BioMimics 3D Vascular Stent System 142122-07Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 05391526850435), received between Jun 1, 2022 and Jan 3, 2025 — classified as 9 injuries, 1 malfunction.

The most frequently reported specific device problem is “Activation Failure” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 3, 2025Activation, Positioning or Separation Problem; Activation Failure; Activation, Positioning or Separation Problem; Activation Failure

  ON (B)(6)2024, A PHYSICIAN WAS USING A BIOMIMICS 3D (BM3D) 7.0 X 80 MM DEVICE TO TREAT A PATIENT. IT WAS REPORTED THAT THE STENT WAS PARTIALLY DEPLOYED PRIOR TO INTRODUCING IT ON THE GUIDEWIRE. THE PHYSICIAN REPORTED THAT THEY WERE UNCERTAIN IF THE EVENT RELATED TO THE DEVICE. THERE WAS NO IMPACT TO THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21065161 ↗
• InjurySep 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS RELATED TO MDR NUMBER 3011632150-2024-00047. THIS PATIENT WAS ENROLLED IN THE MIMICS 3D USA POST-MARKET OBSERVATIONAL REGISTRY STUDY. ON (B)(6) 2021, THE PATIENT WAS IMPLANTED WITH TWO BIOMIMICS 3D (BM3D) STENTS. A 7.0 X 80 MM STENT (THE SUBJECT OF THIS REPORT) AND A 7.0 X 150 MM STENT WAS USED TREAT A DENOVO LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) PROXIMAL THIRD TO SFA MIDDLE THIRD IN THE LEFT LEG. A CONTRALATERAL APPROACH WAS USED AND THE LESION WAS PRE-DILATED WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA), AND AN INPACT DRUG COATED/ELUTING BALLOON (DCB/DEB) AND CUTTING BALLOON WERE USED. THE TREATED SEGMENT WAS POST-DILATED WITH PTA. ON (B)(6) 2022, THE SITE IDENTIFIED AN OCCLUSION. IT WAS REPORTED AS POSSIBLY RELATED TO THE DEVICE BUT NOT RELATED TO THE PROCEDURE. IT REQUIRED PERCUTANEOUS INTERVENTION. IT WAS REPORTED AS TARGET LESION RELATED. THE PATIENT HAD A COMPUTED TOMOGRAPHY (CT) SCAN THAT DEMONSTRATED THE LEFT SFA WAS 100% OCCLUDED. THE PATIENT THEN HAD PERCUTANEOUS INTERVENTION OF THE LEFT SFA PROXIMAL/MIDDLE PORTION, THAT WAS PREVIOUSLY TREATED WITH THE BM3D STENT. THE DISTAL SFA WAS ALSO TREATED. THIS SFA WAS SUCCESSFULLY TREATED WITH ROTAREX

  Patient problems: Obstruction/Occlusion

  MAUDE report 20246038 ↗
• InjuryMay 13, 2024Adverse 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)2 022, THE PATIENT WAS IMPLANTED WITH ONE BIOMIMICS 3D (BM3D) STENT, A 7.0 X 80 MM STENT WAS USED TO TREAT A DENOVO LESION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) MIDDLE THIRD TO SFA DISTAL THIRD IN THE LEFT LEG. A RETROGRADE 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 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 REPORTED AS HAVING A RECURRENCE OF CLAUDICATION STATUS POST-LEFT SFA REVASCULARISATION AND COMMON FEMORAL ARTERY (CFA) ENDARTERECTOMY. THE PATIENT PREVIOUSLY EXPERIENCED AN IMPROVEMENT IN HIS SYMPTOMS BUT AT HIS LAST CLINIC VISIT REPORTED THAT THE CLAUDICATION HAD RETURNED. IMAGING DEMONSTRATED WORSENING LEFT LOWER EXTREMITY (LLE) MULTILEVEL FLOW-LIMITING ARTERIAL DISEASE WITH CLAUDICATION PRESENT WITH EXERCISE ANKLE-BRACHIAL INDEXES (ABIS). MILD

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

  MAUDE report 19305586 ↗
• InjuryMar 15, 2024Adverse 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 PATIENT WAS IMPLANTED WITH ONE BIOMIMICS 3D (BM3D) STENT, ONE 7.0 X 80 MM STENT TO TREAT A DENOVO LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) PROXIMAL THIRD IN THE LEFT LEG. A RETROGRADE 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 05-FEB-24, AN OCCLUSION WAS IDENTIFIED. IT WAS REPORTED AS NOT RELATED TO THE DEVICE OR THE PROCEDURE. IT WAS RELATED TO CONCOMITANT MEDICATION BUT REQUIRED MEDICATION TO TREAT. THE OUTCOME WAS REPORTED AS CONTINUING. THE OCCLUSION WAS IN THE PROXIMAL TO MID ASPECT OF THE LEFT SFA. THE PATIENT'S STATUS WAS REPORTED AS BEING ASYMPTOMATIC FROM AN ARTERIAL STANDPOINT, POST BILATERAL LOWER EXTREMITY REVASCULARISATION (INITIAL PROCEDURE ON (B)(6) 2022). THERE WAS NO CLAUDICATION OR REST PAIN, NO ULCERATIONS AND NO UPCOMING PODIATRIC SURGERY. IMAGING TAKEN ON 05-FEB-24 SHOWED MULTILEVEL FLOW-LIMITING ARTERIAL DISEASE BILATERALLY WITH OCCLUDED SFA ARTERIES BILATERALLY. THERE WERE MILDLY DIMINISHED ANKLE-BRACHIAL

  Patient problems: Obstruction/Occlusion

  MAUDE report 18912009 ↗
• InjuryJul 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS RELATED TO MDR NUMBER 3011632150-2023-00086. 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 7.0 X 150 MM STENT AND A 7.0 X 80 MM STENT (THE SUBJECT OF THIS REPORT) WHICH WERE USED TO TREAT A DENOVO LESION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) MIDDLE THIRD TO PROXIMAL POPLITEAL ARTERY IN THE RIGHT LEG. A RETROGRADE 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) 2022. IT WAS REPORTED AS DEFINITELY RELATED TO THE DEVICE AND NOT RELATED TO THE PROCEDURE. IT WAS ALSO REPORTED AS TARGET LESION RELATED. THE PATIENT HAD A 12-MONTH ANKLE BRACHIAL INDEX (ABI) AND DUPLEX ULTRASOUND (DUS) ON THE (B)(6) 2022. THE ABI ON THE RIGHT WAS MEASURED AT 0.37 (RESTING) AND DUS SHOWED MONOPHASIC WAVEFORMS THROUGHOUT AND ELEVATED VELOCITIES. THE PATIENT WAS EXPERIENCING SYMPTOMS CONSISTENT WITH RUTHERFORD CLASS 3. A DIAGNOSTIC ANGIOGRAM ON (B)(6) 2022 ID

  Patient problems: Pain; Restenosis

  MAUDE report 17279927 ↗
• 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 7.0 X 80 MM STENT WHICH WAS USED TO TREAT A DENOVO LESION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) MIDDLE THIRD TO DISTAL 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) 2022. 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. A RIGHT LEG EXTREMITY (RLE) REVASCULARISATION WAS DONE ON (B)(6) 2022. THE RIGHT SFA, POPLITEAL (POP) AND ANTERIOR TIBIAL (AT) ARTERIES WERE TREATED WITH ORBITAL LASER ATHERECTOMY AND PTA/STANDARD BALLOON ANGIOPLASTY. THE MID SEGMENT OF THE STENT HAD MILD IN-STENT RESTENOSIS (ISR).THE INTERVENTION WAS REPORTED AS A TARGET LESION/VESSEL REVASCULARISATION (TLR/TVR). THE OUTCOME WAS REPORTED AS RESOLVED/RECOVERED. THE DEVICE REMAINS IMPLANTED. TH

  Patient problems: Impaired Healing; Localized Skin Lesion; Restenosis

  MAUDE report 17256629 ↗
• 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 (B)(6) 2021 THE PATIENT WAS IMPLANTED WITH ONE BIOMIMICS 3D (BM3D) STENT, A 7.0 X 80MM STENT WHICH WAS USED TO TREAT A DENOVO LESION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) MIDDLE THIRD TO DISTAL THIRD IN THE LEFT LEG. A RETROGRADE APPROACH WAS USED AND THE LESION WAS PREPARED USING PRE-DILATION WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON AND ATHERECTOMY. THE TREATED SEGMENT WAS ALSO 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 DEFINITELY RELATED TO THE DEVICE AND NOT RELATED TO THE PROCEDURE. IT WAS REPORTED AS NOT SERIOUS. A DUPLEX ULTRASOUND (DUS) ON (B)(6) 2022 AT THE PATIENT'S 12-MONTH FOLLOW-UP SHOWED ELEVATED VELOCITIES IN THE LEFT SFA. A DIAGNOSTIC ANGIOGRAM PERFORMED ON (B)(6) 2022 SHOWED A 50-60% STENOSIS AT THE PROXIMAL END OF THE TARGET LESION STENT. IT WAS DECIDED TO MANAGE THE EVENT MEDICALLY BY ADDING CILOSTAZOL. NO FURTHER DIAGNOSTICS OR INTERVENTIONS WERE REPORTED. THE PATIENT OUTCOME WAS REPORTED AS CONTINUING AND THE DEVICE REMAINS IMPLANTED. ADDITIONAL INFORMATION

  Patient problems: Restenosis

  MAUDE report 16916659 ↗
• InjurySep 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS RELATES TO MDR NUMBER 3011632150-2022-00085. 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 7.0 X 60MM STENT IN THE SFA PROXIMAL THIRD AND ONE 7.0 X 80MM (THIS REPORT) BM3D STENT IN THE SFA DISTAL THIRD) TO TREAT DENOVO LESIONS IN THE RIGHT LEG. A RETROGRADE APPROACH WAS USED AND THE TARGET LESION WAS PREPARED BY PRE-DILATION OF THE TARGET LESION WITH A STANDARD BALLOON ANGIOPLASTY AND ATHERECTOMY. 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 BARE METAL STENT PLACEMENT, CUTTING BALLOON , LASER ATHERECTOMY AND THROMBECTOMY. THE DEVICES REMAIN IMPLANTED. THE PATIENT OUTCOME IS REPORTED AS "RESOLVED/RECOVERED". THE EVENT WAS REVIEWED ON 22-AUG-22

  Patient problems: Thrombosis/Thrombus

  MAUDE report 15455708 ↗
• InjuryJun 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS MDR IS RELATED TO 3011632150-2022-00031. 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 60MM AND A 7.0 X 80MM) TO TREAT A DENOVO LESION OF THE SFA MIDDLE THIRD TO SFA DISTAL THIRD OF THE LEFT LEG. A CONTRALATERAL 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 AN UNKNOWN DATE IN JUNE 2021, AN EVENT OF THROMBOSIS OF TREATED SEGMENT WAS IDENTIFIED AND REPORTED TO VERYAN ON (B)(6) 2022. IT WAS REPORTED AS "NOT RELATED" TO THE DEVICE OR PROCEDURE BUT TO A WORSENING OF THE PRE-EXISTING CONDITION. THE EVENT REQUIRED A TARGET LESION REVASCULARISATION (TLR) THAT INVOLVED PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY / STANDARD BALLOON ANGIOPLASTY AND THROMBECTOMY. THE EVENT IS REPORTED AS SERIOUS. THE PATIENT OUTCOME IS DESCRIBED AS RESOLVED/RECOVERED. THE DEVICES REMAIN 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: Thrombosis/Thrombus

  MAUDE report 14563033 ↗
• InjuryJun 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS MDR IS RELATED TO 3011632150-2022-00027. 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 60MM AND A 7.0 X 80MM) TO TREAT A DENOVO LESION OF THE SFA MIDDLE THIRD TO 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. ATHERECTOMY WAS ALSO PERFORMED PRE STENT PLACEMENT. ON THE 30-APRIL, AN EVENT OF RESTENOSIS OF TREATED SEGMENT (TARGET LESION) 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." THE DEVICE REMAINS IMPLANTED. ON REVIEW OF THE EVENT AT SAFETY MONITORING REVIEW (SMR) BY VERYAN, IT WAS DETERMINED TO BE POSSIBLY RELATED TO THE DEVICE.

  Patient problems: Restenosis

  MAUDE report 14561798 ↗