BioMimics 3D Vascular Stent System 142122-06Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 05391526850428), received between May 23, 2022 and Feb 4, 2025 — classified as 15 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PATIENT WAS ENROLLED IN THE MIMICS 3D USA POST-MARKET OBSERVATIONAL REGISTRY STUDY. ON (B)(6) 2021, THE PATIENT WAS IMPLANTED WITH ONE BIOMIMICS 3D (BM3D) STENT. A 6.0 X 80 MM STENT WAS USED TO TREAT A DENOVO LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) MIDDLE THIRD IN THE LEFT LEG. A CONTRALATERAL APPROACH WAS USED AND THE LESION WAS PREPARED WITH PRE-DILATION USING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON AND ATHERECTOMY. THE TREATED SEGMENT WAS POST-DILATED WITH A PTA BALLOON. ON (B)(6) 2024, THE SITE IDENTIFIED A RESTENOSIS OF TREATED SEGMENT (TARGET LESION). THE RELATIONSHIP TO THE DEVICE WAS NOT REPORTED BUT IT WAS NOT RELATED TO THE PROCEDURE. IT WAS TARGET LESION-RELATED. THE EVENT REQUIRED SURGERY. THIS INVOLVED PTA/STANDARD BALLOON ANGIOPLASTY OF THE SFA MIDDLE THIRD TO SFA DISTAL THIRD SEGMENT ON (B)(6) 2024. THE SITE REPORTED THAT COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) SHOWED NEAR COMPLETE IN-STENT RESTENOSIS OF THE DISTAL SFA. THE REMAINDER OF THE UNSTENTED SFA DEMONSTRATES MILD DISEASE WITHOUT SIGNIFICANT STENOSIS. IT WAS A TARGET LESION/VESSEL REVASCULARISATION (TLR/TVR). THE OUTCOME WAS REPORTED AS RESOLVED/RECOVERED. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Restenosis

  MAUDE report 21305365 ↗
• InjuryJan 11, 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 IN THE LEFT LEG, A 6.0 X 80 MM STENT WHICH WAS USED TO TREAT A RESTENOTIC LESION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) DISTAL THIRD TO PROXIMAL POPLITEAL ARTERY. A CONTRALATERAL APPROACH WAS USED AND THE LESION WAS PREPARED USING PRE-DILATION WITH A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON, ATHERECTOMY AND CUTTING BALLOON. THE TREATED SEGMENT WAS POST-DILATED WITH PTA. THE SITE IDENTIFIED AN ARTERIAL STENOSIS (NON-TARGET, DE-NOVO) EVENT ON 11-JUL-23. IT WAS REPORTED AS NOT RELATED TO THE DEVICE AND NOT RELATED TO THE PROCEDURE BUT WAS DUE TO A WORSENING PRE-EXISTING CONDITION. IT WAS NOT TARGET LESION RELATED. THE LEFT TIBIOPERONEAL TRUNK (TPT) AND POSTERIOR TIBIAL (PT) ARTERY WERE TREATED WITH PTA/STANDARD BALLOON ANGIOPLASTY ON (B)(6) 2023. THE EVENT WAS TREATED AS PART OF AN INTERVENTION ON THE SFA DISTAL THIRD TO POSTERIOR TIBIAL PROXIMAL THIRD. THIS INTERVENTION ALSO TREATED AN OCCLUSION OF THE BM3D STENT IDENTIFIED ON (B)(6) 2023 AND A SUSPECTED STENT FRACTURE (MDR 3011632150-2023-00085) WHERE A NON-BM3

  Patient problems: Stenosis

  MAUDE report 18495416 ↗
• InjuryNov 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) 2021, THE PATIENT WAS IMPLANTED WITH ONE 6.0 X 80MM BIOMIMICS 3D (BM3D) STENT. IT WAS USED TO TREAT A DENOVO LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) DISTAL THIRD IN THE RIGHT LEG. AN ANTEGRADE APPROACH WAS USED AND THE LESION WAS PREPARED USING PREDILATION WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON AND ATHERECTOMY. ON (B)(6) 2022, AN EVENT OF RESTENOSIS OF TREATED SEGMENT (TARGET LESION) WAS IDENTIFIED. IT WAS SITE REPORTED AS DEFINITELY RELATED TO THE DEVICE AND NOT RELATED TO THE PROCEDURE AND IT WAS TARGET LESION RELATED. IT REQUIRED PERCUTANEOUS INTERVENTION ON (B)(6) 2022, THAT INVOLVED PTA/STANDARD BALLOON ANGIOPLASTY AND LASER ATHERECTOMY ON THE SFA DISTAL THIRD. IT WAS REPORTED AS A TARGET LESION/VESSEL REVASCULARISATION (TLR/TVR). THE PATIENT OUTCOME WAS REPORTED AS RESOLVED/RECOVERED AND THE DEVICE REMAINS IMPLANTED. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2024 BY THE SITE UPDATED THE PROCEDURE RELATIONSHIP FROM POSSIBLY RELATED TO NOT RELATED.

  Patient problems: Restenosis

  MAUDE report 18145389 ↗
• InjuryOct 25, 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 6.0 X 150 MM BIOMIMICS 3D (BM3D) STENT (THE STUDY STENT) IN THE SFA MIDDLE THIRD TO PROXIMAL POPLITEAL SEGMENT IN THE LEFT LEG. ON (B)(6) 2021, THE SITE IDENTIFIED A RESTENOSIS OF TREATED SEGMENT (TARGET LESION) (MDR NUMBER 3011632150-2022-00056) AND AN ADDITIONAL NON-STUDY 6.0 X 80 MM BM3D STENT (THE SUBJECT OF THIS REPORT) WAS PLACED IN THE SFA OSTIAL TO SFA PROXIMAL THIRD TO TREAT A DENOVO LESION IN THE LEFT LEG. A CONTRALATERAL APPROACH WAS USED, AND THE LESION WAS PREPARED USING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON AND ATHERECTOMY. THE TREATED SEGMENT WAS ALSO POST-DILATED WITH PTA. THE SITE IDENTIFIED A RESTENOSIS OF TREATED VESSEL (TARGET VESSEL) ON (B)(6) 2023. IT WAS NOT RELATED TO THE STUDY DEVICE OR STUDY PROCEDURE BUT WAS DUE TO A WORSENING PRE-EXISTING CONDITION. THE PATIENT HAD LEFT LOWER EXTREMITY (LLE) PAIN AND A SLOWLY HEALING WOUND TO THE LLE. DUPLEX ULTRASOUND (DUS) ON (B)(6) 2023 SHOWED SEVERE STENOSIS OF THE PROFUNDA FEMORIS ARTERY (PFA), COMMON FEMORAL ARTERY (CFA) AND SFA. THE LEFT OSTIAL SFA AND PFA WERE SUCC

  Patient problems: Impaired Healing; Pain; Restenosis

  MAUDE report 18002443 ↗
• 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 3011632150-2023-00094. 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 AND A 6.0 X 80 MM STENT (THE SUBJECT OF THIS REPORT) 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 17443386 ↗
• MalfunctionJul 7, 2023Fracture; Insufficient Device Problem Information; Fracture; Insufficient Device Problem Information

  THE PATIENT WAS TREATED AS PART OF THE MIMICS 3D USA POST-MARKET OBSERVATIONAL STUDY. ON THE 05-JUL-22, THE PATIENT WAS IMPLANTED WITH ONE BIOMIMICS 3D (BM3D) STENT IN THE LEFT LEG, A 6.0 X 80MM STENT WHICH WAS USED TO TREAT A DENOVO LESION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) DISTAL THIRD TO PROXIMAL POPLITEAL ARTERY. A CONTRALATERAL APPROACH WAS USED AND THE LESION WAS PREPARED USING PRE-DILATION WITH A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON, CUTTING BALLOON AND ATHERECTOMY. THE TREATED SEGMENT WAS POST-DILATED WITH PTA. A STENT FRACTURE WAS IDENTIFIED ON 16-MAY-23, IT WAS REPORTED AS DEFINITELY RELATED TO THE DEVICE AND NOT RELATED TO THE PROCEDURE. IT WAS TARGET LESION RELATED. THE PATIENT PRESENTED WITH PAIN OF THE LEFT LEG. DUPLEX ULTRASOUND (DUS) DISPLAYED OCCLUSION OF THE STENT (MDR REPORT REFERENCE: 3011632150-2023-00109). A PERCUTANEOUS INTERVENTION WAS ATTEMPTED INITIALLY BUT THE STENTED SEGMENT COULD NOT BE CROSSED. ON 11-JUL-23, PERCUTANEOUS INTERVENTION WAS ATTEMPTED AGAIN AND A NON BM3D BARE METAL STENT WAS DEPLOYED TO MAINTAIN PATENCY OF THE EXISTING BM3D STENT. PTA/STANDARD BALLOON ANGIOPLASTY WAS ALSO PERFORMED. THE INTERVENTION WAS REPORTED AS A T

  Patient problems: Insufficient Information; Pain

  MAUDE report 17276861 ↗
• InjuryFeb 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS RELATED TO MDR NUMBER 3011632150-2023-00024. 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 STENTS (BM3D), A 5.0 X 150MM STENT AND A 6.0 X 80MM (THE SUBJECT OF THIS REPORT) 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 THE (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

  Patient problems: Obstruction/Occlusion

  MAUDE report 16426166 ↗
• InjuryJan 30, 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) 2022, THE PATIENT WAS IMPLANTED WITH ONE BIOMIMICS 3D (BM3D) STENT (A 6.0 X 80MM STENT) TO TREAT A DENOVO LESION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) DISTAL THIRD TO PROXIMAL POPLITEAL SEGMENT 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 SITE REPORTED THAT ON (B)(6) 2022, A RESTENOSIS OF TREATED SEGMENT (TARGET LESION) WAS IDENTIFIED. THE PATIENT WAS SEEN IN THE CLINIC ON 27-DEC-22 FOR FOLLOW-UP REVIEW. THE PATIENT REPORTED THAT SHE HAD DEVELOPED PAIN IN HER FEET WITH VERY SHORT DISTANCE CLAUDICATION. IT STARTED FIRST ON THE LEFT LEG AND THEN SHORTLY AFTER SIMILAR SYMPTOMS FOLLOWED IN THE RIGHT LEG. DUPLEX ULTRASOUND (DUS) ON THE 27-DEC-22 SHOWED A 50-75% STENOSIS IN INFLOW TO THE BM3D STENT AND >50% STENOSIS IN THE MED SEGMENT OF THE BM3D STENT. THERE WAS ALSO 50-75% STENOSIS OF THE LEFT MIDDLE POPLITEAL SEGMENT. THE LEFT COMMON FEMORORAL ARTERY (CFA), PROXIMAL SFA AND MIDDLE SFA SHOWED <50% STENOSIS. THE ANKLE BRACHIAL INDEX (ABI) ON THE LEFT WAS MEASURED AT 0.3

  Patient problems: Pain; Restenosis

  MAUDE report 16264066 ↗
• InjuryJan 16, 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 STENT (A 6 X 80MM STENT) TO TREAT A DENOVO LESION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) MIDDLE THIRD TO SFA DISTAL THIRD SEGMENT 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 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 INTERVENTION TOOK PLACE ON (B)(6) 2022 AND CONSISTED OF PTA/STANDARD BALLOON ANGIOPLASTY AND LASER ATHERECTOMY OF THE SFA DISTAL THIRD TO PROXIMAL POPLITEAL SEGMENT. THIS WAS REPORTED AS A TARGET LESION REVASCULARISATION (TLR)/TARGET VESSEL REVASCULARISATION (TVR). THIS EVENT WAS REVIEWED BY VERYAN ON 19-DEC-22 AND CONSIDERED POSSIBLY RELATED TO THE DEVICE. THE PATIENT OUTCOME WAS REPORTED AS RESOLVED/RECOVERED AND THE DEVICE REMAINS IMPLANTED.

  Patient problems: Pain; Restenosis

  MAUDE report 16172805 ↗
• InjuryDec 14, 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 TREATED WITH ONE 6.0 X 80MM BIOMIMICS 3D (BM3D) STENT TO TREAT A DENOVO LESION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) MIDDLE THIRD TO DISTAL THIRD IN THE RIGHT LEG. AN ANTEGRADE APPROACH WAS USED AND THE LESION WAS PREPARED USING ATHERECTOMY AND PRE-DILATED WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). THE LESION WAS ALSO POST-DILATED WITH PTA. THE SITE REPORTED THAT ON (B)(6) 2022, A RESTENOSIS OF THE TREATED SEGMENT (TARGET LESION) WAS IDENTIFIED. A SEVERE RIGHT SFA IN-STENT RESTENOSIS (ISR) WAS TREATED WITH LASER ATHERECTOMY AND DRUG COATED BALLOON (DCB) ANGIOPLASTY. A RIGHT POPLITEAL ISR WAS TREATED WITH LASER ATHERECTOMY AND DCB AND THE RIGHT TIBIOPERONEAL TRUNK (TPT) WAS ALSO TREATED WITH LASER ATHERECTOMY AND PLAIN OLD BALLOON ANGIOPLASTY (POBA). THE RESTENOSIS EVENT WAS REPORTED AS NOT RELATED TO THE DEVICE OR PROCEDURE BUT DUE TO A WORSENING OF THE PATIENT'S PRE-EXISTING CONDITION. IT WAS REPORTED AS TARGET LESION RELATED. IT WAS REVIEWED BY VERYAN ON 28-NOV-22 AND CONSIDERED POSSIBLY RELATED TO THE DEVICE. THE DEVICE REMAINS IMPLANTED AND THE EVENT IS

  Patient problems: Impaired Healing; Restenosis

  MAUDE report 15979026 ↗
• InjuryDec 14, 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) 2022, THE PATIENT WAS TREATED WITH ONE 6.0 X 80MM BIOMIMICS 3D (BM3D) STENT 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 ATHERECTOMY AND PRE-DILATED WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). THE LESION WAS ALSO POST-DILATED WITH PTA. THE SITE REPORTED THAT ON (B)(6) 2022, A RESTENOSIS OF THE TREATED SEGMENT (TARGET LESION) WAS IDENTIFIED. A RIGHT DISTAL SFA IN-STENT RESTENOSIS (80-90%) WAS TREATED WITH LASER ATHERECTOMY AND PTA/STANDARD BALLOON ANGIOPLASTY ON 08-NOV-22. IT WAS REPORTED AS A TARGET LESION REVASCULARISATION/TARGET VESSEL REVASCULARISATION (TLR/TVR). THERE WAS STENOSIS OF THE MIDDLE SFA TREATED WITH ANGIOPLASTY, LASER ATHERECTOMY AND STENTING. THERE WAS ALSO STENOSIS OF THE POPLITEAL AND TIBIOPERONEAL TRUNK (TPT) TREATED WITH ANGIOPLASTY AND LASER ATHERECTOMY. THE RESTENOSIS EVENT WAS REPORTED AS NOT RELATED TO THE DEVICE OR PROCEDURE BUT DUE TO A WORSENING OF THE PATIENT'S PRE-EXISTING CONDITION. IT WAS REPORTED AS TARGET LESION

  Patient problems: Restenosis

  MAUDE report 15978964 ↗
• InjuryDec 14, 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 TREATED WITH ONE 6.0 X 80MM BIOMIMICS 3D (BM3D) STENT TO TREAT A DENOVO LESION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) MIDDLE THIRD TO DISTAL THIRD IN THE RIGHT LEG. AN ANTEGRADE APPROACH WAS USED AND THE LESION WAS PREPARED USING ATHERECTOMY AND PRE-DILATED WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). THE LESION WAS ALSO POST-DILATED WITH PTA. THE SITE REPORTED THAT ON (B)(6) 2021, A RESTENOSIS OF THE TREATED SEGMENT (TARGET LESION) WAS IDENTIFIED. A SEVERE RIGHT MIDDLE SFA IN-STENT RESTENOSIS WAS TREATED WITH LASER ATHERECTOMY AND ANGIOPLASTY. AN OCCLUDED RIGHT POPLITEAL AND TIBIOPERONEAL TRUNK (TPT)/PERONEAL WAS ALSO TREATED WITH LASER ATHERECTOMY AND ANGIOPLASTY. THE RESTENOSIS EVENT WAS REPORTED AS NOT RELATED TO THE DEVICE OR PROCEDURE BUT DUE TO A WORSENING OF THE PATIENT'S PRE-EXISTING CONDITION. IT WAS REPORTED AS TARGET LESION RELATED. IT WAS REVIEWED BY VERYAN ON 28-NOV-22 AND CONSIDERED POSSIBLY RELATED TO THE DEVICE. THE DEVICE REMAINS IMPLANTED AND THE EVENT IS REPORTED AS RESOLVED/RECOVERED.

  Patient problems: Localized Skin Lesion; Restenosis

  MAUDE report 15978862 ↗
• InjuryDec 7, 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 6.0 X 80MM BIOMIMICS 3D (BM3D) STENT. THIS WAS USED TO TREAT A DE NOVO LESION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) MIDDLE THIRD IN THE LEFT LEG. A CONTRALATERAL APPROACH WAS USED AND THE LESION WAS PREPARED USING STANDARD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) AND ATHERECTOMY. THE TREATED SEGMENT WAS ALSO POST-DILATED WITH PTA. IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT HAD A DUPLEX ULTRASOUND (DUS) WHICH SHOWED A LEFT SFA STENT OCCLUSION. A LEFT LEG LOWER EXTREMITY (LLE) ANGIOGRAM WAS PERFORMED AND LASER ATHERECTOMY AND PTA WAS CONDUCTED ON (B)(6) 2022 ON SFA OSTIAL AND SFA DISTAL THIRD IN THE LEFT LEG. IT IS REPORTED AS A TARGET LESION REVASCULARISATION (TLR) AND TARGET VESSEL REVASCULARISATION (TVR). THE EVENT OUTCOME WAS REPORTED AS RESOLVED/RECOVERED. THE EVENT WAS REPORTED AS "NOT RELATED" TO THE BM3D DEVICE AND "NOT RELATED" TO THE STUDY PROCEDURE DUE TO A WORSENING OF THE PATIENT'S PRE-EXISTING CONDITION AND TARGET LESION RELATED. THE EVENT WAS REVIEWED BY VERYAN AND CONSIDERED POSSIBLY RELATED TO THE DEVICE ON (B)(6) 2022. T

  Patient problems: Restenosis

  MAUDE report 15932837 ↗
• InjuryDec 7, 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 6.0 X 80MM BIOMIMICS 3D (BM3D) STENT. THIS WAS USED TO TREAT A DE NOVO LESION OF THE SFA MIDDLE THIRD IN THE LEFT LEG. A CONTRALATERAL APPROACH WAS USED AND THE LESION WAS PREPARED USING STANDARD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) AND ATHERECTOMY. THE TREATED SEGMENT WAS ALSO POST-DILATED WITH PTA. IT WAS REPORTED THAT ON (B)(6) 2022 , THE PATIENT HAD A DUPLEX ULTRASOUND (DUS) WHICH SHOWED A LEFT SFA IN-STENT RESTENOSIS. A LASER ATHERECTOMY AND DRUG COATED BALLOON / DRUG ELUTING BALLOON WAS CONDUCTED ON (B)(6) 2021 ON SFA PROXIMAL THIRD TO SFA MIDDLE THIRD IN THE LEFT LEG. IT IS REPORTED AS A TARGET LESION REVASCULARISATION (TLR) AND TARGET VESSEL REVASCULARISATION (TVR). THE EVENT OUTCOME WAS REPORTED AS RESOLVED/RECOVERED. THE EVENT WAS REPORTED AS "NOT RELATED" TO THE BM3D DEVICE AND "NOT RELATED" TO THE STUDY PROCEDURE BUT DUE TO A WORSENING OF THE PATIENT'S PRE-EXISTING CONDITION AND TARGET LESION RELATED. THE EVENT WAS REVIEWED BY VERYAN AND CONSIDERED POSSIBLY RELATED TO THE DEVICE ON (B)(6) 2022 .THE DEVICE REMAINS IMPLANTED.

  Patient problems: Restenosis

  MAUDE report 15932829 ↗
• InjuryOct 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) 2022. THE SUBJECT WAS IMPLANTED WITH ONE BIOMIMICS 3D (BM3D) STENT ( 6.0 X 80MM STENT) TO TREAT A DENOVO LESION OF THE SFA PROXIMAL THIRD IN THE RIGHT LEG. A RETROGRADE APPROACH WAS USED AND PRE- AND POST-DILATATION WAS CONDUCTED WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) AND THE LESION WAS PREPARED USING ATHERECTOMY. ON THE (B)(6) 2022, AN EVENT OF RESTENOSIS OF TREATED SEGMENT (TARGET LESION) WAS REPORTED FROM THE SITE. IT WAS REPORTED AS "POSSIBLY RELATED" TO THE DEVICE AND "NOT RELATED" TO THE PROCEDURE. THE PATIENT HAD AN ANGIOGRAM ON (B)(6) 2022 ON THE RIGHT LEG (TARGET LEG). FROM ULTRASOUND THERE WAS A 50-75% PROFUNDA AND PROXIMAL SFA STENOSIS. THE SFA STENT WAS PATENT WITH ELEVATED VELOCITIES IN THE MID AND DISTAL SECTIONS. DURING THE ANGIOGRAM HOWEVER ON (B)(6) 2022, THERE WAS EVIDENCE OF A HIGH-GRADE STENOSIS WITHIN THE SFA STENT. THE STENOSIS WAS TREATED WITH A PERCUTANEOUS INTERVENTION AND IT INVOLVED A TARGET LESION REVASCULARISATION ON (B)(6) 2022 WITH PTA BALLOON ANGIOPLASTY AND LASER ATHERECTOMY. POST INTERVENTION ANGIOGRAM AND INTRAVASCULAR ULTRASOUND (IVUS) SHOWED

  Patient problems: Restenosis

  MAUDE report 15556153 ↗
• 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 (6.0 X 80MM STENT) TO TREAT A DENOVO LESION OF THE SFA MIDDLE THIRD 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 ATHERECTOMY. ON THE (B)(6) 2022, AN EVENT OF RESTENOSIS OF TREATED VESSEL (TARGET VESSEL) 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 NOT TARGET LESION RELATED. ON (B)(6) 2022 THE SITE PROVIDED AN UPDATE TO THE EVENT THAT HIGHLIGHTED THE EVENT LED TO A PERCUTANEOUS INTERVENTION AND IT INVOLVED A TARGET LESION REVASCULARISATION ON (B)(6) 2022 WITH LASER ATHERECTOMY. 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: Pain; Restenosis

  MAUDE report 15460707 ↗
• MalfunctionMay 23, 2022Material Deformation; Material Deformation

  ON (B)(6) 2022, A PHYSICIAN REPORTED THAT DURING IMPLANTATION OF ONE BIOMIMICS 3D STENT THE LEADING EDGE OF THE STENT AT THE DISTAL END WAS MANGLED (DISTORTED) ON DEPLOYMENT.

  Patient problems: Insufficient Information; Stenosis

  MAUDE report 14468713 ↗