BioMimics 3D Vascular Stent System 142122-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 05391526850381), received between Aug 10, 2022 and Apr 29, 2024 — classified as 9 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryApr 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS ENROLLED IN THE MIMICS 3D USA POST-MARKET OBSERVATIONAL STUDY. ON (B)(6) 2022, THE PATIENT WAS IMPLANTED WITH TWO BIOMIMICS 3D (BM3D) STUDY STENTS, A 6.0 X 60 MM STENT TO TREAT A DENOVO LESION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) PROXIMAL THIRD TO SFA MIDDLE THIRD SEGMENT AND A 6.0 X 100 MM BM3D STENT WAS USED TO TREAT A DENOVO LESION IN THE RIGHT SFA MIDDLE THIRD TO SFA DISTAL THIRD SEGMENT. A RETROGRADE APPROACH WAS USED AND THE LESIONS WERE PREPARED USING PRE-DILATION WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) AND ATHERECTOMY. THE TREATED SEGMENTS WERE POST-DILATED WITH PTA. ON (B)(6) 2022, A RESTENOSIS OF THE TREATED SEGMENT (TARGET LESION) WAS IDENTIFIED BY THE SITE. THIS WAS REPORTED AS POSSIBLY RELATED TO THE STUDY DEVICES AND NOT RELATED TO THE PROCEDURE. IT WAS TREATED WITH A TARGET LESION/VESSEL REVASCULARISATION (TLR/TVR). THIS EVENT WAS REPORTED AS MDR REPORTS 3011632150-2022-00096 AND 2011632150-2022-00097. ON (B)(6) 2023, A SECOND RESTENOSIS OF TREATED SEGMENT (TARGET LESION) WAS IDENTIFIED. IT WAS REPORTED AS POSSIBLY RELATED TO THE STUDY DEVICES AND NOT PROCEDURE-RELATED. IT WAS TREATED WITH A TLR/TVR INTERVENTION ON (B)(6) 2023. THIS

  Patient problems: Pain; Restenosis

  MAUDE report 19199927 ↗
• InjuryApr 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS ENROLLED IN THE MIMICS 3D USA POST-MARKET OBSERVATIONAL STUDY. ON (B)(6) 2022, THE PATIENT WAS IMPLANTED WITH ONE BIOMIMICS 3D (BM3D) 5.0 X 60 MM STENT TO TREAT A DENOVO LESION IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA) DISTAL THIRD. A RETROGRADE APPROACH WAS USED AND THE LESION WAS STENTED AND POST-DILATED WITH A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON. ON (B)(6) 2023, A RESTENOSIS OF THE TREATED SEGMENT (TARGET LESION) WAS IDENTIFIED AND IT WAS REPORTED AS POSSIBLY RELATED TO THE DEVICE AND NOT RELATED TO THE PROCEDURE. IT WAS TARGET LESION-RELATED. IT WAS IDENTIFIED AT THE PATIENT'S 12-MONTH FOLLOW-UP VISIT. THE PATIENT WAS EXPERIENCING RUTHERFORD CLASS (RC) 3 SYMPTOMS IN THE LEFT LEG. DUPLEX ULTRASOUND (DUS) SHOWED STENOSIS IN THE LEFT DISTAL SFA (TARGET LESION). A DIAGNOSTIC ANGIO ON (B)(6) 2023 SHOWED SEVERE IN-STENT RESTENOSIS AT (B)(4). AN INTERVENTION WAS PERFORMED ON (B)(6) 2023. A LASER ATHERECTOMY WAS PERFORMED WITHIN THE EXISTING STENT, FOLLOWED BY DRUG COATED/ELUTING BALLOON (DCB/DEB). RESIDUAL STENOSIS WAS LESS THAN (B)(4) AFTERWARDS. THE INTERVENTION WAS A TARGET LESION/VESSEL REVASCULARISATION (TLR/TVR). THE OUTCOME WAS REPORTED AS RES

  Patient problems: Pain; Restenosis

  MAUDE report 19069142 ↗
• InjuryJan 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS RELATED TO MDR REPORT 3011632150-2023-00151. 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 BIOMIMICS 3D (BM3D) STENTS IN THE RIGHT LEG, A 5.0 X 150 MM STENT WHICH WAS USED TO TREAT A RESTENOTIC LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) PROXIMAL THIRD TO SFA MIDDLE THIRD AND A 5.0 X 60 MM STENT (THE SUBJECT OF THIS REPORT) WHICH WAS USED TO TREAT A DENOVO LESION IN THE SFA MIDDLE THIRD TO SFA DISTAL THIRD. AN ANTEGRADE APPROACH WAS USED AND THE LESION WAS PREPARED USING PRE-DILATION WITH A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON. THE TREATED SEGMENT WAS POST-DILATED WITH PTA. THE SITE IDENTIFIED A RESTENOSIS OF TREATED SEGMENT (TARGET LESION) EVENT ON (B)(6) 2023. IT WAS REPORTED AS POSSIBLY RELATED TO THE DEVICE AND NOT RELATED TO THE PROCEDURE. IT WAS TARGET LESION RELATED. THE PATIENT CAME INTO THE OFFICE ON (B)(6) 2023 FOR HER 24-MONTH STUDY VISIT COMPLAINING OF ISCHEMIC REST PAIN IN HER RIGHT LEG (TARGET LEG). AN ULTRASOUND SHOWED AN OCCLUSION IN THE DISTAL PART OF HER STENT. SHE HAD AN ANGIOGRAM ON HER RIGHT LEG ON (B)(6) 2023 WHICH CONFIRMED AN OCCLUSION IN THE

  Patient problems: Ischemia; Pain; Restenosis

  MAUDE report 18533217 ↗
• InjurySep 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS RELATED TO MDR REPORT 3011632150-2023-00113. 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 IN THE RIGHT LEG, A 5.0 X 150 MM STENT WHICH WAS USED TO TREAT A RESTENOTIC LESION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) PROXIMAL THIRD TO MIDDLE THIRD AND A 5.0 X 60 MM STENT (THE SUBJECT OF THIS REPORT) TO TREAT A RESTENOTIC LESION IN THE SFA MIDDLE THIRD TO DISTAL THIRD. AN ANTEGRADE APPROACH WAS USED AND THE LESIONS WERE PREPARED USING PRE-DILATION WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). THE TREATED SEGMENTS WERE POST-DILATED WITH PTA. ON (B)(6) 2023, THE SITE IDENTIFIED A RESTENOSIS OF TREATED SEGMENT (TARGET LESION). IT WAS REPORTED AS POSSIBLY RELATED TO THE DEVICE AND NOT RELATED TO THE PROCEDURE. IT WAS TARGET LESION RELATED. THE PATIENT WAS SEEN IN THE OFFICE ON (B)(6) 2023 FOR RIGHT FOOT PAIN AND DISCOLORATION. DUPLEX ULTRASOUND (DUS) CONFIRMED A RIGHT SFA STENT OCCLUSION WITH RECONSTITUTION OF THE POPLITEAL AT THE KNEE LEVEL. A RIGHT LEG ANGIOGRAM WAS THEN SCHEDULED AND COMPLETED ON (B)(6) 2023. THE ANGIOGRAM SHOWED THAT THERE WERE AREAS OF

  Patient problems: Pain; Restenosis; Skin Discoloration

  MAUDE report 17688746 ↗
• InjuryAug 2, 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 IN THE LEFT LEG, A 5.0 X 60 MM STENT WHICH WAS USED TO TREAT A RESTENOTIC LESION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) PROXIMAL THIRD TO MIDDLE THIRD SEGMENT. 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. 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 WAS DUE TO A WORSENING PRE-EXISTING CONDITION. IT WAS ALSO REPORTED AS TARGET LESION RELATED. THE PATIENT HAD INCREASING CLAUDICATION WITH CRAMPING OF THE CALF MUSCLES AFTER WALKING 50 TO 100 YARDS. THERE WAS GREATER THAN 75% STENOSIS IN THE LEFT PROXIMAL SFA. ON (B)(6) 2023, THE SFA PROXIMAL THIRD TO MIDDLE THIRD WAS TREATED WITH PTA / STANDARD BALLOON ANGIOPLASTY, AND LASER/ATHERECTOMY. IT WAS REPORTED AS A TARGET LESION/VESSEL REVASCULARISATION (TLR/TVR). THE OUTCOME WAS REPORTED AS RESOLVED/RECOVERED. THE DEVICE REMAIN

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

  MAUDE report 17443394 ↗
• 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) 2021, THE PATIENT WAS IMPLANTED WITH ONE BIOMIMICS 3D (BM3D) STENT, A 5.0 X 60 MM STENT WHICH WAS USED TO TREAT A DENOVO LESION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) MIDDLE 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 POST-DILATED WITH PTA. THE SITE IDENTIFIED A RESTENOSIS OF TREATED SEGMENT (TARGET LESION) ON (B)(6) 2023. IT WAS REPORTED AS POSSIBLY RELATED TO THE DEVICE AND NOT RELATED TO THE PROCEDURE. IT WAS ALSO REPORTED AS TARGET LESION RELATED. AN INTERVENTION ON (B)(6) 2023 CONDUCTED ON THE SFA MIDDLE THIRD INCLUDED DRUG COATED BALLOON / DRUG ELUTING BALLOON (DCB/DEB) AND LASER/ATHERECTOMY. THE INTERVENTION WAS REPORTED AS A TARGET LESION/VESSEL REVASCULARISATION (TLR/TVR). THE OUTCOME WAS REPORTED AS RESOLVED/RECOVERED. THE DEVICE REMAINS IMPLANTED.

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

  MAUDE report 17256859 ↗
• InjuryJan 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS MDR REPORT IS RELATED TO MDR NUMBER 3011632150-2023-00013. 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 (A 5.0 X 150MM STENT AND A 5.0 X 60MM STENT - THE SUBJECT OF THIS REPORT ) TO TREAT A DENOVO LESION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) PROXIMAL THIRD TO MIDDLE THIRD SEGMENT AND MIDDLE THIRD TO DISTAL THIRD SEGMENTS IN THE RIGHT LEG. AN ANTEGRADE APPROACH WAS USED AND THE LESION WAS 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. THE PATIENT WAS SEEN IN THE EMERGENCY DEPARTMENT (ED) ON 19-DEC-22 FOR RIGHT FOOT PAIN WHICH BEGAN THE PREVIOUS DAY AND THERE WAS NO PULSE IN THE RIGHT FOOT AND ANKLE. IT WAS DIAGNOSED AS ACUTE ON CHRONIC ISCHEMIA OF THE RIGHT FOOT. THE PATIENT WAS STARTED ON HEPARIN AND TRANSFERRED TO A DIFFERENT HOSPITAL (CAPE COD HOSPITAL). THE PATIENT WAS ADMITTED BETWEEN THE (B)(6) 2022 AND THE (B)(6) 2022. THE EVENT WAS TREATED SUCCESSFULLY WITH MEDICATION, A NON BM3D BARE

  Patient problems: Ischemia; Pain; Restenosis

  MAUDE report 16264109 ↗
• InjuryOct 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS RELATED TO MDR NUMBER 3011632150-2022-00090. 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 (BM3D) STENTS (ONE 5.0 X 150MM STENT TO TREAT A DENOVO LESION OF THE SFA PROXIMAL THIRD TO MIDDLE THIRD AND A 5.0 X 60MM STENT (THE SUBJECT OF THIS REPORT) TO TREAT A DENOVO LESION OF THE SFA MIDDLE TO DISTAL THIRD) IN THE RIGHT LEG. AN ANTEGRADE APPROACH WAS USED AND THE TARGET LESION WAS PREPARED BY PRE-DILATION WITH A STANDARD PERCUTANEOUS BALLOON ANGIOPLASTY (PTA) AND DRUG COATED BALLOON ANGIOPLASTY. POST-DILATION WAS CONDUCTED WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). THE PATIENT ATTENDED CLINIC ON (B)(6) 2022 FOR RECURRENT CLAUDICATION AND AN ULTRASOUND REVEALED THAT THE STENT HAD A STENOSIS AT THE DISTAL ASPECT OF THE RIGHT SFA. AN ANGIOGRAM WAS DONE ON (B)(6) 2022 WHICH SHOWED A PATENT PROXIMAL SFA BUT STARTING JUST INSIDE THE PROXIMAL PORTION OF THE FIRST STENT THERE WERE NOTED TO BE STENOSIS PRESENT. AS THE CONTRAST WENT FURTHER, THERE WERE MULTIPLE TANDEM STENOSIS PRESENT WITHIN THE SUPERFICIAL FEMORAL ARTERY INSIDE THE STENTS. JUST BEYOND THE STENTS THERE WAS AN O

  Patient problems: Pain; Restenosis

  MAUDE report 15556155 ↗
• 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 ( 5.0 X 60MM STENT) TO TREAT A DENOVO LESION OF THE SFA MIDDLE THIRD IN THE RIGHT LEG. A CONTRALATERAL APPROACH WAS USED AND PRE-DILATATION WAS CONDUCTED WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA), AND ATHERECTOMY WERE USED TO PREPARE THE LESION WHILE POST-DILATION WAS ALSO CONDUCTED USING PTA. 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. 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 PTA BALLOON ANGIOPLASTY AND LASER ATHERECTOMY. THE DEVICE REMAINS IMPLANTED. THIS WAS REVIEWED BY VERYAN ON (B)(6) 2022 AND CONSIDERED POSSIBLY RELATED TO THE DEVICE. THE SITE SUBSEQUENTLY UPDATED THE DEVICE RELATIONSHIP TO "POSSIBLY RELATED" ON (B)(6) 2022.

  Patient problems: Restenosis

  MAUDE report 15196909 ↗