THESE SHOWED TOTAL OCCLUSION OF THE SUPERFICIAL FEMORAL ARTERY (SFA), AND ABOVE-KNEE POPLITEAL ARTERY WITH HIGH GRADE OBSTRUCTION OF THE PROFUNDA FEMORIS. THEREFORE, ATHERECTOMY WITH ANGIOPLASTY OF THE RIGHT SUPERFICIAL FEMORAL AND POPLITEAL ARTERIES, AND BALLOON ANGIOPLASTY OF THE RIGHT PROFUNDA FEMORIS WERE PERFORMED. DIAGNOSTIC FILMS AFTERWARD SHOWED EVIDENCE OF VASOSPASM WHICH RESOLVED AFTER ADMINISTRATION OF INTRA-ARTERIAL NITROGLYCERIN. THERE WERE NO OTHER PATIENT COMPLICATIONS.

  Patient problems: Arteriosclerosis/ Atherosclerosis; Obstruction/Occlusion; Restenosis; Vasoconstriction

  MAUDE report 17007685 ↗
• InjuryApr 12, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT THE DEPLOYED STENT MEASUREMENTS DID NOT MATCH THE DEVICE LABELING, AND AN ADDITIONAL DEVICE HAD TO BE DEPLOYED TO ADEQUATELY TREAT THE PATIENT. AN ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM, 7X120, 130 CM WAS SELECTED FOR USE IN THE ARTERIAL STENTING PROCEDURE. THE PATIENT HAD PREVIOUS STENTS PLACED, BUT THERE WERE GAPS IN THEIR COVERAGE OF THE VESSEL AND NEW STENOSIS HAD DEVELOPED IN THOSE GAPS. THE ELUVIA 7X120 WAS SELECTED TO USE THE ENTIRE STENT LENGTH TO COVER THE PREVIOUSLY IMPLANTED STENTS AND TO COVER THE GAPS IN COVERAGE. WHEN LOADING THE ELUVIA ON THE WIRE, THE PHYSICIAN ASSESSED THE MARKERS WERE EXACTLY THE LENGTH APPROPRIATE FOR THE PROCEDURE. DEPLOYMENT BEGAN, AND THE PHYSICIAN NOTED THAT THE MARKERS ON THE DELIVERY SYSTEM APPEARED TO BE MOVING AND NOT MATCHING UP WITH THE CORRECT LENGTH OF THE STENT. ONCE THE STENT WAS FULLY DEPLOYED, THE STENT ONLY MEASURED APPROXIMATELY 60 MM IN LENGTH ON FLUOROSCOPY. THE CUSTOMER HYPOTHESIZED THAT EITHER THE BOX WAS MISLABELED, OR THE INCORRECT STENT LENGTH WAS LOADED ONTO THE INCORRECT STENT DELIVERY SYSTEM. AN ADDITIONAL NON-BSC STENT WAS NEEDED TO FINISH COVERING THE TARGET LOCATION. THE PROCEDURE WAS COMPLET

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16728214 ↗
• MalfunctionApr 4, 2023Activation, Positioning or Separation Problem; Material Integrity Problem; Migration; Activation, Positioning or Separation Problem; Material Integrity Problem; Migration

  IT WAS REPORTED THAT THE STENT PARTIALLY DEPLOYED AND WAS POTENTIALLY STRETCHED AS A RESULT. ADDITIONALLY, THE STENT MIGRATED POST-DEPLOYMENT. AN ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM WAS SELECTED FOR USE IN THE SUPERFICIAL FEMORAL ARTERY (SFA) TO TREAT THE PATIENT'S PERIPHERAL ARTERY DISEASE. THE ELUVIA WAS ADVANCED TO THE TARGET LESION OVER AN UNKNOWN 0.014 IN. GUIDEWIRE VIA A CONTRALATERAL APPROACH AND DEPLOYMENT BEGAN. ONCE THE STENT WAS DEPLOYED APPROXIMATELY HALF-WAY, THE THUMBWHEEL BECAME LOOSE, AND WAS JUST SPINNING, NOT ALLOWING THE STENT TO FULLY DEPLOY. THE DELIVERY SYSTEM HANDLE WAS DISMANTLED, AND DEPLOYMENT WAS COMPLETED USING A PIN-PULL METHOD WITH THE INNERMOST CATHETER AND THE MIDDLE CATHETER. THIS ALLOWED THE STENT TO BE DEPLOYED WITH INTEGRITY. HOWEVER, THE STENT APPEARED TO HAVE MIGRATED PROXIMALLY AND MAY HAVE COVERED THE ORIGIN OF THE PROFUNDA. THE STENT MAY HAVE BEEN STRETCHED OR ELONGATED AS A RESULT OF THE PARTIAL DEPLOYMENT. THE PROCEDURE WAS COMPLETED, AND THERE WERE NO FURTHER CONSEQUENCES REPORTED FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16679163 ↗
• InjuryMar 9, 2023Fracture; Activation, Positioning or Separation Problem; Material Deformation; Fracture; Activation, Positioning or Separation Problem; Material Deformation

  IT WAS REPORTED THAT THERE WAS AN UNRETRIEVED DEVICE FRAGMENT. A 7X120 ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM WAS SELECTED FOR USE IN A LEG INTERVENTION. DURING THE PROCEDURE, HALF OF THE STENT WAS DEPLOYED WHEN THE THUMBWHEEL KEPT SPINNING WITHOUT DEPLOYING THE REST OF THE STENT. ULTIMATELY THE STENT WAS ABLE TO BE DEPLOYED, ALBEIT DEFORMED. AFTER A CONTRAST RUN, IT WAS OBSERVED THAT PART OF THE INTERNAL STENT SYSTEM WENT DOWNSTREAM AND CREATED NO FLOW. THE FRAGMENT COULD NOT BE SNARED BECAUSE IT COULD NOT BE SEEN UNDER FLUOROSCOPY. THE FRAGMENT WAS INSTEAD PUSHED INTO A PERONEAL BRANCH. NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT IS EXPECTED TO FULLY RECOVER.

  Patient problems: Foreign Body In Patient

  MAUDE report 16517636 ↗
• MalfunctionDec 9, 2022Activation, Positioning or Separation Problem; Material Deformation; Activation, Positioning or Separation Problem; Material Deformation

  IT WAS REPORTED THAT THE STENT WAS PARTIALLY DEPLOYED, AND WAS STRETCHED AS A RESULT. THE ELUVIA WAS SELECTED FOR USE IN THE PERIPHERAL ANGIOGRAM PROCEDURE TO TREAT PERIPHERAL ARTERY DISEASE (PAD). THE TARGET LESION WITHIN THE PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA) WAS REPORTEDLY 100 PERCENT STENOSED. THE PATIENT UNDERWENT LASER ATHERECTOMY AND PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WITH A STERLING BALLOON. THE ELUVIA WAS BEING DEPLOYED AT THE PROXIMAL SFA, WHERE ONE HALF OF THE STENT WAS REALIGNING A PREVIOUSLY PLACED STENT OF UNKNOWN ORIGIN. DURING ELUVIA DEPLOYMENT, APPROXIMATELY 10MM OF THE STENT WOULD NOT UNSHEATHE FROM THE CATHETER. THE PHYSICIAN PULLED THE PULL GRIP SLOWLY AND EVENLY, BUT THE ISSUE PERSISTED. THE PHYSICIAN PULLED BACK ON THE HANDLE OF THE STENT, AND THE STENT COULD BE SEEN STRETCHING ON THE ANGIOGRAM. THE OUTER BLUE STABILIZING SHAFT WAS PULLED BACK AND THE DISTAL END OF THE STENT WAS UNSHEATHED. AS A RESULT OF TROUBLESHOOTING, THE DISTAL END OF THE STENT WAS STRETCHED INTO THE COMMON FEMORAL BY AN ADDITIONAL 10-20CM. POST PTA OF THE STENT WAS COMPLETED, AND THERE WERE NO DISSECTIONS OR FLOW DISTURBANCES. THE PATIENT HAD SIGNIFICANTLY IMPROVED FLOW C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15951555 ↗
• InjuryDec 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED RIGHT LOWER EXTREMITY CRITICAL LIMB ISCHEMIA, RESULTING IN RIGHT LEG ABOVE THE KNEE AMPUTATION 216 DAYS POST INDEX PROCEDURE. ON (B)(6) 2022, THE PATIENT UNDERWENT TREATMENT FOR PERIPHERAL ARTERY DISEASE (PAD) WITH TWO ELUVIA DRUG-ELUTING STENTS AND A RANGER DRUG COATED BALLOON AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESION WAS LOCATED IN THE RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) EXTENDING INTO THE RIGHT PROXIMAL POPLITEAL ARTERY. THE TARGET LESION HAD A PROXIMAL REFERENCE VESSEL DIAMETER OF 6.0 MM AND DISTAL REFERENCE VESSEL DIAMETER OF 6.0 MM WITH LESION LENGTH OF 400 MM. THE VESSEL WAS 100% STENOSED AND WAS CLASSIFIED AS TASC II B LESION. PRIOR TO TARGET LESION TREATMENT WITH THE STUDY DEVICES, PRE-DILATATION WAS PERFORMED USING A 5 MM X 200 MM NON-BSC BALLOON AND A 5 MM X 80 MM NON-BSC BALLOON AND PLACEMENT OF A 7 MM X 150 MM NON-BSC METAL STENT. TREATMENT OF THE TARGET LESION WAS PERFORMED BY PLACEMENT USING STUDY DEVICES OF SIZE 5 MM X 200 MM RANGER DRUG COATED BALLOON AND TWO ELUVIA DRUG-ELUTING STENTS OF SIZE 7 MM X 120 MM. FOLLOWING STENT PLACEMENT, POST-DILATATION WAS PERFORMED USING A 5 MM X 80 MM NON-BSC

  Patient problems: Ischemia; Necrosis; Pain; Unspecified Vascular Problem

  MAUDE report 15904745 ↗
• InjuryDec 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED RIGHT LOWER EXTREMITY CRITICAL LIMB ISCHEMIA, RESULTING IN RIGHT LEG ABOVE THE KNEE AMPUTATION 216 DAYS POST INDEX PROCEDURE. ON (B)(6) 2022, THE PATIENT UNDERWENT TREATMENT FOR PERIPHERAL ARTERY DISEASE (PAD) WITH TWO ELUVIA DRUG-ELUTING STENTS AND A RANGER DRUG COATED BALLOON AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESION WAS LOCATED IN THE RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) EXTENDING INTO THE RIGHT PROXIMAL POPLITEAL ARTERY. THE TARGET LESION HAD A PROXIMAL REFERENCE VESSEL DIAMETER OF 6.0 MM AND DISTAL REFERENCE VESSEL DIAMETER OF 6.0 MM WITH LESION LENGTH OF 400 MM. THE VESSEL WAS 100% STENOSED AND WAS CLASSIFIED AS TASC II B LESION. PRIOR TO TARGET LESION TREATMENT WITH THE STUDY DEVICES, PRE-DILATATION WAS PERFORMED USING A 5 MM X 200 MM NON-BSC BALLOON AND A 5 MM X 80 MM NON-BSC BALLOON AND PLACEMENT OF A 7 MM X 150 MM NON-BSC METAL STENT. TREATMENT OF THE TARGET LESION WAS PERFORMED BY PLACEMENT USING STUDY DEVICES OF SIZE 5 MM X 200 MM RANGER DRUG COATED BALLOON AND TWO ELUVIA DRUG-ELUTING STENTS OF SIZE 7 MM X 120 MM. FOLLOWING STENT PLACEMENT, POST-DILATATION WAS PERFORMED USING A 5 MM X 80 MM NON-BSC

  Patient problems: Ischemia; Necrosis; Pain; Unspecified Vascular Problem

  MAUDE report 15904652 ↗
• InjuryNov 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ELEGANCE STUDY: IT WAS REPORTED THAT AN OCCLUSION OCCURRED, REQUIRING HOSPITALIZATION AND BYPASS SURGERY. THE SUBJECT UNDERWENT TREATMENT WITH THE ELUVIA DRUG-ELUTING STENT AND RANGER DRUG COATED BALLOON ON (B)(6) 2021 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESION WAS IN THE LEFT MID SUPERFICIAL FEMORAL ARTERY WITH PROXIMAL REFERENCE VESSEL DIAMETER 6.0 MM AND DISTAL REFERENCE VESSEL DIAMETER OF 6.0 MM WITH LESION LENGTH OF 380 MM AND 100% STENOSIS. PRIOR TO TARGET LESION TREATMENT WITH STUDY DEVICE, PRE-DILATATION WAS PERFORMED USING 5 MM X 300 MM NON-BOSTON SCIENTIFIC SCORING BALLOON AND 3 MM X 200 MM NON-BOSTON SCIENTIFIC PTA BALLOON. TREATMENT OF TARGET LESION WAS PERFORMED WITH TWO STUDY DEVICES, 6 MM X 200 MM AND 5 MM X 200 MM RANGER DRUG COATED BALLOONS AND 7 MM X 120 MM, ELUVIA DRUG ELUTING STENT. FOLLOWING POST DILATATION WAS PERFORMED WITH 6 MM X 80 MM NON-BOSTON SCIENTIFIC PTA BALLOON, AND THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 10%. ON (B)(6) 2021, THE SUBJECT WAS DISCHARGED FROM THE HOSPITAL ON DUAL ANTIPLATELET THERAPY. ON (B)(6) 2022, THE SUBJECT WAS NOTED WITH THE SYMPTOMS RELATED TO OCCLUDED SFA. ON (B)(6)2022, THE SUBJECT WAS HOSPITALIZED FOR FUR

  Patient problems: Ischemia; Obstruction/Occlusion; Pain

  MAUDE report 15811365 ↗
• MalfunctionNov 8, 2022Activation, Positioning or Separation Problem; Material Deformation; Activation, Positioning or Separation Problem; Material Deformation

  IT WAS REPORTED THAT PARTIAL DEPLOYMENT OCCURRED RESULTING IN A STRETCHED STENT. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). TWO 7X120, 130 CM ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEMS WERE SELECTED FOR USE. BALLOON ANGIOPLASTY WAS PERFORMED IN THE LONG SEGMENT SFA. SOME RECOILS AND DISSECTIONS WERE NOTICED, SO IT WAS DECIDED TO STENT WITH ELUVIA STENT. DEPLOYMENT WAS ATTEMPTED WITH THE FIRST ELUVIA STENT USING THE THUMBWHEEL. THE THUMB WHEEL WOULD NO LONGER WORK TO FINISH DEPLOYMENT LEADING TO PARTIAL DEPLOYMENT AND THE LAST HALF CENTIMETER GETTING STUCK IN THE DEPLOYMENT SYSTEM. IN ORDER TO GET THE LAST HALF CENTIMETER OF THE STENT OUT OF THE DEPLOYMENT SYSTEM, THE PHYSICIAN HAD TO PULL THE DELIVERY SYSTEM WITH THE STENT STILL ATTACHED RESULTING IN SEVERE ELONGATION AND STRETCHING OF THE STENT. THE SAME ISSUE WAS ENCOUNTERED WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE SECOND STENT. THE PATIENT FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15751819 ↗