ELUVIA™ H74939294701510Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 08714729876748), received between Jan 23, 2023 and Apr 30, 2026 — classified as 22 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (26 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 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 30, 2026Entrapment of Device; Deformation Due to Compressive Stress; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT THE STENT PARTIALLY DEPLOYED AND WAS ELONGATED. A 7X150, 130 CM ELUVIA WAS SELECTED FOR USE TO TREAT PERIPHERAL ARTERY DISEASE (PAD). DURING THE PROCEDURE, UPON DEPLOYMENT THE WHEEL BECAME PROBLEMATIC TO ROLL, CAUSING THE DEVICE TO BECOME STUCK ON THE WIRE. THE PHYSICIAN WAS ABLE TO PULL THE BLUE DEPLOYMENT ROD, AFTER WHICH THE ENTIRE STENT SUCCESSFULLY DEPLOYED. IT WAS ALSO NOTED THAT THE STENT WAS ELONGATED. THE PROCEDURE WAS COMPLETED WITH ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25048849 ↗
• InjuryFeb 17, 2026Deformation Due to Compressive Stress; Adverse Event Without Identified Device or Use Problem; Activation Failure

  IT WAS REPORTED THAT THE STENT WAS DAMAGED AND FAILED TO EXPAND, REQUIRING PLACEMENT OF ADDITIONAL STENT. THE 80-85% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MILDLY CALCIFIED PERIPHERAL ARTERY. A 7X150, 130 CM ELUVIA STENT WAS SELECTED FOR TREATMENT. THE DEVICE WAS PREPARED AND ATTEMPTED TO BE DEPLOYED AS NORMAL VIA CONTRALATERAL APPROACH. HOWEVER, DURING DEPLOYMENT, IT WAS OBSERVED THAT THE DISTAL ONE-THIRD OF THE STENT APPEARED TWISTED, RESULTING IN ONLY 75-80% (120 MM) OF THE STENT EXPANDING FULLY. THE PROCEDURE WAS COMPLETED AFTER PLACEMENT OF A SECOND ELUVIA STENT TO OPEN THE TWISTED AREA, FOLLOWED BY LINING BOTH STENTS WITH A LONG NON-BOSTON SCIENTIFIC STENT GRAFT. THERE WERE NO COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT FULLY RECOVERED FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24367752 ↗
• InjuryJan 14, 2026Deformation Due to Compressive Stress; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT STENT PARTIAL DEPLOYMENT AND DAMAGE OCCURRED, RESULTING IN ADDITIONAL INTERVENTION. THE 80 % STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MILDLY CALCIFIED SUPERFICIAL FEMORAL ARTERY. A 7X150, 130 CM ELUVIA WAS SELECTED FOR USE. DURING THE PROCEDURE, UPON STENT DEPLOYMENT USING THE TURN WHEEL, THE TURN WHEEL FAILED TO RETRACT THE DEPLOYMENT SHEATH HALFWAY THROUGH. THE STENT WAS DEPLOYED 50 CM OUT OF 150CM. THE PHYSICIAN HAD TO PULL THE DELIVERY SYSTEM, WHICH ELONGATED THE STENT APPROXIMATELY 100CM, REQUIRING ADDITIONAL INTERVENTION. THE DEVICE WAS PULLED OUT OF THE BODY, AND AN ADDITIONAL ANGIOPLASTY WAS PERFORMED. IT WAS NOTED THAT THE PATIENT EXPERIENCED DISCOMFORT AND PAIN; HOWEVER, THE PATIENT CONDITION WAS STABLE AFTER THE PROCEDURE.

  Patient problems: Discomfort; Pain

  MAUDE report 24068462 ↗
• MalfunctionDec 19, 2025Deformation Due to Compressive Stress; Activation, Positioning or Separation Problem; Deformation Due to Compressive Stress; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT THE STENT PARTIAL DEPLOYMENT OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED PERIPHERAL ARTERY VIA CONTRALATERAL FEMORAL APPROACH WITH THROUGH AND THROUGH ACCESS TO TIBIAL VESSEL. A 7X150,130CM ELUVIA STENT WAS SELECTED FOR USE. DURING THE PROCEDURE, THE STENT DEPLOYED ABOUT 100CM AND THEN FAILED. THE HANDLE BROKE APART TO REVEAL CATHETERS UNDERNEATH TO PIN AND PULL AND HAD TO STRAIGHTEN THE CATHETERS THAT HAD COILED UNDER THE THUMBWHEEL. CONSEQUENTLY, THE STENT BECAME STRETCHED OR ELONGATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23851304 ↗
• InjuryNov 21, 2025Fracture; Activation Failure; Fracture; Activation Failure

  IT WAS REPORTED THAT STENT FRACTURED OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED PERIPHERAL ARTERY. A 7X150, 130 CM ELUVIA STENT HAD BEEN PREVIOUSLY IMPLANTED ON (B)(6) 2025. THE PATIENT RETURNED TO THE HEALTHCARE FACILITY ON 27OCT2025. EXTENSIVE VESSEL PREP WAS PERFORMED INCLUDING 3 HOURS OF ANGIOSCULPT AND SHOCKWAVE IVL. AT THIS TIME IT WAS OBSERVED THAT THE IMPLANTED ELUVIA STENT HAD MULTIPLE FRACTURES WITH SEPARATION ALONG THE LENGTH OF THE STENT. THE STENT APPEARED ELONGATED BY APPROXIMATELY 5 CM FROM THE DISTAL PORTION AND WAS NOT FULLY EXPANDED. THE DAMAGED PORTION OF THE STENT REMAINED FULLY DEPLOYED IN THE VESSEL AND WAS NOT REMOVED, WITH ADDITIONAL INTERVENTION TO BE DISCUSSED. THE PATIENT WAS PLACED ON EKOS THERAPY AND WILL BE RE-EVALUATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Thrombosis/Thrombus

  MAUDE report 23621717 ↗
• InjuryOct 31, 2025Difficult or Delayed Positioning; Difficult or Delayed Activation; Deformation Due to Compressive Stress; Material Deformation; Difficult or Delayed Positioning; Difficult or Delayed Activation; Deformation Due to Compressive Stress; Material Deformation

  IT WAS REPORTED THAT AN ADDITIONAL STENT WAS USED DURING THE PROCEDURE. THE 70-90% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND SEVERELY CALCIFIED RIGHT SUPERFICIAL FEMORAL ARTERY AND LOWER EXTREMITY. AFTER PRE-DILATION, THE LESION WAS REDUCED TO 40-70% STENOSIS AND WAS NOTED TO BE MILDLY TORTUOUS WITH MILD TO MODERATE CALCIFICATION. A 7X150, 130 CM ELUVIA DRUG-ELUTING STENT WAS SELECTED FOR TREATMENT VIA CONTRALATERAL APPROACH. DURING DEPLOYMENT, THE THUMBWHEEL WAS USED UNTIL THE WHITE ARROW WAS VISIBLE, AND THE FORCE REQUIRED TO TURN THE THUMBWHEEL WAS NORMAL. THE WHITE ARROW WAS OBSERVED PRIOR TO USING THE PULL GRIP. HOWEVER, WHEN APPROXIMATELY 30 MM OF THE STENT HAD BEEN DEPLOYED, IT WAS NOTED THAT THE MIDDLE SHAFT DID NOT RETRACT TO PROXIMAL STENT MARKERS. ADDITIONAL MANIPULATION OF THE DELIVERY SYSTEM WAS REQUIRED TO FULLY DEPLOY THE STENT, INCLUDING ROTATION OF THE HANDLE, THUMBWHEEL AND PULL GRIP. THE STENT WAS EVENTUALLY IMPLANTED, BUT IT BECAME STRETCHED AND ELONGATED AT APPROXIMATELY 15 TO150CM. THE DELIVERY SYSTEM WAS REMOVED OVER THE WIRE, AND THE PROCEDURE WAS COMPLETED BY PLACING ADDITIONAL STENT TO LINE THE ELONGATED PORTION. THERE WERE NO PATIENT C

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23437072 ↗
• InjuryJul 7, 2025Activation, Positioning or Separation Problem; Material Deformation; Activation, Positioning or Separation Problem; Material Deformation

  IT WAS REPORTED THAT THE STENT PARTIALLY DEPLOYED, AND AN ADDITIONAL STENT WAS REQUIRED TO TREAT THE LESION. AN ELUVIA? WAS SELECTED FOR USE TO TREAT A SUPERFICIAL FEMORAL ARTERY (SFA) OCCLUSION. THE TARGET LESION WAS MILDLY CALCIFIED AND TORTUOUS AND WAS PRE-DILATED USING PLAIN OLD BALLOON ANGIOPLASTY (POBA). WHEN DEPLOYMENT WAS ATTEMPTED, ONLY 10-12 CM OF THE STENT DEPLOYED. THE HANDLE WAS DISASSEMBLED IN ORDER TO FULLY DEPLOY THE STENT. THE STENT STRETCHED BY AT LEAST 100 MM DURING THE DEPLOYMENT PROCESS. AN ADDITIONAL STENT WAS PLACED INSIDE THE FIRST STENT TO FULLY TREAT THE LESION. THE PROCEDURE WAS COMPLETED, AND THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22421772 ↗
• InjuryMay 19, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE STENT FRACTURED, REQUIRING AN ADDITIONAL DEVICE. THIS PATIENT WAS UNDERGOING THROMBOSIS TREATMENT OF THE SUPERFICIAL FEMORAL ARTERY (SFA). DURING A FOLLOW UP ANGIOGRAM TO CONFIRM THROMBUS LYSIS, A FRACTURE WAS NOTED IN A PREVIOUSLY PLACED 7X150, 130 CM ELUVIA STENT. THE APPROXIMATE LOCATION OF THE FRACTURE WAS IN THE DISTAL SFA GOING INTO THE PROXIMAL POPLITEAL ARTERY. ANOTHER ELUVIA STENT WAS PLACED OVER THE FRACTURED STENT. IT WAS NOTED THAT THE PATIENT WAS NON-COMPLIANT WITH ANTI-COAGULATION.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 22048448 ↗
• MalfunctionMar 20, 2025Entrapment of Device; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem; Entrapment of Device; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THIS STENT STARTED TO DEPLOY BEFORE THE YELLOW TAB WAS REMOVED. A 7MM X 150MM, 130CM ELUVIA SELF-EXPANDING STENT WAS SELECTED FOR TREATMENT OF STENOSIS IN THE SUPERFICIAL FEMORAL ARTERY. THE LESION WAS 70 PERCENT STENOSED WITH MODERATE TORTUOSITY AND MODERATE CALCIFICATION. WHILE ADVANCING THE STENT OVER THE WIRE, THE DELIVERY SYSTEM STOPPED TRACKING AND GOT STUCK ON THE WIRE. WHEN REMOVING THE WIRE AND DELIVERY SYSTEM, THE STENT WAS PARTIALLY STARTING TO DEPLOY EVEN THOUGH THE YELLOW TAB WAS NEVER REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER ELUVIA WITHOUT SEQUELAE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21652156 ↗
• InjuryJan 15, 2025Fracture; Activation, Positioning or Separation Problem; Material Deformation; Fracture; Activation, Positioning or Separation Problem; Material Deformation

  IT WAS REPORTED THAT STENT PARTIAL DEPLOYMENT AND FRACTURE OCCURRED. VASCULAR ACCESS WAS GAINED VIA CONTRALATERAL APPROACH. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATE TO SEVERELY CALCIFIED ARTERY IN THE RIGHT LEG. SEVERE TORTUOSITY WAS NOTED IN THE ILIAC ARTERY. A 7X150, 130 CM ELUVIA WAS SELECTED FOR USE. THE STENT WAS PREPPED AS NORMAL AND DELIVERED TO THE TREATMENT ZONE OVER A .014 NON-BOSTON SCIENTIFIC GUIDEWIRE. THE STENT WAS PREDILATED WITH A 6X150 STERLING BALLOON. DURING DEPLOYMENT, THE STENT WAS PARTIALLY DEPLOYED 80MM AND RESISTANCE WAS FELT WITH THE THUMB WHEEL. THE DEPLOYMENT SHAFT WAS USED TO DEPLOY THE STENT; HOWEVER, THE SHAFT SLID BACK. THE DEPLOYMENT HANDLE WAS OPENED AND AN ATTEMPT TO MANUALLY DEPLOY THE STENT BY PULLING THE INNER HYPOTUBE WAS PERFORMED. THE MID-SECTION OF THE STENT STRETCHED AND FRACTURED IN THE PROCESS OF DEPLOYMENT. KINKS WERE NOTED WITHIN THE DEPLOYMENT MECHANISM. THE GUIDEWIRE AND THE REMAINING DEVICE WERE REMOVED FROM THE PATIENT. THE RETAINED PORTION OF THE STENT WAS POST DILATED, AND THE DECISION WAS MADE TO LEAVE ANGIOGRAPHIC RESULTS ALONE. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT FULLY

  Patient problems: Foreign Body In Patient

  MAUDE report 21164043 ↗
• InjuryJan 10, 2025Fracture; Activation, Positioning or Separation Problem; Fracture; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT THE STENT PARTIALLY DEPLOYED AND FRACTURED, REQUIRING ADDITIONAL INTERVENTION. AN ELUVIA WAS SELECTED FOR USE. THE TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS SUPERFICIAL FEMORAL ARTERY. THE LESION WAS ACCESSED CONTRALATERALLY AND PREDILATED USING BALLOON ANGIOPLASTY. THE STENT WAS ADVANCED, AND DEPLOYMENT WAS ATTEMPTED. AFTER THE STENT WAS PARTIALLY DEPLOYED, THE THUMBWHEEL BECAME STUCK, AND THE STENT FRACTURED WITHIN THE PATIENT. THE PHYSICIAN UTILIZED A SNARE TO RETRIEVE THE FRACTURED PORTION OF THE STENT. THERE WERE NO REPORTED PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21124484 ↗
• InjuryNov 12, 2024Fracture; Activation, Positioning or Separation Problem; Fracture; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT THE STENT WAS DIFFICULT TO DEPLOY AND FRACTURED, REQUIRING INTERVENTION. A 7X150, 130 CM ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM WAS SELECTED FOR THE PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THE STENT HAD DIFFICULTY DEPLOYING. THEREFORE, THE PHYSICIAN ELECTED TO ATTEMPT REMOVING THE STENT; HOWEVER, A SMALL PIECE OF THE STENT BROKE OFF IN THE AREA OF THE LEG WHICH WAS BEING TREATED. AN ADDITIONAL STENT WAS IMPLANTED IN THE SAME AREA TO HOLD THE PIECE IN PLACE AND TO COMPLETE THE PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 20669247 ↗
• InjurySep 16, 2024Fracture; Activation, Positioning or Separation Problem; Material Deformation; Fracture; Activation, Positioning or Separation Problem; Material Deformation

  IT WAS REPORTED THAT STENT PARTIAL DEPLOYMENT, DAMAGE AND FRACTURE OCCURRED REQUIRING ADDITIONAL INTERVENTION. VASCULAR ACCESS WAS OBTAINED VIA ANTEGRADE APPROACH. THE TOTALLY OCCLUDED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MODERATELY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). A CUT DOWN WAS PERFORMED TO VISUALIZE THE FEMORAL ARTERY AND EVENTUALLY CANNULATE THE VESSEL FOR THE ENDO PORTION OF THE INTERVENTION. ANGIOGRAMS WERE OBTAINED SHOWING DIFFUSE DISEASE THROUGHOUT THE ENTIRE SFA WITH A SHORT CHRONIC TOTALLY OCCLUDED (CTO) PORTION. THE LESION WAS CROSSED AND PREDILATED WITH A RANGER BALLOON. THE POST BALLOON IMAGE SHOWED EXTRAVASATION. A 7X150, 130 CM ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM WAS SELECTED FOR USE. THE FIRST APPROXIMATELY 40-50MM OF THE STENT DEPLOYED WITH NO ISSUES, USING NORMAL FORCE. A POINT WAS REACHED WHERE THE DEPLOYMENT SYSTEM FAILED, EVEN BEFORE THE PULL GRIP PORTION. THE PHYSICIAN PULLED EVERYTHING IN AN ATTEMPT TO REMOVE IT ALL WHICH THEN STRETCHED THE ENTIRE STENT OUT 10-12CM AND THE STENT FRACTURED. THE PHYSICIAN ATTEMPTED TO PUT A WIRE AND CATHETER BACK DOWN TO PLACE A SECOND STENT INSIDE THE DAMAGED ONE, BUT NOTHING WOULD CROSS THE FR

  Patient problems: Foreign Body In Patient

  MAUDE report 20232882 ↗
• InjurySep 16, 2024Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT A STENT FRACTURE OCCURRED REQUIRING ADDITIONAL INTERVENTION. THE TARGET LESION WAS SEVERELY CALCIFIED AND MILDLY TORTUOUS. A 7X150, 130 CM ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM WAS SELECTED FOR USE. THE LESION WAS PREDILATED WITH A 6X200 RANGER DRUG COATED BALLOON (DCB). THE ELUVIA DEVICE WAS ADVANCED POST DCB; HOWEVER, RESISTANCE WAS FELT AND THE MID PORTION OF THE STENT FELT TIGHT. THE ELUVIA STENT FULLY EXPANDED AND DEPLOYED TO THE EXPECTED LENGTH. A 6X150 BALLOON WAS USED FOR POST DILATION. A FRACTURE OF THE ELUVIA STENT WAS NOTED POST DILATION. A COVERED STENT WAS PLACED INSIDE THE ELUVIA, LONG ENOUGH TO COVER THE FRACTURED PORTION OF THE ELUVIA STENT. THERE WERE NO PATIENT COMPLICATIONS, AND THE PATIENT IS DOING FINE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20231354 ↗
• MalfunctionSep 4, 2024Activation, Positioning or Separation Problem; Material Deformation; Positioning Problem; Activation, Positioning or Separation Problem; Material Deformation; Positioning Problem

  IT WAS REPORTED THAT PARTIAL DEPLOYMENT AND STENT DEFORMATION OCCURRED. VASCULAR ACCESS WAS GAINED VIA CONTRALATERAL APPROACH. THE TARGET LESION WAS LOCATED IN THE CHRONIC TOTAL OCCLUDED SUPERFICIAL FEMORAL ARTERY (SFA). A 7X150, 130 CM ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM WAS SELECTED FOR USE. DURING THE PROCEDURE, THE THUMBWHEEL WAS TURNED WITH HIGH FORCE AND THE STENT DEPLOYED 120MM. THERE WAS 3CM OF THE STENT THAT DID NOT DEPLOY. THE DEPLOYMENT HANDLE WAS OPENED AND THE BROWN HYPOTUBE WAS ATTEMPTED TO BE PULLED BACK. IT WAS NOTED THAT THE HYPOTUBE WAS BUNCHED UP INSIDE THE DEPLOYMENT HANDLE. THE WHOLE DEPLOYMENT SYSTEM WAS ATTEMPTED TO BE REMOVED WHICH ONLY STRETCHED OUT THE STENT 4CM. ULTIMATELY, IT WAS DISCOVERED THAT DEPLOYMENT OF THE STENT OCCURRED INSIDE THE GUIDE SHEATH. THE SHEATH WAS PULLED BACK ALLOWING THE STENT TO DEPLOY PARTIALLY IN THE INTENDED LOCATION. THE DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT MANUALLY. THE STENT WAS POST DILATED. THE PHYSICIAN STATED THE RO MARKER ON THE SHEATH WAS MISTAKEN AS THE STENT RO MARKER. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20139096 ↗
• InjuryAug 7, 2024Activation, Positioning or Separation Problem; Material Deformation; Activation, Positioning or Separation Problem; Material Deformation

  IT WAS REPORTED THAT THE STENT PARTIALLY DEPLOYED AND ELONGATED. A 7MM X 150MM, 130CM ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM WAS SELECTED FOR USE IN A VASCULAR INTERVENTION. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED AND MODERATELY TORTUOUS SUPERFICIAL FEMORAL ARTERY (SFA). ABOUT HALFWAY THROUGH STENT DEPLOYMENT, IT BECAME DIFFICULT TO TURN THE THUMBWHEEL, AND THE STENT WAS ELONGATING. AN ATTEMPT WAS MADE TO BREAK APART THE HANDLE, PIN THE BROWN INNER CATHETER, AND PULL BACK THE MIDDLE GRAY CATHETER TO DEPLOY. IT WAS STILL VERY DIFFICULT, WHICH CAUSE FURTHER STENT ELONGATION. THE NON-BOSTON SCIENTIFIC FILTER WIRE WAS EXCHANGED FOR A 0.035 WIRE. AT THIS POINT, THE INNER CATHETER WAS ABLE TO BE STRAIGHTENED, AND THE STENT DEPLOYED. THE ELONGATED PORTION OF THE STENT WAS RE-LINED WITH ANOTHER ELUVIA STENT OF THE SAME SIZE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19930374 ↗
• MalfunctionJul 8, 2024Activation, Positioning or Separation Problem; Material Deformation; Activation, Positioning or Separation Problem; Material Deformation

  IT WAS REPORTED THAT THE STENT PARTIALLY DEPLOYED. A 7X150, 130CM ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM WAS SELECTED TO COVER A DISSECTION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). PRIOR TO USE, ANGIOPLASTY AND ATHERECTOMY WAS PERFORMED IN THE SFA. THE ELUVIA WAS THEN INSERTED AND CROSSED EASILY. THE THUMBWHEEL WAS USED TO DEPLOY THE STENT, BUT IT SOUNDED LOUDER THAN NORMAL. AN ATTEMPT WAS MADE TO DEPLOY USING THE BLUE HANDLE, BUT THE BLUE HANDLE WOULD NOT ENGAGE OR MOVE AT ALL; IT WAS STUCK. THEREFORE, THE WHITE HANDLE WAS OPENED, AND THE SILVER COVERING WAS MANUALLY PULLED BACK OVER THE COPPER COVERING. THE STENT DEPLOYED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE STENT WAS APPROXIMATELY 50-60% DEPLOYED WHEN THE ISSUE OCCURRED. THE THUMBWHEEL WAS USED NORMALLY UNTIL IT REQUIRED GREATER FORCE AND STOPPED WORKING. THE STENT WAS STRETCHED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19697396 ↗
• MalfunctionMay 22, 2024Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT PARTIAL DEPLOYMENT OF THE STENT OCCURRED. VASCULAR ACCESS WAS GAINED VIA CONTRALATERAL APPROACH. THE SEVERELY CALCIFIED TARGET LESION WAS PREDILATED WITH A BALLOON. A 7X150, 130 CM ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM WAS SELECTED TO TREAT FOR PERIPHERAL ARTERY DISEASE (PAD). DURING DEPLOYMENT OF THE STENT, THE STENT WAS PARTIALLY DEPLOYED AND COULD NOT COMPLETE DEPLOYMENT. THE PHYSICIAN BROKE OPEN THE HANDLE OF THE DELIVERY SYSTEM TO MANUALLY DEPLOY THE REST OF THE STENT. THE STENT REMAINS IMPLANTED. THERE WERE NO PATIENT COMPLICATIONS, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THIS DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19370816 ↗
• InjuryMay 14, 2024Difficult to Remove; Activation, Positioning or Separation Problem; Material Deformation; Positioning Problem; Difficult to Remove; Activation, Positioning or Separation Problem; Material Deformation; Positioning Problem

  IT WAS REPORTED THAT THE DEVICE PARTIALLY DEPLOYED, STRETCHED, AND WAS DEPLOYED ACROSS A NON-TARGET VESSEL, REQUIRING AN ADDITIONAL DEVICE. THIS 7X150, 130 CM ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM WAS SELECTED FOR USE IN A LEFT LEG ANGIOGRAM AND ATHERECTOMY PROCEDURE. USING A CONTRALATERAL APPROACH, THE TARGET LESION WAS LOCATED IN THE 70% STENOSED, MILDLY CALCIFIED LEFT SUPERFICIAL FEMORAL ARTERY. WHILE ATTEMPTING TO PLACE THIS STENT, IT WAS NOTED THAT THE DEPLOYMENT WHEEL FELT STIFF, AND ELEVATED FORCE WAS REQUIRED TO TURN THE WHEEL. IT THEN BEGAN TO SPIN FREELY WHILE 100MM OF THE STENT WAS STILL CONSTRAINED. THE HANDLE WAS ALREADY FULLY EXTENDED; THEREFORE, THE DEPLOYMENT MECHANISM WAS OPENED TO MANUALLY DEPLOY THE STENT. HOWEVER, THE INNER MECHANISM WAS KINKED. WHILE ATTEMPTING TO RETRACT THE DEVICE, THE STENT BECAME ELONGATED AN ADDITIONAL 100 TO 150MM, AND WAS DEPLOYED ACROSS A NON-TARGET VESSEL. THE DEPLOYED STENT WAS POST DILATED AND ADDITIONAL STENTS WERE IMPLANTED INSIDE THE STENT. THE PROCEDURE WAS COMPLETED, AND THE PATIENT FULLY RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19311131 ↗
• MalfunctionApr 25, 2024Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT THE STENT PARTIALLY DEPLOYED. THIS 7X150, 130 CM ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM WAS SELECTED FOR USE IN AN ARTERIAL STENTING PROCEDURE. UPON DEPLOYMENT OF THE STENT, A POPPING SOUND WAS HEARD, THE THUMB WHEEL STOPPED ROLLING, AND ONLY APPROXIMATELY ONE THIRD OF THE STENT WAS ABLE TO BE DEPLOYED. THE STENT WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER ELUVIA STENT. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19182149 ↗
• InjuryFeb 16, 2024Fracture; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem; Fracture; Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE STENT PARTIALLY DEPLOYED AND FRACTURED. A 7X150 ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM WAS SELECTED FOR USE. A CONTRALATERAL APPROACH WAS USED TO ACCESS THE MID SUPERFICIAL FEMORAL ARTERY (SFA) THAT WAS SEVERELY DISEASED BUT NOT VERY TORTUOUS. A 6X150 STENT WAS PREVIOUSLY PLACED IN THE DISTAL SFA. THE DELIVERY SYSTEM WAS ADVANCED OVER A 0.014 GUIDEWIRE. AFTER DEPLOYING APPROXIMATELY 60MM OF THE 7X150 ELUVIA STENT USING THE THUMBWHEEL, THE DELIVERY SYSTEM FAILED. THE STENT WAS PARTIALLY DEPLOYED IN THE MID-SFA. THE PHYSICIAN THEN PULLED BACK THE BLUE HANDLE TO TRY AND UNSHEATH THE REMAINING 90MM TO NO AVAIL. THE PHYSICIAN SUBSEQUENTIALLY PULLED THE ENTIRE DEVICE BACK, HOPING THE STENT WOULD DEPLOY. IT WAS AT THAT POINT THE STENT FRACTURED INTO 2 PIECES. THE STENT WAS UNABLE TO BE RETRIEVED SINCE A WIRE WAS NO LONGER ABLE TO PASS DISTALLY. IT WAS AT THAT POINT THEY DECIDED TO CONVERT TO A BYPASS. THE BYPASS WAS COMPLETED SUCCESSFULLY, AND THE PATIENT IS RECOVERING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18726836 ↗
• InjuryJan 24, 2024Fracture; Activation, Positioning or Separation Problem; Material Deformation; Positioning Problem; Migration; Fracture; Activation, Positioning or Separation Problem; Material Deformation; Positioning Problem; Migration

  IT WAS REPORTED THAT THE STENT STRETCHED AND MIGRATED WITH DIFFICULT DEPLOYMENT. THIS ELUVIA DRUG-ELUTING VASCULAR STENT 7 MM X 150 MM X 130 CM WAS SELECTED FOR USE IN THE SUPERFICIAL FEMORAL ARTERY (SFA) AS TREATMENT FOR PERIPHERAL ARTERY DISEASE. THE LESION HAD MODERATE CALCIFICATION AND MILD TORTUOSITY. PRE-DILATION WAS PERFORMED WITH 4 MM X 120 MM COYOTE BALLOON, AND THE ELUVIA WAS ADVANCED OVER .014 THRUWAY GUIDEWIRE. ABOUT 50 MM INTO STENT DEPLOYMENT THE DELIVERY HANDLE AND THUMB WHEEL FAILED. THE PHYSICIAN ATTEMPTED TO DEPLOY BY PULLING ON THE DELIVERY HANDLE AND DISASSEMBLING THE STENT HANDLE. AFTER SEVERAL ATTEMPTS TO DELIVER, THE STENT BECAME ELONGATED AND MIGRATED FROM THE DISTAL SFA INTO THE PROXIMAL SFA AND COMMON FEMORAL ARTERY. THE STENT EVENTUALLY FRACTURED NEAR THE MIDDLE OF THE STENT, AND THE REMAINING PORTION WAS WITHDRAWN FROM THE PATIENT. A BALLOON WAS INFLATED TO BREAK THE STENT STRUTS, AND THE PHYSICIAN CONTINUED THE PROCEDURE BY DEPLOYING MORE STENTS SUCCESSFULLY. THE OTHER PORTION OF THE FRACTURED STENT WAS COVERED BY ANOTHER ELUVIA IN THE PROFUNDA ARTERY. THE PROCEDURE WAS CONSIDERED SUCCESSFUL, AND THE PATIENT WAS FULLY RECOVERED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18571388 ↗
• InjuryNov 29, 2023Fracture; Failure to Advance; Activation, Positioning or Separation Problem; Material Deformation; Fracture; Failure to Advance; Activation, Positioning or Separation Problem; Material Deformation

  IT WAS REPORTED THAT THE DEVICE PARTIALLY DEPLOYED, BECAME UNRAVELED AND THEN DETACHED, REQUIRING AN ADDITIONAL DEVICE. THIS 7X150, 130 CM ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM WAS SELECTED FOR USE IN A LEFT POPLITEAL AND SUPERFICIAL FEMORAL ARTERY STENT PROCEDURE. USING A CONTRALATERAL APPROACH, THE 100% STENOSED, SEVERELY TORTUOUS, SEVERELY CALCIFIED POPLITEAL AND DISTAL SFA LESIONS WERE PRE-DILATED WITH BALLOON ANGIOPLASTY. THE STENOSIS AFTER PRE-DILATION WAS 60%. THEN RESISTANCE WAS NOTED WHEN CROSSING THE OCCLUSION TO THE POPLITEAL LESION WITH THIS ELUVIA STENT. THE STENT WAS DEPLOYED USING THE THUMB WHEEL; HOWEVER, ONLY 2 CM OF THE STENT WAS DEPLOYED BEFORE A POPPING SOUND WAS HEARD. THE PULL GRIP WAS ALSO USED TO ATTEMPT DEPLOYMENT. THEN THE DEVICE HANDLE WAS OPENED TO DEPLOY THE STENT MANUALLY WITHOUT SUCCESS. AN ATTEMPT WAS MADE TO REMOVE THE STENT AND DEVICE AND UPON DOING SO, THE 2CM SECTION OF DEPLOYED STENT BECAME UNRAVELED AND DETACHED FROM THE DEVICE. ANOTHER STENT WAS IMPLANTED INSIDE THE SAME AREA. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: Foreign Body In Patient

  MAUDE report 18231456 ↗
• MalfunctionNov 9, 2023Entrapment of Device; Activation, Positioning or Separation Problem; Material Deformation; Entrapment of Device; Activation, Positioning or Separation Problem; Material Deformation

  IT WAS REPORTED THAT PARTIAL DEPLOYMENT OF STENT AND STENT ELONGATION OCCURRED. THE 80% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND SEVERELY CALCIFIED SUPERFICIAL FEMORAL ARTERY (SFA). A 7X150, 130 CM ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM WAS SELECTED FOR A SFA ATHERECTOMY, ANGIOPLASTY AND STENTING PROCEDURE. THE STENT WAS PLACED POST ATHERECTOMY OVER A .014 THRUWAY GUIDEWIRE. THE STENT WAS ONLY PARTIALLY DEPLOYED. THE PHYSICIAN HAD TO PULL THE ENTIRE DELIVERY SYSTEM BACK TO COMPLETELY DEPLOY THE STENT, AND IT WAS SIGNIFICANTLY ELONGATED. UPON REMOVAL OF THE DELIVERY CATHETER, IT WAS STUCK ON THE GUIDEWIRE. BOTH DELIVERY CATHETER AND GUIDEWIRE HAD TO BE REMOVED TOGETHER. THERE WERE NO PATIENT COMPLICATIONS, AND THE CASE WAS COMPLETED SATISFACTORILY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18103245 ↗
• MalfunctionOct 2, 2023Activation, Positioning or Separation Problem; Material Deformation; Activation, Positioning or Separation Problem; Material Deformation

  IT WAS REPORTED THAT THE STENT PARTIALLY DEPLOYED AND STRETCHED. A 7X150, 130 CM ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM WAS SELECTED FOR USE IN THE RIGHT LOWER EXTREMITY. THE PATIENT WAS BEING TREATED FOR PERIPHERAL ARTERY DISEASE (PAD). THIS WAS A CONTRALATERAL APPROACH WITH ACCESS THROUGH THE LEFT FEMORAL ARTERY USING A NON-BOSTON SCIENTIFIC 7F X 65 SHEATH. THE 100% STENOSED TARGET LESION WAS A CHRONIC TOTAL OCCLUSION (CTO) WITH SEVERE CALCIFICATION AND LOCATED IN THE MODERATELY TORTUOUS SUPERFICIAL FEMORAL ARTERY (SFA). THE ENTIRE SFA WAS BALLOONED WITH NON-BOSTON SCIENTIFIC 5MM AND 6MM DIAMETER BALLOONS. ADDITIONALLY, USING A NON-BOSTON SCIENTIFIC DEVICE, ATHERECTOMY WAS PERFORMED DUE TO ECCENTRIC LESIONS. NON-BOSTON SCIENTIFIC SHOCKWAVE THERAPY WAS ALSO PERFORMED THROUGHOUT THE SFA. A 7X150 ELUVIA WAS THEN PLACED IN THE DISTAL TO MID SFA OVER A 0.14 WIRE. A SECOND 7X150 ELUVIA WAS PLACED IN THE MID TO PROXIMAL SFA. DURING THIS DEPLOYMENT, THE THUMBWHEEL WAS USED TO PLACE THE STENT FOR THE FIRST 30MM WHILE LETTING THE STENT EXPAND FOR A FEW SECONDS TO ADHERE TO THE VESSEL WALL. THE BLUE HANDLE WAS THEN PULLED TO DEPLOY THE REST OF THE STENT, WHICH IS HOW THIS PHYSICIAN DEPLO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17856973 ↗