BioMimics 3D Vascular Stent System 142122-09Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 05391526850442), received between Nov 22, 2021 and May 14, 2024 — classified as 9 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Advance” (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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryMay 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT WAS ORIGINALLY REPORTED ON 06-DEC-22 (MDR NUMBER 3011632-2022-00103). THIS REPORT IS BEING RESUBMITTED TO CORRECT THE MDR MFR REPORT NUMBER AS IT WAS ORIGINALLY REPORTED AS "3011632-2022-00103" AND TO ENABLE SUBMISSION OF A SUPPLEMENTAL REPORT. 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 IN THE SUPERFICIAL FEMORAL ARTERY (SFA) DISTAL THIRD TO PROXIMAL POPLITEAL SEGMENT TO TREAT A DE NOVO LESION IN THE RIGHT LEG. A CONTRALATERAL APPROACH WAS USED AND THE LESION WAS PRE-DILATED USING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON AND PREPARED WITH ATHERECTOMY. THE TARGET LESION WAS ALSO POST-DILATED WITH PTA. THE SITE REPORTED THAT A RIGHT SFA IN-STENT RESTENOSIS WAS NOTED ON DUPLEX ULTRASOUND (DUS) ON (B)(6) 2022. THE PATIENT UNDERWENT PTA/STANDARD BALLOON ANGIOPLASTY, LASER ATHERECTOMY AND NON-BM3D BARE METAL STENT PLACEMENT IN THE RIGHT SFA MIDDLE THIRD TO PROXIMAL POPLITEAL ON (B)(6) 2022. IT WAS REPORTED THAT THE EVENT LED TO TARGET LESION AND TARGET VESSEL REVASCULARISATION. THE EVENT OUTCOME WAS REPORTED AS RESOLVED/RECOVERED. THE SITE REPORTE

  Patient problems: Restenosis

  MAUDE report 19307321 ↗
• MalfunctionNov 15, 2023Material Separation; Stretched; Difficult to Advance; Material Twisted/Bent; Material Separation; Stretched; Difficult to Advance; Material Twisted/Bent

  ON (B)(6) 2023, WHILE USING A 5.0 X 100 MM BIOMIMICS 3D (BM3D) STENT, THE STENT SHAFT KINKED UPON TRYING TO DELIVER THE DEVICE TO THE TARGET LESION. IT WAS CONFIRMED THAT THE ISSUE WAS EXPERIENCED DURING THE ADVANCEMENT OF THE DEVICE. THE DEVICE WAS REMOVED. THERE WAS NO PATIENT IMPACT OR ISSUES REPORTED. A 5.0 X 125 MM BM3D STENT WAS USED TO CONTINUE THE TREATMENT. THE COMPLAINT DEVICE WAS RETURNED FOR ANALYSIS AND THE INVESTIGATION WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18145390 ↗
• InjuryJul 5, 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 5.0 X 100 MM STENT WAS USED TO TREAT A DENOVO LESION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) PROXIMAL THIRD 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). THE SITE IDENTIFIED A RESTENOSIS OF TREATED SEGMENT (TARGET LESION) ON (B)(6) 2023. IT WAS REPORTED AS NOT RELATED TO THE DEVICE OR PROCEDURE BUT DUE TO A WORSENING PRE-EXISTING CONDITION. IT WAS ALSO REPORTED AS TARGET LESION RELATED. THE PATIENT WAS IN FOR FOLLOW-UP AND ULTRASOUND ON (B)(6) 2023, AT THIS FOLLOW-UP HE REPORTED RETURNED CLAUDICATION SYMPTOMS RELATED TO THE TARGET LIMB (LEFT). THE ULTRASOUND SHOWED GREATER THAN 75% IN-STENT STENOSIS OF THE LEFT PROXIMAL SFA. AN ANGIOGRAM WITH LASER ATHERECTOMY AND DRUG COATED/DRUG ELUTING BALLOON (DCB/DEB) ANGIOPLASTY WAS PERFORMED ON (B)(6) 2023 WITH A POSITIVE RESULT. DURING THIS ANGIOGRAM, INTRAVASCULAR ULTRASOUND (IVUS) REVEALED 73.8% STENOSIS IN THE PROXIMAL SFA STENT. AFTE

  Patient problems: Pain; Restenosis

  MAUDE report 17258045 ↗
• 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 THE (B)(6) 2022, THE PATIENT WAS IMPLANTED WITH ONE BIOMIMICS 3D (BM3D) STENT, A 5.0 X 100MM STENT WHICH WAS USED TO TREAT A RESTENOTIC LESION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) DISTAL THIRD TO PROXIMAL POPLITEAL 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 SITE REPORTED THAT ON 09-FEB-23, 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 A DUPLEX ULTRASOUND (DUS) ON THE 09-FEB-23, WHICH SHOWED A 50% TO 75% STENOSIS OF THE DISTAL SFA. THE PATIENT HAD A PERCUTANEOUS INTERVENTION ON (B)(6) 2023 THAT INCLUDED PTA/STANDARD BALLOON ANGIOPLASTY AND LASER ATHERECTOMY. IT WAS REPORTED AS A TARGET LESION REVASCULARISATION (TLR) AND TARGET VESSEL REVASCULARISATION (TVR). THE PATIENT OUTCOME WAS REPORTED AS RESOLVED/RECOVERED AND THE DEVIC

  Patient problems: Restenosis

  MAUDE report 16916435 ↗
• InjuryFeb 20, 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 5.0 X 100MM BIOMIMICS 3D (BM3D) STENT TO TREAT A DENOVO LESION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) DISTAL THIRD TO PROXIMAL POPLITEAL SEGMENT IN THE RIGHT LEG. A CONTRALATERAL APPROACH WAS USED AND THE LESION WAS PREPARED USING ATHERECTOMY AND PRE-DILATED WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). THE TREATED SEGMENT 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 AND NOT RELATED TO THE PROCEDURE BUT DUE TO A WORSENING OF THE PRE-EXISTING CONDITION. IT WAS REPORTED AS TARGET LESION RELATED. THERE WAS AN IN-STENT RESTENOSIS AND SHORT SEGMENT OCCLUSIONS THROUGHOUT THE ENTIRE LENGTH OF THE STENT. ON (B)(6) 2022, THE SFA PROXIMAL THIRD TO THE PROXIMAL POPLITEAL SEGMENT WAS TREATED WITH PTA/STANDARD BALLOON ANGIOPLASTY AND LASER ATHERECTOMY AND THE PATIENT UNDERWENT AN ANGIOGRAM OF THE RIGHT LEG EXTREMITY (RLE), LASER ATHERECTOMY OF THE SFA, ANGIOPLASTY OF THE SFA AND ILIAC ARTERIES, AS WELL AS STENT PLACEMENT IN

  Patient problems: Restenosis

  MAUDE report 16403677 ↗
• InjuryDec 20, 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 THE (B)(6) 2022, THE PATIENT WAS IMPLANTED WITH ONE BIOMIMICS 3D STENT (A 5 X 100MM STENT) TO TREAT A DENOVO LESION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) PROXIMAL THIRD SEGMENT IN THE LEFT LEG. A CONTRALATERAL APPROACH WAS USED AND THE LESION WAS PREPARED USING ATHERECTOMY. THE LESION WAS ALSO POST-DILATED WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). THE SITE REPORTED THAT ON (B)(6) 2022, A RESTENOSIS OF TREATED SEGMENT (TARGET LESION) WAS IDENTIFIED. THE PATIENT WAS HAVING RECURRENT TARGET LIMB CLAUDICATION SYMPTOMS. AN ULTRASOUND ON THE (B)(6) 2022 REVEALED RESTENOSIS WITHIN THE STENTED PORTION OF THE LEFT PROXIMAL SFA. IT WAS REPORTED AS NOT RELATED TO THE DEVICE OR PROCEDURE BUT DUE TO WORSENING OF THE PATIENT'S PRE-EXISTING CONDITION. IT WAS REPORTED AS TARGET LESION RELATED. ANGIOGRAM WITH LASER ATHERECTOMY AND PTA/STANDARD BALLOON ANGIOPLASTY OF THE SFA PROXIMAL THIRD WAS PERFORMED ON (B)(6) 2022. THIS WAS REPORTED AS A TARGET LESION REVASCULARISATION(TLR)/TARGET VESSEL REVASCULARISATION (TVR). THE EVENT WAS REPORTED AS RESOLVED/RECOVERED AND THE DEVICE REMAINS IMPLANTED. THE EVEN

  Patient problems: Pain; Restenosis

  MAUDE report 16015771 ↗
• InjuryDec 6, 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 PATIENT WAS IMPLANTED WITH ONE BIOMIMICS 3D (BM3D) STENT IN THE SUPERFICIAL FEMORAL ARTERY (SFA) DISTAL THIRD TO PROXIMAL POPLITEAL SEGMENT TO TREAT A DE NOVO LESION IN THE RIGHT LEG. A CONTRALATERAL APPROACH WAS USED AND THE LESION WAS PRE-DILATED USING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON AND PREPARED WITH ATHERECTOMY. THE TARGET LESION WAS ALSO POST-DILATED WITH PTA. THE SITE REPORTED THAT A RIGHT SFA IN-STENT RESTENOSIS WAS NOTED ON DUPLEX ULTRASOUND (DUS) ON (B)(6) 2022. THE PATIENT UNDERWENT PTA/STANDARD BALLOON ANGIOPLASTY, LASER ATHERECTOMY AND NON-BM3D BARE METAL STENT PLACEMENT IN THE RIGHT SFA MIDDLE THIRD TO PROXIMAL POPLITEAL ON (B)(6) 2022. IT WAS REPORTED THAT THE EVENT LED TO TARGET LESION AND TARGET VESSEL REVASCULARISATION. THE EVENT OUTCOME WAS REPORTED AS RESOLVED/RECOVERED. THE SITE REPORTED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE OR STUDY PROCEDURE BUT A WORSENING OF THE PATIENT'S PRE-EXISTING CONDITION. THE EVENT WAS REVIEWED BY VERYAN AND CONSIDERED POSSIBLY RELATED TO THE DEVICE ON (B)(6) 2022. IT WAS REPORTED AS TARGET LESION

  Patient problems: Restenosis

  MAUDE report 15925138 ↗
• InjuryJul 21, 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 ( 5.0 X 100MM STENT) TO TREAT A DENOVO LESION OF THE SFA DISTAL THIRD TO PROXIMAL POPLITEAL ARTERY IN THE RIGHT LEG. A CONTALATERAL 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 SEGMENT (TARGET LESION) WAS REPORTED FROM THE SITE. IT WAS REPORTED AS "NOT RELATED" TO THE DEVICE AND "NOT RELATED" TO THE PROCEDURE BUT WORSENING PRE-EXISTING CONDITION. IT WAS ALSO REPORTED AS TARGET LESION RELATED. THE PATIENT OUTCOME IS REPORTED AS "RESOLVED/RECOVERED". IT WAS AN IN-STENT RESTENOSIS AND IT INVOLVED LASER ATHERECTOMY, AND PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). THE EVENT WAS REVIEWED BY VERYAN ON (B)(6) 2022 AND DUE TO THE TARGET LESION RELATEDNESS AND THE INTERVENTION ON THE RESTENOSIS, IT WAS CONSIDERED POSSIBLY RELATED TO THE DEVICE.THE DEVICE REMAINS IMPLANTED.

  Patient problems: Restenosis

  MAUDE report 15073276 ↗
• InjuryApr 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THERE IS NO EVIDENCE TO SUGGEST THAT THIS EVENT IS RELATED TO A DEFICIENCY OF THE DEVICE. THE SUBJECT WAS ENROLLED IN THE (B)(6) REGISTRY STUDY ON (B)(6) 2021. THEY WERE TREATED FOR A DENOVO OCCLUSION OF THE SFA DISTAL THIRD TO PROXIMAL POPLITEAL ARTERY IN THE RIGHT LEG. ONE BIOMIMICS 3D STENT WAS IMPLANTED. ON (B)(6) 2022, THE SUBJECT PRESENTED AT THE CLINIC WITH RECURRENT CLAUDICATION SYMPTOMS AND REST PAIN IN THE TARGET LEG. AN ULTRASOUND WAS DONE ON (B)(6) 2022 WHICH SHOWED REOCCLUSION OF THE TARGET VESSEL IN THE RIGHT FEMORAL AND POPLITEAL ARTERIES POST ATTEMPTED THROMBECTOMY OF OCCLUDED VESSELS AND STENTING OF OCCLUDED VESSELS. THE SUBJECT HAD A REVASCULARIZATION USING A VEIN GRAFT BYPASS FROM FEMORAL TO ANTERIOR TIBIAL ARTERY USING LEFT GREAT SAPHENOUS VEIN ON (B)(6) 2022. THE SUBJECT REMAINED IN HOSPITAL DUE TO PAIN WITH AMBULATION POST SURGERY AND REQUIRED PHYSICAL THERAPY. THE PATIENT WAS THEN DISCHARGED IN STABLE CONDITION ON (B)(6) 2022. THE DEVICE REMAINS IMPLANTED. THE EVENT IS RESOLVED AND THE PATIENT HAS RECOVERED.

  Patient problems: Obstruction/Occlusion; Pain

  MAUDE report 14043464 ↗
• InjuryMar 16, 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 (B)(6) REGISTRY STUDY ON (B)(6) 2021. AT INDEX PROCEDURE THE PATIENT WAS TREATED FOR A DENOVO OCCLUSION OF THE SFA DISTAL THIRD TO PROXIMAL POPLITEAL ARTERY OF THE RIGHT LEG. ONE BIOMIMICS 3D STENT WAS IMPLANTED. ON (B)(6) 2022 A THROMBOTIC OCCLUSION OF THE SFA MIDDLE THIRD TO PROXIMAL POPLITEAL ARTERY WAS IDENTIFIED WHEN THE PATIENT PRESENTED TO CLINIC WITH RIGHT FOOT REST PAIN/COOLNESS IN THE TARGET LIMB AND WAS TREATED WITH STANDARD BALLOON ANGIOPLASTY/ PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY AND THROMBECTOMY ON (B)(6) 2022 . THE EVENT WAS DESCRIBED AS POSSIBLY RELATED TO THE DEVICE. THIS EVENT IS REPORTED AS BEING TARGET LESION RELATED. THE PATIENT OUTCOME IS DESCRIBED AS "RESOLVED/RECOVERED". THE DEVICE REMAINS IMPLANTED.

  Patient problems: Obstruction/Occlusion; Pain

  MAUDE report 13788259 ↗
• MalfunctionDec 1, 2021Premature Activation; Premature Activation

  ON (B)(6) 2021, A PHYSICIAN AT THE SURGICAL CLINIC OF NASHVILLE WAS ATTEMPTING TO POSITION A BIOMIMICS 3D (5MM X 100MM) IN THE MID SUPERFICIAL FEMORAL ARTERY FOR DEPLOYMENT. THIS WAS A PEDAL ACCESS SITE AND AS THE BIOMIMICS 3D WAS TRAVERSING THE BEND OF THE ANTERIOR TIBIAL VESSEL, THE PHYSICIAN OBSERVED THAT THE STENT BEGAN TO FLOWER IN THE ANTERIOR TIBIAL ORIGIN. THE PHYSICIAN REMOVED THE BIOMIMICS 3D FROM THE PATIENT WITHOUT ISSUE AND WITHOUT DAMAGING THE STENT. HE THEN CHOSE A NON BIOMIMICS STENT WHICH PASSED TO THE SFA LESION AND WAS SUCCESSFULLY DEPLOYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12907176 ↗
• MalfunctionNov 22, 2021Fracture; Material Deformation; Fracture; Material Deformation

  ON (B)(6) 2021, A PHYSICIAN REPORTED TO A VERYAN REPRESENTATIVE INFORMATION ABOUT A STENT FRACTURE IDENTIFIED IN A PATIENT WHO WAS IMPLANTED IN (B)(6) 2021. THE FRACTURE WAS IDENTIFIED DURING A FOLLOW-UP ANGIOGRAM ON (B)(6) 2021. THE VERYAN REPRESENTATIVE RECEIVED ADDITIONAL INFORMATION ON 02 NOVEMBER 2021 STATING THAT ANGIOPLASTY AND PLACEMENT OF ANOTHER STENT INSIDE THE BIOMIMICS WAS PERFORMED. THE STENT REMAINS IMPLANTED. ANGIOGRAPHIC IMAGING IS AVAILABLE. IT IS NOT KNOWN IF THE PHYSICIAN BELIEVES THE INCIDENT IS RELATED TO THE DEVICE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information

  MAUDE report 12851921 ↗