BioMimics 3D Vascular Stent System 142122-05Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05391526850411), received between Sep 21, 2022 and Dec 6, 2022 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• 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 5.0 X 80MM 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 PREDILATED 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 POPLITEAL IN-STENT RESTENOSIS WAS NOTED ON DUPLEX ULTRASOUND (DUS) ON (B)(6) 2022. A RIGHT LEG WOUND WAS SLOW TO HEAL. THE PATIENT UNDERWENT ANGIOGRAM AND PTA/STANDARD BALLOON ANGIOPLASTY AND LASER ATHERECTOMY IN THE RIGHT SFA TO POPLITEAL ARTERY 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

  Patient problems: Restenosis

  MAUDE report 15925105 ↗
• InjurySep 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 80 MM STENT) TO TREAT A DENOVO LESION OF THE SFA DISTAL THIRD TO PROXIMAL POPLITEAL IN THE RIGHT LEG. A CONTRALATERAL APPROACH WAS USED AND THE TARGET LESION WAS PREPARED BY PRE-DILATION OF THE TARGET LESION WITH A STANDARD BALLOON PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY AND POST DILATED WITH PTA. ON THE (B)(6) 2022, AN EVENT OF RESTENOSIS OF TREATED VESSEL (TARGET VESSEL) WAS REPORTED FROM THE SITE. IT WAS REPORTED AS "POSSIBLY RELATED" TO THE DEVICE AND "DEFINITELY RELATED" TO THE PROCEDURE. IT WAS ALSO REPORTED AS TARGET LESION RELATED. IT LED TO A PERCUTANEOUS INTERVENTION AND IT INVOLVED A TARGET LESION REVASCULARISATION AND UNDERWENT UNCOMPLICATED ANGIOPLASTY OF RIGHT SUPERFICIAL ARTERY WITH DRUG COATED BALLOON AND STANDARD BALLOON ANGIOPLASTY . THE DEVICE REMAINS IMPLANTED. THE PATIENT OUTCOME IS REPORTED AS "RESOLVED/RECOVERED". THE EVENT WAS REVIEWED ON (B)(6) 2022 AND CONSIDERED POSSIBLY RELATED TO THE DEVICE.

  Patient problems: Hematoma; Pain; Restenosis

  MAUDE report 15460719 ↗