BioMimics 3D Vascular Stent System 142122-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 05391526850497), received between Feb 25, 2022 and Jul 27, 2023 — classified as 10 injuries.

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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS RELATED TO MDR NUMBER (B)(4). 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 TWO BIOMIMICS 3D (BM3D) STENTS IN THE LEFT LEG, A 7.0 X 125 MM STENT (THE SUBJECT OF THIS REPORT) WHICH WAS USED TO TREAT A DENOVO LESION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) MIDDLE THIRD TO PROXIMAL POPLITEAL SEGMENT AND A 7.0 X 60 MM STENT WHICH WAS USED TO TREAT A DENOVO LESION OF THE SFA PROXIMAL THIRD SEGMENT. A CONTRALATERAL APPROACH WAS USED AND THE LESION WAS PREPARED USING PRE-DILATION WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON. 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 POSSIBLY RELATED TO THE DEVICE AND NOT RELATED TO THE PROCEDURE. IT WAS ALSO REPORTED AS TARGET LESION RELATED. THE PATIENT HAD A COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) OF THE ABDOMINAL AORTA AND BILATERAL LOWER EXTREMITY RUNOFF ON (B)(6) 2022 WHICH SHOWED THAT THE LEFT LOWER EXTREMITY (LLE) SFA WAS OCCLUDED AT THE OSTIUM INCLUDING OCCLUSION OF THE TWO BM3D STENTS. THE PATIENT RETURNED FOR AN OFFICE VISIT O

  Patient problems: Restenosis

  MAUDE report 17406559 ↗
• InjuryMar 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) 2022, THE PATIENT WAS IMPLANTED WITH ONE BIOMIMICS 3D (BM3D) STENT (A 7.0 X 125MM STENT) TO TREAT A DENOVO LESION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) PROXIMAL THIRD IN THE RIGHT LEG. A CONTRALATERAL APPROACH WAS USED AND THE LESION WAS PRE-DILATED WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) AND ATHERECTOMY. THE TREATED SEGMENT WAS POST-DILATED WITH PTA. THE SITE REPORTED THAT ON (B)(6) 2023, A RESTENOSIS OF TREATED SEGMENT (TARGET LESION) WAS IDENTIFIED. THE PATIENT WAS SEEN IN THE CLINICAL OFFICE ON (B)(6) 2023 WITH SOME RIGHT LEG DISCOMFORT. DUPLEX ULTRASOUND (DUS) SHOWED HIGH-GRADE VELOCITIES IN PROXIMAL AND MID SFA WITH SIGNIFICANT DROPPING FLOWS DISTAL TO THIS AND DECREASING ANKLE BRACHIAL INDEXES (ABIS). A RIGHT LEG ANGIOGRAM WAS CONDUCTED ON (B)(6) 2023. THE EVENT WAS SUCCESSFULLY TREATED WITH MEDICATION AND PERCUTANEOUS INTERVENTION, WHICH INVOLVED A PTA / STANDARD BALLOON ANGIOPLASTY OF THE SFA PROXIMAL THIRD AND ANTERIOR TIBIAL ARTERY ON(B)(6) 2023 WITH GOOD RESULTS. IT WAS REPORTED AS A TARGET LESION REVASCULARISATION (TLR) / TARGET VESSEL REVASCULARISATION (TVR).

  Patient problems: Discomfort; Restenosis

  MAUDE report 16479206 ↗
• InjuryJan 16, 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 STENT (A 7.0 X 125MM STENT) TO TREAT A DENOVO LESION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) MIDDLE THIRD TO SFA DISTAL THIRD 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. 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 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) 2022 AND CONSISTED OF A NON BM3D BARE METAL STENT, PTA/STANDARD BALLOON ANGIOPLASTY, LASER ATHERECTOMY AND DRUG COATED BALLOON / DRUG ELUTING BALLOON OF THE SFA PROXIMAL THIRD TO MIDDLE THIRD SEGMENT. THIS WAS REPORTED AS A TARGET LESION REVASCULARISATION (TLR)/TARGET VESSEL REVASCULARISATION (TVR). THIS EVENT WAS REVIEWED BY VERYAN ON 19-DEC-22 AND CONSIDERED POSSIBLY RELATED TO THE DEVICE. THE PAT

  Patient problems: Restenosis

  MAUDE report 16172819 ↗
• InjuryDec 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS RELATED TO MDR REPORT NUMBER 3011632150-2022-00122. THE PATIENT WAS TREATED AS PART OF THE MIMICS 3D USA POST-MARKET OBSERVATIONAL STUDY. ON (B)(6) 2022, THE PATIENT WAS TREATED WITH TWO BIOMIMICS 3D (BM3D) STENTS TO TREAT DENOVO LESIONS OF THE SUPERFICIAL FEMORAL ARTERY (SFA) OSTIAL TO PROXIMAL THIRD (A 7.0 X 125MM STENT - THE SUBJECT OF THIS REPORT) AND SFA MIDDLE THIRD TO DISTAL THIRD ( A 7.0 X 150MM STENT) IN THE LEFT LEG. A CONTRALATERAL APPROACH WAS USED AND THE LESIONS WERE PREPARED USING ATHERECTOMY AND PRE-DILATED WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). THE LESIONS WERE ALSO POST-DILATED WITH PTA. THE SITE REPORTED THAT ON (B)(6) 2022, A RESTENOSIS OF THE TREATED SEGMENT (TARGET LESION) WAS IDENTIFIED. THE PATIENT UNDERWENT LEFT LEG EXTREMITY (LLE) ANGIOGRAM WITH LASER ATHERECTOMY AND PTA/STANDARD BALLOON ANGIOPLASTY OF THE LEFT SFA PROXIMAL THIRD TO PROXIMAL POPLITEAL ARTERIAL SEGMENT FOR STENT OCCLUSION WITHOUT RESOLUTION. PATIENT WAS REFERRED FOR LLE BYPASS. IT WAS REPORTED AS A TARGET LESION REVASCULARISATION/TARGET VESSEL REVASCULARISATION (TLR/TVR). THE RESTENOSIS EVENT WAS REPORTED AS NOT RELATED TO THE DEVICE OR PROCEDURE BUT DUE TO A WORSENING OF

  Patient problems: Obstruction/Occlusion; Restenosis

  MAUDE report 15978997 ↗
• InjuryAug 5, 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 125MM STENT) TO TREAT A DENOVO LESION OF THE SFA DISTAL THIRD ARTERY IN THE LEFT LEG. A RETROGRADE APPROACH WAS USED AND PRE-DILATATION AND POST-DILATATION OF THE TARGET LESION WAS CONDUCTED WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WERE USED. ON THE (B)(6) 2022, AN EVENT OF CHRONIC NEUROPATHY WAS REPORTED FROM THE SITE. IT WAS REPORTED AS "NOT RELATED " TO THE DEVICE AND "NOT RELATED" TO THE PROCEDURE BUT DUE TO INTERCURRENT INTERVENTION. 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 VESSEL REVASCULARISATION ON SFA MIDDLE THIRD TO PROXIMAL POPLITEAL ON (B)(6) 2022 WITH IVUS EVALUATION, BALLOON ANGIOPLASTY (PTA) OF LEFT DISTAL PTA, LASER ATHERECTOMY AND TWO STENT PLACEMENTS IN THE SFA MIDDLE AND P3 SEGMENT OF THE POPLITEAL ARTERY.THE SITE REPORTS THAT "PER SOURCE DOCUMENTS AND IMAGING FROM (B)(6) 2022, NO SIGNIFICANT DEEP VEIN INSUFFICIENCY NOTED AND ARE PATENT, CLINICAL RESOLVED. HOWEVER,

  Patient problems: Neuropathy; Pain; Restenosis; Swelling/ Edema

  MAUDE report 15174992 ↗
• InjuryJul 28, 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) 2022. THE SUBJECT WAS IMPLANTED WITH ONE BIOMIMICS 3D (BM3D) STENT ( 7.0 X 125MM STENT) TO TREAT A DENOVO LESION OF THE SFA MIDDLE THIRD TO PROXIMAL POPLITEAL ARTERY IN THE LEFT LEG. A RETROGRADE APPROACH WAS USED AND PRE-DILATATION AND POST-DILATATION OF THE TARGET LESION WAS CONDUCTED WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA), AND ATHERECTOMY WERE USED. ON (B)(6) 2022, AN EVENT OF RESTENOSIS OF TREATED SEGMENT (TARGET LESION) WAS REPORTED FROM THE SITE. IT WAS REPORTED AS "POSSIBLY 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 ON (B)(6) 2022 WITH BALLOON ANGIOPLASTY. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Restenosis

  MAUDE report 15125572 ↗
• InjuryJul 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS MDR REPORT IS RELATED TO MDR REPORT NUMBERS 3011632150-2022-00045 AND 3011632150-2022-00046. THE PATIENT WAS TREATED AS PART OF THE MIMICS 3D USA POST-MARKET OBSERVATIONAL STUDY ON (B)(6) 2021. THE SUBJECT WAS IMPLANTED WITH THREE BIOMIMICS 3D STENTS (A 7.0 X 150MM AND TWO 7.0 X 125 MM STENTS, ONE WHICH RELATES TO THIS REPORT) TO TREAT A DENOVO LESION OF THE SFA OSTIAL 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). ATHERECTOMY WAS ALSO PERFORMED PRE STENT PLACEMENT. 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 OR PROCEDURE BUT TO WORSENING PRE-EXISTING CONDITION. IT WAS ALSO REPORTED AS TARGET LESION RELATED. THE PATIENT OUTCOME IS REPORTED AS "RESOLVED/RECOVERED". ON REVIEW OF THE EVENT BY VERYAN ON (B)(6) 2022, IT WAS DETERMINED TO BE POSSIBLY RELATED TO THE DEVICE AS IT LED TO A TARGET LESION REVASCULARISATION AND IT INVOLVED LASER ATHERECTOMY. THIS INTERVENTION TOOK PLACE ON (B)(6) 2022. THE DEVICE REMAINS IMPLANTED

  Patient problems: Obstruction/Occlusion; Pain; Restenosis

  MAUDE report 14987630 ↗
• InjuryJul 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS MDR REPORT IS RELATED TO MDR REPORT NUMBERS 3011632150-2022-00045 AND 3011632150-2022-00047. THE PATIENT WAS TREATED AS PART OF THE MIMICS 3D USA POST-MARKET OBSERVATIONAL STUDY ON (B)(6) 2021. THE SUBJECT WAS IMPLANTED WITH THREE BIOMIMICS 3D STENTS (A 7.0 X 150MM AND TWO 7.0 X 125 MM STENTS, ONE WHICH RELATES TO THIS REPORT) TO TREAT A DENOVO LESION OF THE SFA OSTIAL 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). ATHERECTOMY WAS ALSO PERFORMED PRE STENT PLACEMENT. 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 OR PROCEDURE BUT TO WORSENING PRE-EXISTING CONDITION. IT WAS ALSO REPORTED AS TARGET LESION RELATED. THE PATIENT OUTCOME IS REPORTED AS "RESOLVED/RECOVERED". ON REVIEW OF THE EVENT BY VERYAN ON (B)(6) 2022, IT WAS DETERMINED TO BE POSSIBLY RELATED TO THE DEVICE AS IT LED TO A TARGET LESION REVASCULARISATION AND IT INVOLVED LASER ATHERECTOMY. THIS INTERVENTION TOOK PLACE ON (B)(6) 2022. THE DEVICE REMAINS IMPLANTED

  Patient problems: Obstruction/Occlusion; Pain; Restenosis

  MAUDE report 14987590 ↗
• InjuryJun 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS MDR IS RELATED TO 3011632150-2022-00029. THE PATIENT WAS TREATED AS PART OF THE MIMICS 3D USA POST-MARKET OBSERVATIONAL STUDY ON (B)(6) 2021. THE SUBJECT WAS IMPLANTED WITH TWO BIOMIMICS-3D STENTS (A 7.0 X 150MM AND A 7.0 X 125MM) TO TREAT A DENOVO LESION OF THE SFA PROXIMAL THIRD TO SFA MIDDLE THIRD OF THE RIGHT LEG. A RETROGRADE APPROACH WAS USED AND PRE-DILATATION AND POST-DILATATION OF THE TARGET LESION WAS CONDUCTED WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. ATHERECTOMY WAS ALSO PERFORMED PRE-STENT PLACEMENT. ON (B)(6) 2022, AN EVENT OF OCCLUSION WAS REPORTED FROM THE SITE. IT WAS REPORTED AS "NOT RELATED" TO THE DEVICE OR PROCEDURE BUT TO A WORSENING OF THE PRE-EXISTING CONDITION. IT WAS REPORTED AS TARGET LESION RELATED. IT WAS IDENTIFIED AT 12-MONTH ULTRASOUND BUT AN ANGIOGRAM ON (B)(6) 2022 SHOWED OCCLUSION OF THE PROXIMAL TO MIDDLE SEGMENT OF THE BIOMIMICS STENT. THE SITE IS CONSIDERING SURGICAL VERSUS PERCUTANEOUS INTERVENTION. THE EVENT IS REPORTED AS SERIOUS. THE PATIENT OUTCOME IS DESCRIBED AS "CONTINUING". THE DEVICE REMAINS IMPLANTED. ON REVIEW OF THE EVENT BY VERYAN, IT WAS DETERMINED TO BE POSSIBLY RELATED TO THE DEVICE DUE TO THE TARGET LESION RELATIONSHIP.

  Patient problems: Obstruction/Occlusion

  MAUDE report 14562384 ↗
• InjuryFeb 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THERE IS NO EVIDENCE TO SUGGEST THAT THE DEVICE CAUSED OR CONTRIBUTED TO THIS EVENT. THE PATIENT WAS TREATED AS PART OF THE MIMICS 3D USA POST-MARKET OBSERVATIONAL STUDY ON (B)(6) 2021 TO TREAT A DENOVO OCCLUSION IN THE SFA PROXIMAL THIRD TO SFA MIDDLE THIRD OF THE LEFT LEG. AN EVENT OF RESTENOSIS OF TREATED SEGMENT (TARGET LESION) WAS ORIGINALLY REPORTED TO VERYAN ON 04 FEB 2022 AS "NOT RELATED" TO THE DEVICE OR PROCEDURE. IT WAS REPORTED WITH THE FOLLOWING COMMENT "SUBJECT HAD COMPLAINTS OF RECURRENT SEVERE CLAUDICATION SYMPTOMS OF BILATERAL LOWER EXTREMITY WITH MILD REST PAIN AND SEVERE CALF CLAUDICATION. ANGIOGRAM SHOWED 80% IN-STENT RESTENOSIS." THE EVENT WAS REVIEWED INTERNALLY AT A VERYAN SAFETY REVIEW MEETING ON 07 FEB 2022 AND CONFIRMED BY VERYAN'S CHIEF MEDICAL OFFICER THAT BASED ON THE IN-STENT RESTENOSIS, IT IS POSSIBLY DEVICE-RELATED. THE OUTCOME OF THE EVENT IS REPORTED AS RESOLVED/RECOVERED. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Restenosis

  MAUDE report 13598166 ↗