BioMimics 3D Vascular Stent System 144700-19Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 05391526850527), received between Aug 10, 2021 and Apr 25, 2025 — classified as 28 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (12 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 44 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 25, 2025Fracture; Material Deformation; Insufficient Device Problem Information; Fracture; Material Deformation; Insufficient Device Problem Information

  ON MARCH 27, 2025, A VERYAN SALES SPECIALIST RECEIVED INFORMATION THAT REPORTED A FRACTURE OF A 7 X 150 MM BIOMIMICS 3D (BM3D) STENT WHICH WAS ORIGINALLY PLACED IN (B)(6) 2024.

  Patient problems: Insufficient Information

  MAUDE report 21908946 ↗
• MalfunctionFeb 12, 2025Stretched; Activation Failure; Stretched; Activation Failure

  ON (B)(6) 2025, A PHYSICIAN WAS USING A BIOMIMICS 3D (BM3D) 7.0 X 150MM DEVICE TO TREAT A PATIENT. IT WAS REPORTED THAT THE PHYSICIAN WAS UNABLE TO COMPLETE DEPLOYMENT OF STENT; IT APPEARS THE SYSTEM STRETCHED AND BECAME DETACHED. THE PATIENT ANATOMY WAS DESCRIBED AS CONTAINING CALCIFICATION IN THE SFA AND A MODERATE TORTUOSITY. A CONTRALATERAL APPROACH WAS TAKEN, WITH THE USE OF AN.018" GUIDEWIRE. THE PHYSICIAN PERFORMED VESSEL PREPARATION VIA LASER ATHERECTOMY USING A PHILLIPS DEVICE. THEN, HAVING BEEN FLUSHED IN ACCORDANCE WITH IFU-3 VERSION 4.0, THE BIOMIMICS 3D DEVICE WAS INTRODUCED TO THE PATIENT AND ADVANCED TO THE TARGET SITE. WHEN IN POSITION, THE TUOHY BORST VALVE WAS LOOSENED, EXCESS SLACK WAS REMOVED, AND DEPLOYMENT OF THE STENT WAS INITIATED WHILE HOLDING THE PROXIMAL PIN LUER IN A FIXED POSITION. FEEDBACK INDICATED THAT THE PHYSICIAN EXPERIENCED RESISTANCE UPON THE INITIATION OF DEPLOYMENT. THE PHYSICIAN CONTINUED THE DEPLOYMENT, WHICH RESULTED IN THE RELEASE OF A PORTION OF THE BIOMIMICS 3D STENT. IT WAS REPORTED THAT A SEVERE ELONGATION OF THE OUTER BRAID OCCURRED DURING THE DEPLOYMENT ATTEMPT, AND THAT THE CONTINUED DEPLOYMENT ATTEMPT ULTIMATELY RESULTED IN THE SEP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21364494 ↗
• InjurySep 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS RELATED TO MDR NUMBER 3011632150-2024-00046. THIS PATIENT WAS ENROLLED IN THE MIMICS 3D USA POST-MARKET OBSERVATIONAL REGISTRY STUDY. ON (B)(6) 2021, THE PATIENT WAS IMPLANTED WITH TWO BIOMIMICS 3D (BM3D) STENTS. A 7.0 X 80 MM STENT AND A 7.0 X 150 MM STENT (THE SUBJECT OF THIS REPORT) WAS USED TO TREAT A DENOVO LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) PROXIMAL THIRD TO SFA MIDDLE THIRD IN THE LEFT LEG. A CONTRALATERAL APPROACH WAS USED AND THE LESION WAS PRE-DILATED WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA), AND AN INPACT DRUG COATED/ELUTING BALLOON (DCB/DEB) AND CUTTING BALLOON WERE USED. THE TREATED SEGMENT WAS POST-DILATED WITH PTA. ON THE (B)(6) 2022, THE SITE IDENTIFIED AN OCCLUSION. IT WAS REPORTED AS POSSIBLY RELATED TO THE DEVICE BUT NOT RELATED TO THE PROCEDURE. IT REQUIRED PERCUTANEOUS INTERVENTION. IT WAS REPORTED AS TARGET LESION RELATED. THE PATIENT HAD A COMPUTED TOMOGRAPHY (CT) SCAN THAT DEMONSTRATED THE LEFT SFA WAS 100% OCCLUDED. THE PATIENT THEN HAD PERCUTANEOUS INTERVENTION OF THE LEFT SFA PROXIMAL/MIDDLE PORTION, THAT WAS PREVIOUSLY TREATED WITH THE BM3D STENT. THE DISTAL SFA WAS ALSO TREATED. THIS SFA WAS SUCCESSFULLY TREATED WITH R

  Patient problems: Obstruction/Occlusion

  MAUDE report 20246114 ↗
• MalfunctionJul 1, 2024Fracture; Fracture

  ON 22-MAY-23, THREE BIOMIMICS 3D (BM3D) STENTS WERE IMPLANTED IN A PATIENT TO TREAT A COMPLETE CHRONIC OCCLUSION. THE PATIENT HAD A VASCULAR OCCLUSION FROM THE SUPERFICIAL FEMORAL ARTERY (SFA) OSTIAL TO POPLITEAL ARTERY P1 REGION, AND THERE WAS CALCIFICATION FROM THE SFA DISTAL TO POPLITEAL ARTERY P1 REGION, BUT THERE WAS NO TORTUOSITY OF THE VESSELS REPORTED. THE VESSEL WAS PREPARED USING PRE-DILATION WITH A 5.0 MM DIAMETER BALLOON. THE STENTS WERE DEPLOYED FROM THE DISTAL SIDE AND A CONTRALATERAL APPROACH WAS TAKEN. A 6F SHEATH AND A 0.035" GUIDEWIRE WERE USED. ONE 6.0 X 125 MM STENT WHICH WAS DEPLOYED FIRST, ONE 6.0 X 150 MM STENT WAS DEPLOYED SECOND AND A 7.0 X 150 MM STENT (THE SUBJECT OF THIS REPORT) WAS DEPLOYED LAST. THE 7.0 X 150 MM STENT WAS IMPLANTED IN THE SFA PROXIMAL TO SFA DISTAL SEGMENT. THE TREATED SEGMENT WAS POST-DILATED WITH A 5.0 X 240 MM JADE BALLOON. THERE WAS NO RESISTANCE OR OTHER ISSUES DURING STENT DEPLOYMENT, AND THERE WERE NO PROBLEMS REPORTED WITH THE DEPLOYMENT. ANGIOGRAPHY WAS PERFORMED JUST AFTER THE STENTS WERE DEPLOYED AND SHOWED NO ABNORMALITIES IN THE PLACED STENTS. THERE WERE NO PROBLEMS REPORTED WITH THE STENTS AFTER DEPLOYMENT. ON 18-MAR-24,

  Patient problems: Pseudoaneurysm

  MAUDE report 19645599 ↗
• InjuryJun 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS TREATED AS PART OF THE MIMICS 3D USA POST-MARKET OBSERVATIONAL STUDY. ON (B)(6)2022, THE PATIENT WAS IMPLANTED WITH ONE 7.0 X 150 MM BIOMIMICS 3D (BM3D) STENT, WHICH WAS USED TO TREAT A DENOVO LESION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) MIDDLE THIRD TO DISTAL THIRD IN THE LEFT LEG. A CONTRALATERAL APPROACH WAS USED AND THE LESION WAS PREPARED WITH CUTTTING BALLOON PRE-STENT PLACEMENT. THE TREATED SEGMENT WAS POST-DILATED WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). THE SITE REPORTED THAT ON (B)(6)2023, A RESTENOSIS OF TREATED SEGMENT (TARGET LESION) WAS IDENTIFIED. IT WAS REPORTED AS NOT RELATED TO THE DEVICE AND NOT RELATED TO THE PROCEDURE BUT DUE TO A WORSENING PRE-EXISTING CONDITION. IT WAS TARGET LESION RELATED. THE PATIENT HAD WORSENING CLAUDICATION IN THE LEFT LEG. A COMPUTED TOMOGRAPHY (CT) SCAN SHOWED A LEFT SFA WITH IN-STENT RESTENOSIS (ISR). THE PATIENT HAD RUTHERFORD CLASS 3 SYMPTOMS. IT WAS TREATED WITH PERIPHERAL INTERVENTION TO THE LEFT SFA. THE LEFT SFA HAD RESTENOSIS UP TO 90% AT THE PROXIMAL EDGE OF THE PREVIOUSLY PLACED STENT IN THE MID SFA WITH ADDITIONAL ISR UP 90% IN THE DISTAL PORTION OF THIS STENT (DISTAL SFA). THIS ENTIRE REGION (SFA

  Patient problems: Pain; Restenosis

  MAUDE report 19593299 ↗
• MalfunctionApr 4, 2024Fracture; Material Separation; Stretched; Difficult to Advance; Activation Failure; Physical Resistance/Sticking; Fracture; Material Separation; Stretched; Difficult to Advance; Activation Failure; Physical Resistance/Sticking

  ON (B)(6) 2024, A PHYSICIAN WAS USING A BIOMIMICS 3D (BM3D) 7.0 X 150 MM STENT SYSTEM. IT WAS REPORTED THAT THE SYSTEM HAD SOME RESISTANCE GOING THROUGH THE SHEATH BUT THE PHYSICIAN WAS ABLE TO ADVANCE IT TO THE TARGET SITE. THE FIRST TWO CENTIMETRES (2 CM) OF THE STENT DEPLOYED WITHOUT ISSUE. IT BECAME INCREASINGLY DIFFICULT TO DEPLOY THE STENT AND SIGNIFICANT RESISTANCE WAS EXPERIENCED. THE PHYSICIAN REPORTED THAT THIS LED TO A "SNAP" THAT WAS FELT AFTERWARD. THE PHYSICIAN REPORTED THAT PULLING BACK ON THE DEPLOYMENT MECHANISM DID NOT TRANSLATE TO ANY FURTHER DEPLOYMENT OF THE STENT. AT THIS POINT THE SHEATH WAS ADVANCED OVER THE ENTIRE BM3D STENT DEPLOYMENT SYSTEM AND IT WAS USED TO CAPTURE THE STENT. DURING THIS PROCESS, 2 CM OF THE STENT BROKE OFF AND REMAINED IN THE VESSEL. AFTER REMOVAL OF THE BM3D SYSTEM, THE PORTION OF STENT THAT REMAINED WAS CROSSED WITH A 0.035" WIRE AND A COMPETITOR STENT WAS DEPLOYED AND POST-DILATED TO AFFIX THE PORTION OF THE BM3D STENT AGAINST ARTERIAL FLOW. THE COMPLETION ANGIOGRAPHY SHOWED GOOD FLOW THROUGH THE VESSEL. THERE WAS NO IMPACT TO THE PATIENT REPORTED. IT WAS REPORTED THAT THE PHYSICIAN DOES NOT BELIEVE THE EVENT WAS RELATED TO THE DEVI

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 19039464 ↗
• InjuryApr 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS RELATED TO MDR REPORT 3011632150-2022-00106 AND 3011632150-2023-00124. THE PATIENT WAS TREATED AS PART OF THE MIMICS 3D USA POST-MARKET OBSERVATIONAL STUDY. ON THE (B)(6) 2021, THE PATIENT WAS IMPLANTED WITH ONE 7.0 X 60MM BIOMIMICS 3D (BM3D) STENT (THE SUBJECT OF REPORT 3011632150-2022-00106). THIS WAS USED TO TREAT A DENOVO LESION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) OSTIAL TO SFA PROXIMAL THIRD IN THE LEFT LEG. THE PATIENT ALSO HAD A 6.0 X 100MM BM3D STENT (THE SUBJECT OF REPORT 3011632150-2023-00124) PLACED IN THE LEFT SFA DISTAL THIRD TO PROXIMAL POPLITEAL SEGMENT ON (B)(6) 2022 FOR A RESTENOSIS. ON 05-MAR-24, ADDITIONAL INFORMATION WAS RECEIVED BY VERYAN WHERE THE SITE ADDED DETAILS OF A SECOND NON-STUDY COMMERCIAL BM3D STENT (A 7.0 X 150 MM STENT (THE SUBJECT OF THIS REPORT) WHICH WAS PLACED ON (B)(6) 2022 IN THE SFA MIDDLE THIRD TO TREAT A RESTENOSIS EVENT OF THE COMMON FEMORAL TO SFA MIDDLE THIRD SEGMENT. ALL IMPLANTATIONS USED A CONTRALATERAL APPROACH AND THE LESIONS WERE PREPARED USING STANDARD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) AND ATHERECTOMY. THE TREATED SEGMENTS WERE ALSO POST-DILATED WITH PTA. ON (B)(6) 2022, THE SITE IDENTIFIED A RESTENOS

  Patient problems: Cramp(s) /Muscle Spasm(s); Pain; Restenosis

  MAUDE report 19033467 ↗
• InjuryApr 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS TREATED AS PART OF THE MIMICS 3D USA POST-MARKET OBSERVATIONAL STUDY ON (B)(6) 2021. THE SUBJECT WAS IMPLANTED WITH ONE BIOMIMICS 3D (BM3D) STENT (A 7.0 X 150MM STENT) TO TREAT A RESTENOTIC LESION OF THE SFA MIDDLE THIRD TO SFA DISTAL THIRD ARTERY IN THE RIGHT LEG. A CONTRALATERAL APPROACH WAS USED AND THE LESION WAS PREPARED USING PRE-DILATATION WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) AND LASER ATHERECTOMY. THE TREATED SEGMENT WAS POST-DILATED WITH PTA. ON (B)(6) 2022, AN EVENT OF RESTENOSIS OF TREATED SEGMENT (TARGET LESION) WAS IDENTIFIED BY THE SITE. IT WAS REPORTED AS "NOT RELATED" TO THE DEVICE AND "NOT RELATED" TO THE PROCEDURE BUT WORSENING PRE-EXISTING CONDITION. IT WAS TARGET LESION-RELATED. THE RIGHT SFA STENT WAS TREATED WITH PLAIN OLD BALLOON ANGIOPLASTY (POBA) FOR IN-STENT RESTENOSIS (ISR). THE RIGHT OSTIAL SFA STENOSIS WAS TREATED WITH LASER ATHERECTOMY AND POBA. THE INTERVENTION WAS PERFORMED ON (B)(6) 2022 AND THE SEGMENT TREATED WAS THE SFA OSTIAL TO PROXIMAL POPLITEAL. THE PATIENT OUTCOME WAS REPORTED AS "RESOLVED/RECOVERED". IT WAS REPORTED AS A TARGET LESION REVASCULARISATION (TLR) AND TARGET VESSEL REVASCULARISATION (TVR). THE DEVICE R

  Patient problems: Restenosis

  MAUDE report 19032790 ↗
• MalfunctionMar 15, 2024Stretched; Activation Failure; Stretched; Activation Failure

  A 7.0 X 150 MM BIOMIMICS 3D (BM3D) STENT WOULD NOT FULLY DEPLOY AFTER THE OUTER SHEATH WAS COMPLETELY RETRACTED DURING A PROCEDURE ON (B)(6) 2024. THIS IS THE THIRD TIME THE SAME PHYSICIAN HAS EXPERIENCED THIS SINCE USING THE BM3D SYSTEM. MDR REPORTS 3011632150-2024-00011 AND 3011632150-2024-00012 ARE RELATED TO THESE TWO PREVIOUS OCCURRENCES.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18912480 ↗
• InjuryMar 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS RELATED TO MDR REPORT NUMBER 3011632150-2024-00007. THE PATIENT WAS TREATED AS PART OF THE MIMICS 3D USA POST-MARKET OBSERVATIONAL STUDY. ON (B)(6) 2021, THE PATIENT WAS IMPLANTED WITH TWO 7.0 X 150 MM BIOMIMICS 3D (BM3D) STENTS IN THE LEFT LEG TO TREAT A DENOVO LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) OSTIAL TO SFA DISTAL THIRD. A CONTRALATERAL APPROACH WAS USED AND THE LESION WAS PREPARED USING PRE-DILATION WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON AND ATHERECTOMY. THE TREATED SEGMENT WAS POST-DILATED WITH PTA. ON (B)(6) 2022, A RESTENOSIS OF THE TREATED SEGMENT (TARGET LESION) WAS IDENTIFIED. IT WAS REPORTED AS POSSIBLY RELATED TO THE DEVICE BUT NOT RELATED TO THE PROCEDURE. THE OUTCOME WAS REPORTED AS RESOLVED/RECOVERED. IT REQUIRED A PERCUTANEOUS INTERVENTION. THE EVENT WAS TREATED ON (B)(6) 2022. THIS INVOLVED DRUG DRUG-COATED BALLOON / DRUG-ELUTING BALLOON (DCB/DEB), PTA/STANDARD BALLOON ANGIOPLASTY AND LASER ATHERECTOMY ON THE SFA PROXIMAL THIRD TO THE SFA DISTAL THIRD. IT WAS TARGET LESION RELATED AND RESULTED IN TARGET LESION REVASCULARIZATION (TLR) AND TARGET VESSEL REVASCULARIZATION (TVR). THE DEVICES REMAIN IMPLANTED.

  Patient problems: Restenosis

  MAUDE report 18853909 ↗
• InjuryMar 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS RELATED TO MDR REPORT NUMBER 3011632150-2024-00008. THE PATIENT WAS TREATED AS PART OF THE MIMICS 3D USA POST-MARKET OBSERVATIONAL STUDY. ON (B)(6) 2021, THE PATIENT WAS IMPLANTED WITH TWO 7.0 X 150 MM BIOMIMICS 3D (BM3D) STENTS IN THE LEFT LEG TO TREAT A DENOVO LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) OSTIAL TO SFA DISTAL THIRD. A CONTRALATERAL APPROACH WAS USED AND THE LESION WAS PREPARED USING PRE-DILATION WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON AND ATHERECTOMY. THE TREATED SEGMENT WAS POST-DILATED WITH PTA. ON (B)(6) 2022, A RESTENOSIS OF THE TREATED SEGMENT (TARGET LESION) WAS IDENTIFIED. IT WAS REPORTED AS POSSIBLY RELATED TO THE DEVICE BUT NOT RELATED TO THE PROCEDURE. THE OUTCOME WAS REPORTED AS RESOLVED/RECOVERED. IT REQUIRED A PERCUTANEOUS INTERVENTION. THE EVENT WAS TREATED ON (B)(6) 2022. THIS INVOLVED DRUG DRUG-COATED BALLOON / DRUG-ELUTING BALLOON (DCB/DEB), PTA/STANDARD BALLOON ANGIOPLASTY AND LASER ATHERECTOMY ON THE SFA PROXIMAL THIRD TO THE SFA DISTAL THIRD. IT WAS TARGET LESION RELATED AND RESULTED IN TARGET LESION REVASCULARIZATION (TLR) AND TARGET VESSEL REVASCULARIZATION (TVR). THE DEVICES REMAIN IMPLANTED.

  Patient problems: Restenosis

  MAUDE report 18853906 ↗
• MalfunctionOct 27, 2023Material Separation; Stretched; Detachment of Device or Device Component; Activation Failure; Physical Resistance/Sticking; Material Separation; Stretched; Detachment of Device or Device Component; Activation Failure; Physical Resistance/Sticking

  ON THE (B)(6) 2023, A PHYSICIAN WAS ATTEMPTING TO TREAT THE SUPERFICIAL FEMORAL ARTERY (SFA) WITH A BIOMIMICS 3D (BM3D) 7.0 X 150 MM DEVICE VIA A PEDAL APPROACH. THE PATIENT'S VESSEL ANATOMY HAD MILD TORTUOSITY IN THE ANTERIOR TIBIAL ARTERY AND MILD CALCIFICATION IN THE TARGET LESION. A MERIT MEDICAL 5/6 FR SLENDER ACCESS SHEATH WAS USED. A 0.035" GLIDEWIRE ADVANTAGE GUIDEWIRE WAS USED ALSO. BEFORE STENT IMPLANTATION, THE VESSEL WAS PREPARED WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON AND LASER ATHERECTOMY. THE DEVICE WAS FLUSHED IN ACCORDANCE WITH THE IFU AND THEN INTRODUCED INTO THE PATIENT. THE SLACK WAS REMOVED FROM THE DELIVERY SYSTEM AND DEPLOYMENT OF THE STENT WAS INITIATED WHILE KEEPING THE PROXIMAL PIN LUER IN A FIXED POSITION. THE PHYSICIAN EXPERIENCED RESISTANCE IMMEDIATELY UPON INITIATING DEPLOYMENT AND BEFORE THE RELEASE OF ANY STENT CROWNS FROM THE OUTER BRAID. THE PHYSICIAN CONTINUED TO DEPLOY THE STENT AND MANAGED TO DEPLOY APPROXIMATELY 50% OF THE STENT'S LENGTH. THE CONTINUED DEPLOYMENT RESULTED IN THE FAILURE OF THE OUTER BRAID TO BIFURCATION HUB BOND BEFORE THE STENT HAD BEEN COMPLETELY DEPLOYED CULMINATING IN A PARTIAL DEPLOYMENT. AT THIS POINT, TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18021066 ↗
• InjuryOct 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS TREATED AS PART OF THE MIMICS 3D USA POST-MARKET OBSERVATIONAL STUDY. ON THE (B)(6) 2021, THE PATIENT WAS IMPLANTED WITH ONE 7.0 X 150 MM BIOMIMICS 3D (BM3D) STENT IN THE RIGHT LEG TO TREAT A DENOVO LESION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) MIDDLE THIRD TO DISTAL THIRD. A CONTRALATERAL APPROACH WAS USED AND THE LESION WAS PREPARED WITH ATHERECTOMY. THE TREATED SEGMENT WAS POST-DILATED WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON. THE SITE IDENTIFIED A RESTENOSIS OF TREATED SEGMENT (TARGET LESION) ON (B)(6) 2022. IT WAS REPORTED AS NOT RELATED TO THE STUDY DEVICE AND NOT RELATED TO THE STUDY PROCEDURE. IT WAS DUE TO A WORSENING PRE-EXISTING CONDITION. IT WAS TARGET LESION RELATED. THE PATIENT PRESENTED AT THE CLINIC FOR A FOLLOW-UP VISIT ON (B)(6) 2022 WITH WORSENING CLAUDICATION SYMPTOMS AND RUTHERFORD CLASS (RC) 3 SYMPTOMS. A BILATERAL LEG EXTREMITY (BLE) DIAGNOSTIC ANGIOGRAM WAS COMPLETED ON (B)(6) 2022 AND IDENTIFIED MODERATE IN-STENT STENOSIS OF DISTAL SFA (TARGET LESION) AND AN INTERVENTION WAS SCHEDULED. A STENT PLACEMENT WAS PERFORMED ON (B)(6) 2023 ON THE LEFT PROXIMAL SFA (NON-STUDY LEG). AN INTERVENTION WAS PERFORMED ON (B)(6) 2023 AND INV

  Patient problems: Pain; Restenosis

  MAUDE report 17865148 ↗
• MalfunctionOct 3, 2023Break; Material Separation; Stretched; Activation Failure; Physical Resistance/Sticking; Break; Material Separation; Stretched; Activation Failure; Physical Resistance/Sticking

  ON THE (B)(6) 2023, A PHYSICIAN ATTEMPTED TO DEPLOY A 7.0 X 150 MM BIOMIMICS 3D STENT (BM3D) VIA PEDAL ANTERIOR TIBIAL ARTERY (ATA) ACCESS INTO THE PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA) WHEN THE PULL BACK PORTION OF THE SHEATH BROKE. THE PHYSICIAN REPORTED THAT THE ATA WAS PREVIOUSLY OCCLUDED AND TIGHT AROUND THE SHEATH WHICH WAS PROBABLY A FACTOR IN LEADING TO THE REPORTED SHEATH BREAK. THE PHYSICIAN WAS ABLE TO RETRACT THE SHEATH AND FINISH THE DEPLOYMENT BUT IT WAS REPORTED AS BEING VERY ELONGATED AFTERWARDS. IT WAS REPORTED BY THE PHYSICIAN AS BEING PATENT AFTERWARDS THROUGH A PREVIOUSLY OCCLUDED SFA. THE PHYSICIAN REPORTED THAT HE MAY HAVE TO BRING THE PATIENT BACK AND STENT THROUGH IT. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17864972 ↗
• MalfunctionSep 5, 2023Fracture; Stretched; Activation Failure; Physical Resistance/Sticking; Fracture; Stretched; Activation Failure; Physical Resistance/Sticking

  THIS IS RELATED TO USER FACILITY REPORT NUMBER: (B)(4). ON (B)(6) 2023, A PHYSICIAN ATTEMPTED TO TREAT A 240 MM LESION IN THE DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) USING A 7.0 X 150 MM BIOMIMICS 3D STENT (BM3D). THE PATIENT'S VESSEL HAD MILD CALCIFICATION IN THE SFA AND THE COMMON FEMORAL ARTERY (CFA) WAS REPORTED AS SLIGHTLY TORTUOUS. THE AORTIC BIFURCATION ANGLE WAS TIGHT. THE PHYSICIAN USED A CONTRALATERAL APPROACH WITH A 7 FR ACCESS SHEATH AND A 0.035" GUIDEWIRE. THE PHYSICIAN HAD SLIGHT DIFFICULTY IN CROSSING THE AORTIC BIFURCATION WITH THE ACCESS SHEATH DUE TO ITS TIGHT ANGLE. THE PHYSICIAN MANAGED TO GET THE ACCESS SHEATH IN PLACE. PRIOR TO THE BM3D STENT IMPLANTATION, THE TARGET VESSEL WAS TREATED USING SHOCKWAVE INTRAVASCULAR LITHOTRIPSY (IVL). THE BM3D DEVICE WAS FLUSHED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU) AND INTRODUCED INTO THE PATIENT'S VESSEL. IT WAS NOTED THAT THE PHYSICIAN DID NOT EXPERIENCE ANY COMPLICATIONS CROSSING THE AORTIC BIFURCATION WITH THE BM3D DEVICE. AT THIS POINT IN THE PROCEDURE SLACK WAS REMOVED FROM THE DEVICE AND THE DEPLOYMENT OF THE STENT WAS INITIATED WHILE THE PROXIMAL PIN LUER WAS HELD IN A FIXED POSITION. A SMALL PORTION OF THE

  Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17683775 ↗
• InjuryJul 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS RELATED TO MDR NUMBER 3011632150-2023-00089. THE PATIENT WAS TREATED AS PART OF THE MIMICS 3D USA POST-MARKET OBSERVATIONAL STUDY. ON THE (B)(6) 2021, THE PATIENT WAS IMPLANTED WITH TWO BIOMIMICS 3D (BM3D) STENTS, A 7.0 X 150 MM STENT (THE SUBJECT OF THIS REPORT) AND A 7.0 X 80 MM STENT WHICH WERE USED TO TREAT A RESTENOTIC LESION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) MIDDLE THIRD TO PROXIMAL POPLITEAL ARTERY IN THE RIGHT LEG. A RETROGRADE APPROACH WAS USED AND THE LESION WAS PREPARED USING PRE-DILATION WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON AND ATHERECTOMY. THE TREATED SEGMENT WAS POST-DILATED WITH PTA. THE SITE IDENTIFIED A RESTENOSIS OF TREATED SEGMENT (TARGET LESION) ON (B)(6) 2023. IT WAS REPORTED AS DEFINITELY RELATED TO THE DEVICE AND NOT RELATED TO THE PROCEDURE. IT WAS ALSO REPORTED AS TARGET LESION-RELATED. THE PATIENT HAD AN ANKLE-BRACHIAL INDEX (ABI) AND DUPLEX ULTRASOUND (DUS) ON (B)(6) 2023. THE ABI ON THE RIGHT WAS MEASURED AT 0.92 (RESTING) AND DUS SHOWED MONOPHASIC WAVEFORMS THROUGHOUT AND ELEVATED VELOCITIES. THE PATIENT WAS EXPERIENCING SYMPTOMS CONSISTENT WITH RUTHERFORD CLASS 3 (WORSENING LEG PAIN, ACHING WITH MINIMAL AMOUNT O

  Patient problems: Pain; Restenosis

  MAUDE report 17279996 ↗
• InjuryJul 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS RELATED TO MDR NUMBER 3011632150-2023-00087. THE PATIENT WAS TREATED AS PART OF THE MIMICS 3D USA POST-MARKET OBSERVATIONAL STUDY. ON THE (B)(6) 2021, THE PATIENT WAS IMPLANTED WITH TWO BIOMIMICS 3D (BM3D) STENTS, A 7.0 X 150 MM STENT (THE SUBJECT OF THIS REPORT) AND A 7.0 X 80 MM STENT WHICH WERE USED TO TREAT A DENOVO LESION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) MIDDLE THIRD TO PROXIMAL POPLITEAL ARTERY IN THE RIGHT LEG. A RETROGRADE APPROACH WAS USED AND THE LESION WAS PREPARED USING PRE-DILATION WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON AND ATHERECTOMY. THE TREATED SEGMENT WAS POST-DILATED WITH PTA. THE SITE IDENTIFIED A RESTENOSIS OF TREATED SEGMENT (TARGET LESION) ON (B)(6) 2022. IT WAS REPORTED AS DEFINITELY RELATED TO THE DEVICE AND NOT RELATED TO THE PROCEDURE. IT WAS ALSO REPORTED AS TARGET LESION RELATED. THE PATIENT HAD A 12-MONTH ANKLE BRACHIAL INDEX (ABI) AND DUPLEX ULTRASOUND (DUS) ON THE (B)(6) 2022. THE ABI ON THE RIGHT WAS MEASURED AT 0.37 (RESTING) AND DUS SHOWED MONOPHASIC WAVEFORMS THROUGHOUT AND ELEVATED VELOCITIES. THE PATIENT WAS EXPERIENCING SYMPTOMS CONSISTENT WITH RUTHERFORD CLASS 3. A DIAGNOSTIC ANGIOGRAM ON (B)(6) 2022 ID

  Patient problems: Pain; Restenosis

  MAUDE report 17279924 ↗
• InjuryJun 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS RELATED TO MDR NUMBER 3011632150-2023-00071. THE PATIENT WAS TREATED AS PART OF THE MIMICS 3D USA POST-MARKET OBSERVATIONAL STUDY. ON THE (B)(6) 2022, THE PATIENT WAS IMPLANTED WITH ONE BIOMIMICS 3D (BM3D) STENT, A 7.0 X 60MM STENT WHICH WAS USED TO TREAT A DE NOVO LESION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) PROXIMAL THIRD IN THE RIGHT LEG. A RETROGRADE APPROACH WAS USED AND THE LESION WAS PREPARED USING PRE-DILATION WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON AND ATHERECTOMY. THE TREATED SEGMENT WAS ALSO POST-DILATED WITH PTA. ANOTHER BM3D 7.0 X 150MM STENT (THE SUBJECT OF THIS REPORT) WAS IMPLANTED ON (B)(6) 2022 IN THE SFA PROXIMAL THIRD TO SFA MIDDLE THIRD FOR A RESTENOSIS OF TREATED VESSEL (TARGET VESSEL). THE SITE IDENTIFIED A RESTENOSIS OF TREATED SEGMENT (TARGET LESION) ON (B)(6) 2023. THE PATIENT'S IMAGING WHICH INCLUDED DIAGNOSTIC INTRAVASCULAR ULTRASOUND (IVUS) NON-INTERVENTIONAL ASSESSMENT OF THE RIGHT SFA SHOWED THE FOLLOWING FINDINGS: THERE WAS A STENT EXTENDING FROM THE OSTIUM OF THE SFA DOWN TO THE PROXIMAL/MID SFA SEGMENT WHICH WAS COMPLETELY OCCLUDED. THE MID TO DISTAL RIGHT SFA HAD A STENT THAT RECANALISED VIA COLLATERALS FROM THE PROFUNDA

  Patient problems: Obstruction/Occlusion; Restenosis

  MAUDE report 17169887 ↗
• MalfunctionJun 9, 2023Fracture; Stretched; Deformation Due to Compressive Stress; Detachment of Device or Device Component; Activation Failure; Separation Problem; Fracture; Stretched; Deformation Due to Compressive Stress; Detachment of Device or Device Component; Activation Failure; Separation Problem

  ON (B)(6) 2023, A PHYSICIAN ATTEMPTED TO TREAT THE MID AND DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) OF A PATIENT USING A 7.0 X 150MM BIOMIMICS 3D (BM3D) STENT. THE PATIENT ANATOMY HAD DIFFUSE DISEASE AND MILD TO MODERATE CALCIFICATION IN THE SFA. A CONTRALATERAL APPROACH WAS USED AND A 6FR COOK FLEXOR 55 CM ACCESS SHEATH WAS USED WITH A 0.035" GLIDEWIRE AND A 0.014" VIPER GUIDEWIRES. THE VESSEL WAS PREPARED USING LASER ATHERECTOMY WITH A CARDIOVASCULAR SYSTEMS INC (CSI) DIAMONDBACK DEVICE. THE BM3D DEVICE WAS FLUSHED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO ISSUES REPORTED WHEN CROSSING THE AORTIC BIFURCATION. THE SLACK WAS REMOVED FROM THE DEVICE AND THE DEPLOYMENT OF THE DEVICE WAS INITIATED WHILE HOLDING THE PROXIMAL PIN LUER HUB IN A FIXED POSITION. HOWEVER, RESISTANCE WAS EXPERIENCED IMMEDIATELY UPON INITIATION OF DEPLOYMENT PRIOR TO THE RELEASE OF ANY STENT CROWNS FROM THE OUTER BRAID. THE PHYSICIAN CONTINUED THE DEPLOYMENT ATTEMPT AND RELEASED 1CM OF THE STENT. THE RELEASED STENT DID NOT OPPOSE THE VESSEL WALL. THE PHYSICIAN FELT A SNAP IN THE DELIVERY SYSTEM AT THIS POINT IN THE DEPLOYMENT. THE STENT COULD NO LONGER BE DEPLOYED AND THE DELIVERY SYSTEM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17098143 ↗
• MalfunctionMay 23, 2023Stretched; Deformation Due to Compressive Stress; Activation Failure; Physical Resistance/Sticking; Stretched; Deformation Due to Compressive Stress; Activation Failure; Physical Resistance/Sticking

  ON (B)(6) 2023, A PHYSICIAN ATTEMPTED TO TREAT A LONG SEGMENT OF DISEASE IN THE SUPERFICIAL FEMORAL ARTERY (SFA) USING A 7.0 X 150MM BIOMIMICS 3D STENT (BM3D). THE PATIENT ANATOMY WAS DESCRIBED AS HAVING MINIMAL CALCIFICATION. THE VESSEL WAS WITHOUT ANY NOTEWORTHY TORTUOSITY. A PEDAL APPROACH WAS USED AND A GLIDEWIRE ADVANTAGE GUIDEWIRE WITH A 6FR SLENDER ACCESS SHEATH WERE USED. THE TARGET VESSEL WAS PREPARED USING BALLOON ANGIOPLASTY. THE DEVICE WAS FLUSHED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU) AND INTRODUCED INTO THE PATIENT. THERE WAS RESISTANCE EXPERIENCED BY THE PHYSICIAN WHILE ADVANCING THE DEVICE TO THE TARGET SITE. THE PHYSICIAN REMOVED SLACK FROM THE DELIVERY SYSTEM AND DEPLOYMENT WAS INITIATED. THE PROXIMAL PIN LUER WAS HELD IN A FIXED POSITION. THERE WAS RESISTANCE UPON INITIATION OF THE DEPLOYMENT. NONE OF THE STENT CROWNS WERE RELEASED. IT WAS REPORTED THAT THE OUTER BRAID "SEEMED TO STRETCH" AND THAT THE DELIVERY SYSTEM WAS BECOMING DAMAGED DUE TO THE RESISTANCE. THE RESISTANCE "SEEMED TO PRODUCE IRREGULARITIES IN THE OUTER CATHETER AND THE INNER CORE OF THE DELIVERY SYSTEM SEEMED TO KINK". DUE TO THE "EXTREME FORCE" EXPERIENCED DURING THE DEPLOYMENT, THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16982619 ↗
• InjuryMay 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS TREATED AS PART OF THE MIMICS 3D USA POST-MARKET OBSERVATIONAL STUDY. ON (B)(6) 2021, THE PATIENT WAS IMPLANTED WITH ONE BIOMIMICS 3D (BM3D) STENT, A 7.0 X 150MM STENT WHICH WAS USED TO TREAT A RESTENOTIC LESION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) MIDDLE THIRD TO DISTAL THIRD IN THE RIGHT LEG. A CONTRALATERAL APPROACH WAS USED AND THE LESION WAS PREPARED USING PRE-DILATION WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON AND ATHERECTOMY. THE TREATED SEGMENT WAS ALSO POST-DILATED WITH PTA. THE SITE REPORTED THAT ON (B)(6) 2022, A RESTENOSIS OF TREATED SEGMENT (TARGET LESION) WAS IDENTIFIED. IT WAS REPORTED AS NOT RELATED TO THE DEVICE AND NOT RELATED TO THE PROCEDURE BUT DUE TO A WORSENING PRE-EXISTING CONDITION. IT WAS REPORTED AS TARGET LESION-RELATED AND REQUIRED PERCUTANEOUS INTERVENTION. THE PATIENT HAD RIGHT LOWER EXTREMITY (RLE) CLAUDICATION AND A RIGHT SFA IN-STENT RESTENOSIS (ISR) WHICH WAS IDENTIFIED ON AN ANGIOGRAM ON (B)(6) 2022. A RLE ANGIOGRAM WAS PERFORMED WITH AN INTERVENTION THAT INVOLVED LASER ATHERECTOMY AND PTA/STANDARD BALLOON ANGIOPLASTY/PLAIN OLD BALLOON ANGIOPLASTY (POBA) OF THE DISTAL HALF OF THE MID TO DISTAL SFA/POPLITEAL (POP)

  Patient problems: Pain; Restenosis

  MAUDE report 16916501 ↗
• MalfunctionApr 5, 2023Fracture; Difficult or Delayed Activation; Fracture; Difficult or Delayed Activation

  ON 08-MAR-23, A PHYSICIAN ATTEMPTED TO TREAT THE DISTAL EXTERNAL ILIAC ARTERY, COMMON FEMORAL ARTERY AND PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA) OF THE PATIENT'S RIGHT LEG USING A BIOMIMICS 3D (BM3D) 7.0 X 150MM STENT. THE PATIENT'S VESSEL ANATOMY WAS DESCRIBED AS BEING HEAVILY CALCIFIED, DIFFUSE DISEASE IN THE RIGHT SFA AND COMMON FEMORAL ARTERY AS WELL AS SIGNIFICANT DISEASE IN THE RIGHT EXTERNAL ARTERY. A PEDAL APPROACH WAS USED WITH A 6 FR TERUMO SLENDER ACCESS SHEATH AND COMMAND GUIDEWIRE AND PRIOR TO IMPLANTATION THE VESSEL WAS PREPARED USING LASER/ATHERECTOMY, AND BALLOON ANGIOPLASTY. THE DELIVERY SYSTEM WAS FLUSHED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). THE TARGET SITE WAS IN THE RIGHT EXTERNAL ILIAC VESSEL. THE DEVICE WAS ADVANCED TO THE TARGET SITE, WITHOUT ANY ISSUE, AND THE PHYSICIAN BEGAN INITIATING DEPLOYMENT OF THE STENT. THE PHYSICIAN SUCCESSFULLY RELEASED A PORTION OF THE BM3D STENT BUT THEN EXPERIENCED RESISTANCE PRIOR TO COMPLETING DEPLOYMENT. USING SOME ADDITIONAL FORCE, THE FULL LENGTH OF THE STENT WAS RELEASED. IT WAS AT THIS POINT THAT THE PHYSICIAN IDENTIFIED THE POTENTIAL STENT FRACTURE IN THE PROXIMAL PORTION OF THE STENT. ADDITIONAL STENTING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16680348 ↗
• InjuryMar 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS TREATED AS PART OF THE MIMICS 3D USA POST-MARKET OBSERVATIONAL STUDY. ON THE (B)(6) 2021, THE PATIENT WAS IMPLANTED WITH ONE BIOMIMICS 3D (BM3D) STENT, A 7.0 X 150MM STENT WHICH WAS USED TO TREAT A DENOVO LESION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) MIDDLE THIRD TO DISTAL THIRD SEGMENT IN THE RIGHT LEG. A RETROGRADE APPROACH WAS USED AND THE LESION WAS PREPARED USING PRE-DILATION WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON AND ATHERECTOMY. THE SITE REPORTED THAT ON (B)(6) 2022, A RESTENOSIS OF TREATED SEGMENT (TARGET LESION) WAS IDENTIFIED. THE PATIENT UNDERWENT PERCUTANEOUS CORONARY INTERVENTION (PCI) DURING WHICH LOWER EXTREMITY ANGIOGRAPHY WAS ALSO PERFORMED. THE RIGHT LEG WAS FOUND TO HAVE MILD DISEASE IN THE PROXIMAL MID SFA, THE DISTAL SFA HAD 80% FLOW LIMITING STENOSIS AND THE POPLITEAL ARTERY HAD MILD DISEASE. DISTALLY, THERE APPEARED TO BE THREE-VESSEL RUNOFF THAT INVOLVED THE TIBIAL ARTERIES ON THE RIGHT. THE ANTERIOR AND POSTERIOR TIBIAL ARTERIES HAD HIGH GRADE STENOSIS PROXIMALLY. THE PATIENT ALSO HAD RUTHERFORD CLASS IV SYMPTOMS. THE INTERVENTION ON (B)(6) 2022 INVOLVED BARE METAL STENT PLACEMENT, PTA STANDARD BALLOON ANGIOPLASTY AND LASE

  Patient problems: Restenosis

  MAUDE report 16644699 ↗
• InjuryJan 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS RELATED TO MDR REPORT NUMBER 3011632150-2023-00004. THE PATIENT WAS TREATED AS PART OF THE MIMICS 3D USA POST-MARKET OBSERVATIONAL STUDY. ON (B)(6) 2021, THE PATIENT WAS IMPLANTED WITH TWO 7 X 150MM BIOMIMICS 3D (BM3D) STENTS AND THEY WERE USED TO TREAT A RESTENOTIC LESION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) PROXIMAL THIRD TO PROXIMAL POPLITEAL SEGMENT IN THE LEFT LEG. A CONTRALATERAL APPROACH WAS USED AND THE LESION WAS PREPARED USING ATHERECTOMY AND PRE-DILATED WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). THE LESION WAS POST-DILATED WITH PTA AND ANOTHER NON BIOMIMICS STENT WAS ALSO IMPLANTED AFTER THE BM3D STENTS. THE SITE REPORTED THAT ON (B)(6) 2021, A RESTENOSIS OF TREATED SEGMENT (TARGET LESION) WAS IDENTIFIED. IT WAS REPORTED AS NOT RELATED TO THE DEVICE OR THE PROCEDURE BUT DUE TO A WORSENING OF THE PRE-EXISTING CONDITION AND IT WAS REPORTED AS TARGET LESION RELATED. THE SUCCESSFUL INTERVENTION TOOK PLACE ON (B)(6) 2021 AND CONSISTED OF A NON BM3D BARE METAL STENT AND PTA/STANDARD BALLOON ANGIOPLASTY OF THE SFA PROXIMAL THIRD TO PROXIMAL POPLITEAL SEGMENT. THIS WAS REPORTED AS A TARGET LESION REVASCULARISATION (TLR)/TARGET VESSEL REVASCULARISATION (TVR). TH

  Patient problems: Restenosis

  MAUDE report 16172816 ↗
• InjuryJan 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS RELATED TO MDR REPORT NUMBER 3011632150-2023-00005. THE PATIENT WAS TREATED AS PART OF THE MIMICS 3D USA POST-MARKET OBSERVATIONAL STUDY. ON THE (B)(6) 2021, THE PATIENT WAS IMPLANTED WITH TWO 7 X 150MM BIOMIMICS 3D (BM3D) STENTS AND THEY WERE USED TO TREAT A RESTENOTIC LESION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) PROXIMAL THIRD TO PROXIMAL POPLITEAL SEGMENT IN THE LEFT LEG. A CONTRALATERAL APPROACH WAS USED AND THE LESION WAS PREPARED USING ATHERECTOMY AND PRE-DILATED WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). THE LESION WAS POST-DILATED WITH PTA AND ANOTHER NON BIOMIMICS STENT WAS ALSO IMPLANTED AFTER THE BM3D STENTS. THE SITE REPORTED THAT ON (B)(6) 2021, A RESTENOSIS OF TREATED SEGMENT (TARGET LESION) WAS IDENTIFIED. IT WAS REPORTED AS NOT RELATED TO THE DEVICE OR THE PROCEDURE BUT DUE TO A WORSENING OF THE PRE-EXISTING CONDITION AND IT WAS REPORTED AS TARGET LESION RELATED. THE SUCCESSFUL INTERVENTION TOOK PLACE ON (B)(6) 2021 AND CONSISTED OF A NON BM3D BARE METAL STENT AND PTA/STANDARD BALLOON ANGIOPLASTY OF THE SFA PROXIMAL THIRD TO PROXIMAL POPLITEAL SEGMENT. THIS WAS REPORTED AS A TARGET LESION REVASCULARISATION (TLR)/TARGET VESSEL REVASCULARISATION (TVR)

  Patient problems: Restenosis

  MAUDE report 16172814 ↗