BioMimics 3D Vascular Stent System 142122-13Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 05391526850473), received between Sep 20, 2022 and Jul 11, 2025 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 11, 2025Fracture; Activation Failure; Fracture; Activation Failure

  ON (B)(6) 2025, A PHYSICIAN ATTEMPTED TO TREAT A PATIENT USING A 5X125 MM BIOMIMICS 3D DEVICE. THE TARGET SITE WAS DESCRIBED BY THE PHYSICIAN AS BEING SIGNIFICANTLY DISEASED. THE PHYSICIAN PERFORMED VESSEL PREPARATION VIA BALLOON ANGIOPLASTY AND SHOCKWAVE INTRAVASCULAR LITHOTRIPSY. WHEN AN ATTEMPT WAS MADE TO DEPLOY THE BIOMIMICS 3D DEVICE, IT WAS REPORTED THAT THE STENT WAS UNABLE TO BE DEPLOYED. THE DECISION WAS THEN MADE TO REMOVE THE DEVICE, AND IT WAS REPORTED THAT THE BIOMIMICS 3D STENT WAS THEN BROKEN. FEEDBACK INDICATED THAT THE REMOVAL OF THE DEVICE WAS ULTIMATELY SUCCESSFUL, AND THAT NO PORTION OF THE STENT REMAINED WITHIN THE PATIENT. FEEDBACK ALSO INDICATED THAT THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENTS AS A RESULT OF THIS COMPLAINT THE EVENT WAS CATEGORIZED AS UNABLE TO DEPLOY. THE INITIAL EVENT WAS REPORTED TO VERYAN ON 21-APR-25, BUT IT DID NOT MEET THE MDR REPORTABLE EVENT CRITERIA AT THAT TIME. THE EVENT WAS CATEGORISED AS A POTENTIAL "PARTIAL DEPLOYMENT, WITH STENT FRACTURE " FOLLOWING THE COMPLETION OF THE INVESTIGATION ON 19-JUN-25. THE CAUSE CATEGORY ASSIGNED WAS ANATOMY. THE EVENT WAS NOT RELATED TO A DEFICIENCY OF THE DEVICE. FOLLOWING A REVIEW OF THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22477090 ↗
• InjuryJan 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS RELATED TO MDR NUMBER 3011632150-2023-00147. 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 5.0 X 125 MM BM3D STENT (THE SUBJECT OF THIS REPORT) AND A 6.0 X 60 MM BM3D STENT. THEY WERE USED TO TREAT A DENOVO LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) MIDDLE THIRD TO SFA DISTAL THIRD ARTERY IN THE LEFT 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. ON THE (B)(6) 2023, AN EVENT OF RESTENOSIS OF TREATED SEGMENT (TARGET LESION) WAS IDENTIFIED. IT WAS SITE REPORTED AS POSSIBLY RELATED TO THE DEVICE AND NOT RELATED TO THE PROCEDURE. IT WAS TARGET LESION RELATED. THE PATIENT ATTENDED THE OFFICE ON (B)(6) 2023 COMPLAINING OF SIGNIFICANT SWELLING AND PAIN IN HER LEFT LEG (TARGET LEG). SHE HAD A LEFT LEG EXTREMITY (LLE) ANGIOGRAM ON 19-JUL-23 WHICH SHOWED THAT THE ENTIRE SFA THAT HAD PREVIOUSLY BEEN STENTED HAD SIGNIFICANT STENOSIS THROUGHOUT THE ENTIRE REGION. THE PROXIMAL POPLITEAL SEGMENT ALSO SHOW

  Patient problems: Pain; Restenosis; Swelling/ Edema

  MAUDE report 18495273 ↗
• InjuryJan 25, 2023Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  THIS MDR REPORT IS RELATED TO MDR NUMBER 3011632150-2023-00018. THE PATIENT WAS TREATED AS PART OF THE MIMICS 3D USA POST-MARKET OBSERVATIONAL STUDY. ON (B)(6) 2022, THE PATIENT WAS IMPLANTED WITH TWO BIOMIMICS 3D (BM3D) STENTS, A 5.0 X 125 MM STENT (THE SUBJECT OF THIS REPORT) AND A 6.0 X 60 MM STENT TO TREAT A DENOVO LESION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) MIDDLE THIRD TO 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 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 FOR HER 12-MONTH FOLLOW-UP AND COMPLAINED OF RECURRENT CLAUDICATION IN THE LEFT LOWER EXTREMITY. HER DUPLEX ULTRASOUND (DUS) SHOWED OCCLUSION OF THE STENT WITH AN ANKLE BRACHIAL INDEX (ABI) OF 0.24. SHE HAD AN ANGIOGRAM DONE ON (B)(6) 2023 WHICH SHOWED A CHRONIC APPEARING THROMBUS THROUGHOUT THE LENGTH OF THE STENT. A PTA / STANDARD BALLOON ANGIOPLASTY WAS DONE ON THE EXTERNAL ILIAC AND COMMON FEMORAL ARTERIES AS WELL AS THE ENTIRETY OF THE SFA INCLUDING BO

  Patient problems: Pain; Restenosis

  MAUDE report 16239802 ↗
• InjuryJan 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS RELATED TO MDR REPORT 3011632150-2023-00003. 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 STENTS. ONE A 5.0 X 125MM STENT (THE SUBJECT OF THIS REPORT) AND A 6.0 X 60MM 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 PATIENT WAS COMPLAINING OF RIGHT LEG CLAUDICATION (NON-TARGET LIMB) ON (B)(6) 2022 DURING AN OFFICE VISIT. BILATERAL ANKLE BRACHIAL INDEX MEASUREMENTS (ABI) DECLINED ON (B)(6) 2022. THE PATIENT WAS THEN SCHEDULED FOR A RIGHT LEG ANGIOGRAM ON (B)(6)2022 AND LEFT LEG ANGIOGRAM ON (B)(6) 2022. A LEFT LEG EXTREMITY (LLE) ANGIOGRAM WAS COND

  Patient problems: Pain; Restenosis

  MAUDE report 16172808 ↗
• InjurySep 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 (B)(6) 2021. THE SUBJECT WAS IMPLANTED WITH ONE BIOMIMICS 3D (BM3D) STENT (5.0 X 125MM STENT) TO TREAT A RESTENOTIC LESION OF THE SFA DISTAL THIRD TO PROXIMAL POPLITEAL ARTERY IN THE LEFT LEG. A CONTRALATERAL APPROACH WAS USED AND THE TARGET LESION WAS PREPARED BY PRE-DILATION OF THE TARGET LESION WITH A STANDARD AND DRUG COATED BALLOON ANGIOPLASTY, ATHERECTOMY, CUTTING BALLOON AND THROMBECTOMY. POST-DILATION WAS CONDUCTED WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (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 BUT DUE TO A WORSENING PRE-EXISTING CONDITION. IT WAS ALSO REPORTED AS TARGET LESION RELATED. IT LED TO A PERCUTANEOUS INTERVENTION AND IT INVOLVED A TARGET LESION REVASCULARISATION ON (B)(6) 2022 WITH PTA BALLOON ANGIOPLASTY, DRUG COATED BALLOON ANGIOPLASTY THROMBECTOMY AND LASER ATHERECTOMY. THE DEVICE REMAINS IMPLANTED. THE PATIENT OUTCOME IS REPORTED AS "RESOLVED/RECOVERED". THE EVENT WAS REVIEWED ON 22-AUG-22 AND CONSIDERED POSSIBLY RELAT

  Patient problems: Restenosis

  MAUDE report 15455676 ↗