BioMimics 3D Vascular Stent System 144700-05Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 05391526850503), received between Jul 16, 2021 and Apr 22, 2026 — classified as 13 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Fracture” (4 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2026Activation Failure

  IT WAS REPORTED THAT A BIOMIMICS STENT WAS PARTIALLY DEPLOYED AND THE HANDLE BROKE. UPON TRYING TO REMOVE THE STENT DELIVERY SYSTEM, THE DISTAL END OF THE STENT DEPLOYED IN THE ARTERY AND FRACTURED INTO PIECES. THE ENTIRE DELIVERY SYSTEM WAS REMOVED AND THE STENT FRAGMENTS WERE EXTRACTED WITH A SNARE. A SECOND STENT WAS DEPLOYED WITHOUT INCIDENT IN THE LEFT ABOVE KNEE POPLITEAL SEGMENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24950812 ↗
• MalfunctionMay 30, 2025Fracture; Deformation Due to Compressive Stress; Fracture; Deformation Due to Compressive Stress

  ON 04-23-25 A VERYAN CLINICAL SALES SPECIALIST RECEIVED INFORMATION THAT A PATIENT PRESENTED TO THE LAB WITH OCCLUSION IN LEFT SFA/POPLITEAL FOLLOWING IMPLANTATION OF 5 X 150 MM BIOMIMICS 3D (BM3D) STENT SYSTEM WHICH WAS IMPLANTED ON THE (B)(6) 2024. AFTER ANGIOGRAM, IT WAS DISCOVERED THAT THERE WERE TWO FRACTURES IN THE 5X150 BIOMIMICS STENT AND THE PHYSICIAN COULD NOT CROSS FRACTURED STENT AND WILL BRING BACK PATIENT TO TREAT FROM A RETROGRADE APPROACH. IT WAS REPORTED THAT THE PATIENT REQUIRED A PROLONGED EPISODE OF CARE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions; Obstruction/Occlusion

  MAUDE report 22112630 ↗
• MalfunctionApr 24, 2025Fracture; Fracture

  ON 25-MAR-25 A VERYAN SALES SPECIALIST RECEIVED INFORMATION THAT REPORTED THAT A PATIENT PRESENTED WITH A COLD LEG AFTER 5 X 150MM BIOMIMICS 3D (BM3D) STENT WAS IMPLANTED ON (B)(6) 24. AN ANGIO WAS TAKEN TO VERIFY THAT THE STENT HAD FRACTURED IN THE RIGHT FEMOPOPLITEAL SEGMENT AND WAS THE CAUSE OF THE OCCLUSION THAT BLOCKED FLOW TO THE LOWER EXTREMITY. THE PATIENT WAS ADMINISTERED TPA FOR 24 HOURS AND FURTHER INTERVENTION WAS REQUIRED TO OPEN UP OCCLUDED STENT AND REPAIR FRACTURED STENT.

  Patient problems: Limb Pain; Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 21899466 ↗
• MalfunctionFeb 20, 2025Activation Failure; Activation Failure

  THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) RECEIVED A MEDICAL DEVICE REPORT (B)(4) VIA THE MEDSUN PROGRAM CONCERNING A BIOMIMICS 3D VASCULAR STENT SYSTEM, IT WAS REPORTED AS ATTEMPTED TO DELIVER STENT BUT UNSUCCESSFUL. BROKE OFF ON RETRIEVAL". THE EXACT DATE WAS NOT REPORTED IT WAS DOCUMENTED AS ON (B)(6) 2025. THE PATIENT IMPACT WAS NOT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 21419033 ↗
• InjuryJan 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS RELATED TO MDR REPORT 3011632150-2023-00152. 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 (THE SUBJECT OF THIS REPORT) 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 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 18533038 ↗
• InjurySep 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS RELATED TO MDR REPORT 3011632150-2023-00114. 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 IN THE RIGHT LEG, A 5.0 X 150 MM STENT (THE SUBJECT OF THIS REPORT) 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 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) BALLOON. 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 A

  Patient problems: Pain; Restenosis; Skin Discoloration

  MAUDE report 17688745 ↗
• InjuryAug 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS RELATED TO MDR NUMBER 3011632150-2023-00095. 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 (THE SUBJECT OF THIS REPORT) AND A 6.0 X 80 MM STENT WHICH WERE USED TO TREAT A RESTENOTIC LESION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) OSTIAL TO DISTAL 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 SUFFERED FROM CLAUDICATION DUE TO PROGRESSIVE ATHEROSCLEROTIC ARTERIAL OCCLUSIVE DISEASE CONFIRMED BY ULTRASOUND. ON (B)(6) 2023, THE SFA PROXIMAL THIRD WAS TREATED WITH DRUG COATED BALLOON / DRUG ELUTING BALLOON (DCB/DEB), PTA / STANDARD BALLOON ANGIOPLASTY, AND LASER/ATHERECTOMY. IT WAS REPORTED AS A TARGE

  Patient problems: Pain; Restenosis

  MAUDE report 17446578 ↗
• InjuryJul 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS RELATED TO MDR NUMBER 3011632150-2023-00081. 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, A 5.0 X 150 MM STENT (THE SUBJECT OF THIS REPORT) AND A 6.0 X 150 MM STENT WHICH WERE USED TO TREAT A RESTENOTIC LESION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) MIDDLE THIRD TO PROXIMAL POPLITEAL ARTERY IN THE LEFT LEG. AN ANTEGRADE 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 AND A DRUG COATED/ DRUG ELUTING BALLOON (DCB/DEB). 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. THE PATIENT HAD THEIR LEFT POPLITEAL, LEFT SFA AND LEFT POSTERIOR TIBIAL (PT) ARTERY REVASCULARISED USING PTA / STANDARD BALLOON ANGIOPLASTY, DCB/DEB AND SHOCKWAVE TREATMENT ON THE SFA PROXIMAL THIRD TO PT DISTAL THIRD ON (B)(6) 2022. THE INTERVENTION WAS REPORTED AS A T

  Patient problems: Restenosis

  MAUDE report 17255666 ↗
• InjuryJul 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS RELATED TO MDR NUMBER 3011632150-2023-00083. 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 150 MM (THE SUBJECT OF THIS REPORT) STENT AND A 6.0 X 150 MM STENT WHICH WERE USED TO TREAT A RESTENOTIC LESION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) MIDDLE THIRD TO PROXIMAL POPLITEAL ARTERY IN THE LEFT LEG. AN ANTEGRADE 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 AND A DRUG COATED/ DRUG ELUTING BALLOON (DCB/DEB). 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 HAD THEIR LEFT POPLITEAL AND LEFT SFA REVASCULARISED USING PTA / STANDARD BALLOON ANGIOPLASTY, DCB/DEB, LASER ATHERECTOMY AND NON BM3D BARE METAL COVERED STENT PLACEMENT ON THE SFA OSTIAL TO POSTERIOR TIBIAL (PT) DISTAL THIRD ON (B)(6) 2023. THE INTERVENT

  Patient problems: Restenosis

  MAUDE report 17255453 ↗
• InjuryJun 29, 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 150 MM STENT WHICH WAS USED TO TREAT A DENOVO LESION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) MIDDLE THIRD 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. A COMPETITOR STENT WAS ALSO PLACED AFTER THE BM3D WAS IMPLANTED. THE SITE IDENTIFIED A RESTENOSIS OF TREATED SEGMENT (TARGET LESION) ON (B)(6) 2022. IT WAS REPORTED AS POSSIBLY RELATED TO THE DEVICE AND PROCEDURE. IT WAS ALSO REPORTED AS TARGET LESION RELATED. AN INTERVENTION ON (B)(6) 2022 CONDUCTED ON THE SFA PROXIMAL THIRD TO 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: Restenosis

  MAUDE report 17233232 ↗
• InjuryMar 27, 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 150MM STENT WHICH WAS USED TO TREAT A DENOVO LESION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) MIDDLE THIRD TO DISTAL THIRD SEGMENT IN THE RIGHT LEG. AN ANTEGRADE 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) 2023, 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. THE PATIENT EXPERIENCED RIGHT LEG EXTREMITY (RLE) CLAUDICATION. AN INTERVENTION ON (B)(6) 2023 INVOLVED PTA/STANDARD BALLOON ANGIOPLASTY AND LASER ATHERECTOMY OF THE SFA MIDDLE THIRD TO PROXIMAL POPLITEAL ARTERY. IT WAS REPORTED AS A TARGET LESION REVASCULARISATION (TLR) AND TARGET VESSEL REVASCULARISATION (TVR). THE PATIENT OUTCOME WAS REPORTED AS RESOLVED/RECOVERED AND THE DEVICE REMAINS IMPLANTED.

  Patient problems: Pain; Restenosis

  MAUDE report 16622845 ↗
• InjuryFeb 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS RELATED TO MDR NUMBER 3011632150-2023-00025. 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 (BM3D), A 5.0 X 150MM STENT (THE SUBJECT OF THIS REPORT) AND A 6.0 X 80MM STENT TO TREAT A RESTENOTIC LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) OSTIAL TO DISTAL THIRD 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, AN OCCLUSION 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. THE PATIENT PRESENTED FOR AN ULTRASOUND ON (B)(6) 2022, WHICH REVEALED AN OCCLUDED SFA BUT THE PATIENT STATED THAT SHE WAS RELATIVELY ASYMPTOMATIC. THE PHYSICIAN DECIDED AT THE TIME TO REPEAT THE EXAMINATION IN 6 MONTHS AND NO INTERVENTION WAS PLANNED. ON (B)(6) 2022 AN INTERVENTION WAS CONDUCTED WHICH INVOLVED PTA / STANDARD BALLOON ANGIOPLASTY AND LASER ATHEREC

  Patient problems: Obstruction/Occlusion

  MAUDE report 16426164 ↗
• MalfunctionFeb 15, 2023Fracture; Stretched; Activation Failure; Fracture; Stretched; Activation Failure

  THIS IS RELATED TO MDR NUMBER 3011632150-2023-00027. ON THE (B)(6) 2023, A VERYAN REPRESENTATIVE WAS MADE AWARE OF DETAILS OF A PROCEDURE THAT INVOLVED FOUR BIOMIMICS 3D (BM3D) DEVICES. THE VESSEL ANATOMY WAS REPORTED AS TORTUOUS WITH A TIGHT AORTIC BIFURCATION. THE VESSEL WAS HEAVILY CALCIFIED. THE FIRST DEVICE A BM3D 5.0 X 150MM STENT (THE SUBJECT OF THIS REPORT) WAS IMPLANTED USING A CONTRALATERAL APPROACH. FOLLOWING PARTIAL DEPLOYMENT OF THE STENT, 1CM BROKE OFF DURING THE ATTEMPTED REMOVAL OF THE DEVICE. THE 1CM PORTION WHICH HAD DEPLOYED WAS FULLY EXPANDED. THE SECOND STENT DEPLOYED WAS A BM3D 5.0 X 150MM STENT AND WAS IMPLANTED IN THE SAME ANATOMICAL LOCATION WHERE THE FIRST STENT IMPLANTATION WAS ATTEMPTED BUT A TIBIAL/PEDAL APPROACH WAS USED AND THIS STENT WAS DEPLOYED SUCCESSFULLY. THE THIRD STENT A BM3D 6.0 X 150MM STENT WAS IMPLANTED USING A CONTRALATERAL APPROACH AND WAS REPORTED AS DIFFICULT TO DEPLOY. THE FOURTH AND LAST STENT, A BM3D 6.0 X 125MM STENT WAS SUCCESSFULLY DEPLOYED USING A CONTRALATERAL APPROACH. THERE WERE WAS NO REPORTED IMPACT TO THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16377572 ↗
• InjuryFeb 15, 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) 2022, THE PATIENT WAS IMPLANTED WITH ONE 5.0 X 150MM BIOMIMICS 3D (BM3D) STENT TO TREAT A DENOVO LESION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) MIDDLE THIRD TO SFA DISTAL THIRD SEGMENT IN THE RIGHT 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 REPORTED THAT ON (B)(6) 2023, A RESTENOSIS OF TREATED SEGMENT (TARGET LESION) WAS IDENTIFIED. IT WAS REPORTED AS POSSIBLY RELATED TO THE DEVICE AND NOT RELATED TO THE PROCEDURE. IT WAS REPORTED AS TARGET LESION RELATED. THE PATIENT ATTENDED CLINIC ON THE (B)(6) 2023 COMPLAINING OF RECURRENT RIGHT LEG PAIN. AN ULTRASOUND REVEALED A GREATER THAN 50 PERCENT STENOSIS IN THE PROXIMAL SFA BEFORE THE STENTED SEGMENT, AND A GREATER THAN 50 PERCENT STENOSIS WITHIN THE STENT IN THE SFA. AN ANGIOGRAM CONDUCTED ON THE (B)(6) 2023 SHOWED A 90 PERCENT STENOSIS OF THE RIGHT COMMON FEMORAL ARTERY (CFA), 95 PERCENT STENOSIS OF THE PROFUNDA, 80 PERCENT STENOSIS OF THE ORIGIN OF THE SFA, AND DIFFUSE 80 PERCENT I

  Patient problems: Pain; Restenosis

  MAUDE report 16377566 ↗
• 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 3011632150-2023-00014. 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 150MM STENT - THE SUBJECT OF THIS REPORT AND A 5.0 X 60MM STENT) 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 (B)(6) 2022 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 ((B)(6) 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 M

  Patient problems: Ischemia; Pain; Restenosis

  MAUDE report 16264105 ↗
• MalfunctionOct 10, 2022Fracture; Fracture

  THIS IS RELATED TO MDR NUMBER 3011632150-2022-00095. THE PATIENT WAS ENROLLED IN THE MIMICS 3D POST MARKET OBSERVATIONAL US REGISTRY STUDY ON THE (B)(6) 2021. THE PATIENT WAS TREATED WITH TWO BIOMIMICS 3D (BM3D) STENTS ( ONE STENT (THE SUBJECT OF THIS REPORT) WAS A 5.0 X 150MM STENT AND THE OTHER WAS A 6.0 X 150MM STENT ) TO TREAT A RESTENOTIC LESION OF THE SFA MIDDLE THIRD TO PROXIMAL POPLITEAL ARTERY IN THE LEFT LEG. AN ANTEGRADE APPROACH WAS USED AND THE TARGET LESION WAS PREPARED USING PRE-DILATION WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON AND ATHERECTOMY. THE STENT WAS POST-DILATED WITH PTA AND ALSO WITH A DRUG COATED/DRUG ELUTING BALLOON. ON THE 12-SEPT-22 A RESTENOSIS OF THE TREATED VESSEL OCCURRED WHICH WAS REPORTED AS POSSIBLY RELATED TO THE DEVICE AND TARGET LESION RELATED. IT LED TO INTERVENTION ON THE TARGET LESION WHICH INCLUDED DRUG COATED BALLOON/DRUG ELUTING BALLOON AND PTA AS WELL AS ATHERECTOMY AND SHOCKWAVE THERAPY. ON THE SAME DAY A TYPE I SINGLE STRUT STENT FRACTURE OF THE IMPLANTED 5.0 X 150MM BM3D STENT WAS IDENTIFIED. THE REPORTED REGION OF STENT FRACTURE WAS POINT OF STENT OVERLAP WITH THE SECOND 6.0 X 150MM BM3D STENT IN THE DISTAL SFA TO PR

  Patient problems: Restenosis

  MAUDE report 15572934 ↗
• InjuryOct 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS RELATED TO MDR NUMBER 3011632150-2022-00091. 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 (THE SUBJECT OF THIS REPORT) TO TREAT A DENOVO LESION OF THE SFA PROXIMAL THIRD TO MIDDLE THIRD AND A 5.0 X 60MM STENT 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 15556117 ↗
• InjuryJun 1, 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 STENT (A 5.0 X 150MM) TO TREAT A DENOVO LESION OF THE SFA MIDDLE THIRD TO DISTAL THIRD OF THE LEFT LEG. A RETROGRADE APPROACH WAS USED AND PRE-DILATATION OF THE TARGET LESION WAS CONDUCTED WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. ATHERECTOMY WAS ALSO PERFORMED PRE-STENT PLACEMENT. ON (B)(6) 2021, A RESTENOSIS OF TREATED SEGMENT WAS IDENTIFIED. IT WAS REPORTED AS "NOT RELATED" TO THE DEVICE OR PROCEDURE BUT TO A WORSENING OF THE PRE-EXISTING CONDITION. THE INTERVENTION REQUIRED A TARGET LESION REVASCULARISATION (TLR) ON (B)(6) 2022 THAT INVOLVED BARE METAL STENT PLACEMENT, PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY / STANDARD BALLOON ANGIOPLASTY, LASER ATHERECTOMY. THE PATIENT OUTCOME IS REPORTED AS RESOLVED/RECOVERED. THE DEVICE REMAINS 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: Restenosis

  MAUDE report 14564700 ↗
• InjuryApr 25, 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 MIMICS 3D USA POST-MARKET OBSERVATIONAL STUDY ON (B)(6) 2021 TO TREAT A DENOVO OCCLUSION IN THE SFA MIDDLE THIRD TO DISTAL THIRD OF THE LEFT LEG. AN EVENT OF RESTENOSIS OF TREATED SEGMENT (TARGET LESION) WAS ORIGINALLY REPORTED TO VERYAN AS NOT RELATED TO THE DEVICE BUT ON REVIEW OF THE EVENT AS THIS LED TO A REVASCULARISATION ON THE TARGET LESION IT WAS CONSIDERED POSSIBLY RELATED TO THE DEVICE. THE INTERVENTION INCLUDED NON BIOMIMICS 3D STENT PLACEMENT, PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY / STANDARD BALLOON ANGIOPLASTY, LASER/ATHERECTOMY. THE OUTCOME OF THE EVENT IS REPORTED AS RESOLVED/RECOVERED. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Pain; Restenosis

  MAUDE report 14192769 ↗
• MalfunctionJul 16, 2021Difficult or Delayed Positioning; Difficult or Delayed Activation; Malposition of Device; Positioning Problem; Physical Resistance/Sticking; Difficult or Delayed Positioning; Difficult or Delayed Activation; Malposition of Device; Positioning Problem; Physical Resistance/Sticking

  THIS MDR REPORT IS RELATED TO MDR NUMBER 3011632150-2021-00031. THE PROCEDURE IN QUESTION INVOLVED THE IMPLANTATION OF TWO 150MM BIOMIMICS 3D STENTS TO TREAT A LONG TARGET LESION FROM THE DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) TO POPLITEAL ARTERY. FOLLOWING STENT DELIVERY SYSTEM (SDS) PREPARATION, THE SDS WAS TRACKED OVER THE ILIAC BIFURCATION TO THE PROXIMAL POPLITEAL ARTERY USING A 6FR X 45CM FLEXOR ANSEL 1 CURVE ANCILLARY SHEATH OVER A 0.014" GUIDEWIRE. THERE WAS SEVERE VESSEL TORTUOSITY AND A TIGHT BIFURCATION ANGLE. A CROSS-OVER APPROACH WAS USED, AND IT WAS REPORTED THAT NO RESISTANCE WAS FELT DURING THE APPROACH OF THE DEVICE TO THE TARGET SITE. UPON INITIATION OF DEPLOYMENT, THE PHYSICIAN EXPERIENCED RESISTANCE AND AT FIRST WAS UNABLE TO RETRACT THE OUTER BRAID. THE SDS WAS SLIGHTLY RETRACTED TO REMOVE SLACK AND THE TUOHY BORST WAS UNLOCKED. THE PHYSICIAN MADE SEVERAL ATTEMPTS TO CONTINUE THE DEPLOYMENT, AND USED SIGNIFICANT FORCE THROUGHOUT THE DEPLOYMENT PROCEDURE TO GET THE STENT TO RELEASE. THE PHYSICIAN ALSO NEEDED TO PAUSE AND REPOSITION THE DEVICE AT THE TARGET SITE BETWEEN DEPLOYMENT ATTEMPTS. THE FIRST STENT IMPLANTED (A 5 X 150MM STENT) WAS POSITIONED SLIGHTLY MO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12180823 ↗