BioMimics 3D Vascular Stent System 142122-11Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 05391526850466), received between Feb 8, 2022 and Dec 3, 2024 — classified as 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Activation Failure” (1 report).

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryDec 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT RELATES TO MDR 3011632150-2024-00057. 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 100 MM STENT (THE SUBJECT OF THIS REPORT) AND A 6.0 X 60 MM STENT WERE USED TO TREAT A DENOVO LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) MIDDLE THIRD TO SFA DISTAL THIRD IN THE RIGHT LEG. A RETROGRADE APPROACH WAS USED AND THE LESION WAS PREPARED WITH ATHERECTOMY AND POST-DILATED WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON. ON (B)(6) 2023, THE SITE IDENTIFIED A RESTENOSIS OF TREATED SEGMENT (TARGET LESION). IT WAS REPORTED AS NOT RELATED TO THE DEVICE AND NOT RELATED TO THE PROCEDURE BUT DUE TO A WORSENING PRE-EXISTING CONDITION. IT REQUIRED PERCUTANEOUS INTERVENTION. IT WAS REPORTED AS TARGET LESION RELATED. THE INTERVENTION WAS PERFORMED ON (B)(6) 2023 ON THE SFA PROXIMAL THIRD TO DISTAL POPLITEAL SEGMENT. A NON-BM3D BARE METAL STENT WAS PLACED, PTA/STANDARD BALLOON ANGIOPLASTY AND LASER ATHERECTOMY WERE USED TO TREAT THE RESTENOSIS. IT WAS A TARGET LESION/VESSEL REVASCULARISATION (TLR/TVR). THE SITE REPORTED "PRE-TREATMENT - RIGHT SFA: 81.4

  Patient problems: Restenosis

  MAUDE report 20833050 ↗
• MalfunctionOct 9, 2024Fracture; Stretched; Activation Failure; Fracture; Stretched; Activation Failure

  ON (B)(6) 2024, A PHYSICIAN WAS USING A BIOMIMICS 3D (BM3D) 7.0 X 100 MM STENT AND THEY REPORTED THAT THE STENT FRACTURED AT THE END, WHILE DEPLOYING IT TO OVERLAP WITH ANOTHER PREVIOUSLY PLACED STENT IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE COMPLAINT INVESTIGATION WAS COMPLETED ON (B)(6)2024, AND ONE IMAGE WAS RECEIVED AND REVIEWED BY THE INVESTIGATION TEAM WHICH CONFIRMED THAT THE STENT WAS PLACED IN A TARGET LESION IN THE SFA OF THE PATIENT'S RIGHT LEG. IT WAS DEPLOYED FULLY AND STENT ELONGATION WAS IDENTIFIED. NO ADDITIONAL INFORMATION WAS PROVIDED BY THE SITE DESPITE MULTIPLE REQUESTS BY VERYAN. THE SITE CONFIRMED THAT THEY HAD COMPLETED A COMPUTED TOMOGRAPHY (CT) SCAN ON THE PATIENT AND WOULD NOT PROVIDE ANY ADDITIONAL INFORMATION UNTIL A FOLLOW-UP ANGIOGRAM/RE-INTERVENTION HAD TAKEN PLACE. THE SITE DID NOT PROVIDE ANY TIMELINES AS TO WHEN THIS FOLLOW-UP WOULD BE PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20407922 ↗
• InjuryMar 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS TREATED AS PART OF THE (B)(6) STUDY ON (B)(6) 2021. THE SUBJECT WAS IMPLANTED WITH ONE BIOMIMICS 3D (BM3D) STENT (A 7.0 X 100 MM STENT) TO TREAT A DENOVO LESION OF THE SFA MIDDLE THIRD TO SFA DISTAL THIRD ARTERIAL SEGMENT IN THE LEFT LEG. A CONTRALATERAL APPROACH WAS USED AND THE LESION WAS PREPARED USING ATHERECTOMY. THE TREATED SEGMENT WAS POST-DILATED WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). ON (B)(6) 2023 AN EVENT OF OCCLUSION AND RESTENOSIS OF THE TREATED VESSEL WERE IDENTIFIED. THEY WERE REPORTED AS POSSIBLY RELATED TO THE DEVICE AND NOT RELATED TO THE PROCEDURE. THEY WERE BOTH REPORTED AS TARGET LESION-RELATED. THE PATIENT PRESENTED FOR THEIR 12-MONTH FOLLOW-UP AND A CONTINUED ULCER WITH QUESTIONABLE CLAUDICATION DUE TO NEUROPATHY WERE NOTED. A BILATERAL LOWER EXTREMITY (BLE) DIAGNOSTIC ANGIOGRAM WAS COMPLETED ON (B)(6) 2023 AND NOTED AN OCCLUSION OF THE MID-SFA THROUGH TO THE DISTAL POPLITEAL AND SEVERE IN THE PROXIMAL SFA. AN INTERVENTION WAS PERFORMED ON (B)(6) 2023. THE SFA PROXIMAL THIRD TO THE DISTAL POPLITEAL SEGMENT WAS TREATED WITH A NON-BM3D BARE METAL STENT, PTA/STANDARD BALLOON ANGIOPLASTY AND LASER/ATHERECTOMY. THE INTERVENTION WAS TARGE

  Patient problems: Obstruction/Occlusion; Pain; Restenosis

  MAUDE report 18966316 ↗
• InjuryDec 7, 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 100MM BIOMIMICS 3D (BM3D) STENT, WHICH WAS USED TO TREAT A DENOVO LESION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) 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. ON THE (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. IT REQUIRED PERCUTANEOUS INTERVENTION. THE INTERVENTION WAS PERFORMED ON (B)(6) 2023 AND INVOLVED DRUG COATED/ELUTING BALLOON (DCB/DEB) OF THE SFA DISTAL THIRD TO PROXIMAL POPLITEAL ARTERY. THE INTERVENTION WAS REPORTED AS A TARGET LESION/VESSEL REVASCULARISATION (TLR/TVR). THE EVENT WAS REVIEWED BY VERYAN AND CONSIDERED POSSIBLY RELATED TO THE DEVICE. THE PATIENT OUTCOME WAS REPORTED AS RESOLVED/RECOVERED. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Restenosis

  MAUDE report 18281133 ↗
• InjuryMar 27, 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 100MM 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 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. THE PATIENT EXPERIENCED RIGHT LEG EXTREMITY (RLE) CLAUDICATION. AN INTERVENTION ON (B)(6) 2022 INVOLVED PTA/STANDARD BALLOON ANGIOPLASTY AND LASER ATHERECTOMY OF THE SFA DISTAL THIRD TO PROXIMAL POPLITEAL ARTERY. IT WAS REPORTED AS A TARGET LESION REVASCULARISATION (TLR) AND TARGET VESSEL REVASCULARISATION (TVR). THE PATIENT OUTCOME WAS REPORTED AS RESOLVED/RECOVERED AND THE DEVICE REMAINS IMPLANT

  Patient problems: Pain; Restenosis

  MAUDE report 16622860 ↗
• InjuryNov 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS RELATED TO MDR NUMBER 3011632150-2022-00099. THE PATIENT WAS ENROLLED IN THE MIMICS 3D USA REGISTRY STUDY ON 21-JUL-21. TWO BIOMIMICS 3D (BM3D) STENTS WERE IMPLANTED TO TREAT RESTENOTIC LESIONS IN THE LEFT LEG. ONE STENT (A 7X 60MM STENT) WAS PLACED IN THE SFA MIDDLE THIRD AND THE OTHER (A 7.0 X 100MM STENT) WAS PLACED IN THE SFA DISTAL THIRD TO PROXIMAL POPLITEAL ARTERY. A CONTRALATERAL APPROACH WAS USED AND THE LESIONS WERE PREPARED USING ATHERECTOMY AND PRE-DILATED USING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON ANGIOPLASTY. THE LESIONS WERE ALSO POST-DILATED USING PTA. THE CLINIC IDENTIFIED A RESTENOSIS OF TREATED SEGMENT (TARGET LESION) EVENT ON (B)(6) 2022 IN THIS PATIENT. IT WAS REPORTED AS "NOT RELATED" TO THE DEVICE OR PROCEDURE BUT DUE TO A WORSENING PRE-EXISTING CONDITION. THE EVENT IS REPORTED AS TARGET LESION RELATED AND REQUIRED PERCUTANEOUS INTERVENTION TO RESOLVE. THE INTERVENTION TOOK PLACE ON THE (B)(6) 2022 AND INCLUDED NON BM3D BARE METAL STENT PLACEMENT, DRUG COATED BALLOON/DRUG ELUTING BALLOON ANGIOPLASTY AND PTA ON THE PROXIMAL THIRD SFA TO DISTAL THIRD SFA SEGMENT. THE INTERVENTION IS REPORTED AS A TARGET LESION REVASCULARISATION (TLR). THE

  Patient problems: Restenosis

  MAUDE report 15796129 ↗
• InjuryAug 10, 2022Adverse 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 ( 7.0 X 100MM STENT) TO TREAT A RESTENOTIC LESION OF THE SFA DISTAL THIRD TO PROXIMAL POPLITEAL ARTERY IN THE RIGHT LEG. A RETROGRADE APPROACH WAS USED AND PRE- AND POST-DILATATION WAS CONDUCTED WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) AND THE LESION WAS PREPARED USING ATHERECTOMY. ON THE (B)(6) 2022, AN EVENT OF RESTENOSIS OF TREATED SEGMENT (TARGET LESION) WAS REPORTED FROM THE SITE. IT WAS REPORTED AS "NOT RELATED" TO THE DEVICE AND "NOT RELATED" TO THE PROCEDURE BUT DUE TO WORSENING PRE-EXISTING CONDITION. IT WAS ALSO REPORTED AS TARGET LESION RELATED. THE PATIENT UNDERWENT ROUTINE DUPLEX ULTRASOUND (DUS) ON (B)(6) 2021 WITH FOLLOW-UP ON (B)(6) 2021. HE WAS EXPERIENCING RECURRENT CLAUDICATION (RUTHERFORD GRADE 4). DUS SHOWED SEVERE IN STENT RESTENOSIS WITHIN PROXIMAL SFA. ALTHOUGH THE PATIENT HAD STENTS FROM PROXIMAL TO DISTAL SFA PRIOR TO ENROLLMENT IN MIMICS 3D USA. DIAGNOSTIC ANGIO ON (B)(6) 2021 SHOWED "MULTIPLE HIGH GRADE STENOSES >90%. THE P1 SEGMENT [PORTION OF TARGET LESION] SHOWED >80% RESTENOSIS. IT L

  Patient problems: Pain; Restenosis

  MAUDE report 15196912 ↗
• InjuryJul 26, 2022Adverse 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 ( 7.0 X 100MM STENT) TO TREAT A DENOVO LESION OF THE SFA MIDDLE THIRD TO SFA DISTAL THIRD ARTERY IN THE LEFT LEG. A CONTRALATERAL APPROACH WAS USED AND PRE-DILATATION AND POST-DILATATION OF THE TARGET LESION WAS CONDUCTED WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA), AND ATHERECTOMY. ON THE (B)(6) 2022, AN EVENT OF RESTENOSIS OF TREATED VESSEL (TARGET VESSEL) WAS REPORTED FROM THE SITE. IT WAS REPORTED AS "NOT RELATED" TO THE DEVICE AND "NOT RELATED" TO THE PROCEDURE BUT DUE TO WORSENING PRE-EXISTING CONDITION. IT WAS ALSO REPORTED AS TARGET LESION RELATED. THE PATIENT OUTCOME IS REPORTED AS "RESOLVED/RECOVERED". IT LED TO A PERCUTANEOUS INTERVENTION AND IT INVOLVED A TARGET LESION REVASCULARISATION, A NEW BIOMIMICS STENT PLACEMENT, BALLOON ANGIOPLASTY AND LASER ATHERECTOMY. THE DEVICE REMAINS IMPLANTED. THIS WAS REVIEWED BY VERYAN ON (B)(6) 2022 AND CONSIDERED TO BE POSSIBLY RELATED TO THE DEVICE AS IT LED TO A TARGET LESION REVASCULARISATION.

  Patient problems: Restenosis

  MAUDE report 15108568 ↗
• InjuryFeb 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS MDR IS RELATED TO MDR # 30116321500-2022-00006. THERE IS NO EVIDENCE TO SUGGEST THAT THE DEVICE CAUSED OR CONTRIBUTED TO THIS EVENT. THE PATIENT WAS TREATED AS PART OF THE (B)(6) STUDY ON (B)(6) 2021. AT INDEX ,THE SUBJECT HAD TWO BIOMIMICS STENTS IMPLANTED, ONE IN THE SFA MIDDLE THIRD OF THE LEFT LEG AND THE OTHER FROM THE SFA DISTAL THIRD TO PROXIMAL POPLITEAL OF THE LEFT LEG. ON (B)(6) 2022, A RESTENOSIS OF TREATED SEGMENT WAS IDENTIFIED IN THE SFA PROXIMAL THIRD TO SFA DISTAL THIRD AND TREATED WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY / STANDARD BALLOON ANGIOPLASTY, LASER/ATHERECTOMY, AND THROMBECTOMY. THE EVENT IS REPORTED AS "DEFINITELY RELATED" TO THE DEVICE AND TARGET LESION RELATED. THE EVENT IS RESOLVED AND PATIENT HAS RECOVERED. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Restenosis

  MAUDE report 13480320 ↗