BioMimics 3D Vascular Stent System 142122-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 05391526850398), received between Feb 8, 2022 and Jan 29, 2026 — classified as 18 injuries, 2 malfunctions.

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

• MalfunctionJan 29, 2026Fracture

  IT WAS FURTHER REPORTED THAT ON (B)(6) 2025, A 6X60 MM BIOMIMICS 3D STENT THAT WAS SUCCESSFULLY PLACED IN THE RIGHT DISTAL SFA/POPLITEAL ARTERY OF A PATIENT. FEEDBACK WAS GIVEN THAT NO RESISTANCE OR ISSUES WERE ENCOUNTERED DURING THE DEPLOYMENT OF THE DEVICE. IT WAS ALSO NOTED THAT THE BIOMIMICS 3D STENT PATTERN WAS IN GOOD CONDITION AND DID NOT DISPLAY ANY DISTORTION. GOOD RESULTS WERE ACHIEVED IN THE DEPLOYMENT PROCEDURE. A PATIENT HISTORY WAS PROVIDED BY THE COMPLAINT SITE. IT IS IMPORTANT TO NOTE THAT THE ENTIRE LENGTH OF THE RIGHT SFA/POPLITEAL ARTERY HAS BEEN TREATED WITH VARIOUS STENTS SINCE EARLY 2023 AS MEANS TO TREAT OCCLUSION. THIS TARGET SITE EXPERIENCED RE-OCCLUSION TWICE PRIOR TO THE IMPLANT OF THE BIOMIMICS 3D 6X60 MM STENT. ADDITIONALLY, THE PATIENT HAS A HISTORY OF CHRONIC HEART FAILURE, METASTATIC RENAL CANCER AND ADIPOSITY. ON (B)(6)2026, THE PATIENT PRESENTED WITH RIGHT LOWER LIMB PAIN. UPON INSPECTION, THE PHYSICIAN DETERMINED THAT THE RIGHT SFA HAD RE-OCCLUDED, AND THAT A POTENTIAL STENT FRACTURE WAS PRESENT. THE PHYSICIAN TREATED THE PATIENT BY PERFORMING A THROMBOLYSIS AND BY PLACING A COMPETITOR STENT OVER THE POTENTIALLY FRACTURED BIOMIMICS 3D STENT.

  Patient problems: Insufficient Information; Obstruction/Occlusion

  MAUDE report 24207085 ↗
• InjuryDec 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT RELATES TO MDR 3011632150-2024-00056. 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 100 MM STENT AND A 6.0 X 60 MM STENT (THE SUBJECT OF THIS REPORT) WERE USED TO TREAT A DENOVO LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) MIDDLE THIRD TO SFA DISTAL THIRD IN THE RIGHT LEG. A RETROGRADE APPROACH WAS USED AND THE LESION WAS PREPARED WITH ATHERECTOMY AND POST-DILATED WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON. ON (B)(6) 2023, THE SITE IDENTIFIED A RESTENOSIS OF TREATED SEGMENT (TARGET LESION). IT WAS REPORTED AS NOT RELATED TO THE DEVICE AND NOT RELATED TO THE PROCEDURE BUT DUE TO A WORSENING PRE-EXISTING CONDITION. IT REQUIRED PERCUTANEOUS INTERVENTION. IT WAS REPORTED AS TARGET LESION RELATED. THE INTERVENTION WAS PERFORMED ON (B)(6) 2023 ON THE SFA PROXIMAL THIRD TO DISTAL POPLITEAL SEGMENT. A NON-BM3D BARE METAL STENT WAS PLACED, PTA/STANDARD BALLOON ANGIOPLASTY AND LASER ATHERECTOMY WERE USED TO TREAT THE RESTENOSIS. IT WAS A TARGET LESION/VESSEL REVASCULARISATION (TLR/TVR). THE SITE REPORTED "PRE-TREATMENT - RIGHT SFA: 81.4

  Patient problems: Restenosis

  MAUDE report 20833013 ↗
• InjuryOct 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS RELATED TO MDR NUMBER 3011632150-2024-00049_01. THIS PATIENT WAS ENROLLED IN THE MIMICS 3D USA POST-MARKET OBSERVATIONAL REGISTRY STUDY. ON (B)(6) 2022, THE PATIENT WAS IMPLANTED WITH TWO BIOMIMICS 3D (BM3D) STENTS. A 6.0 X 150 MM STENT (THE SUBJECT OF THIS REPORT) WAS USED TO TREAT A DENOVO LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) DISTAL THIRD AND A 6.0 X 60 MM STENT WAS USED TO TREAT A DENOVO LESION IN THE PROXIMAL POPLITEAL. BOTH STENTS WERE PLACED IN THE RIGHT LEG. A CONTRALATERAL APPROACH WAS USED AND THE LESIONS WERE PRE-DILATED WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). THE TREATED SEGMENTS WERE POST-DILATED WITH PTA. ON THE (B)(6) 2022, THE SITE IDENTIFIED A RESTENOSIS OF TREATED SEGMENT (TARGET LESION). 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 NOT SERIOUS. IT WAS REPORTED AS TARGET LESION RELATED. THE PATIENT HAD RECURRENT BILATERAL CLAUDICATION, A REPEAT ANGIOGRAM DONE ON (B)(6) 2022 SHOWED MODERATE-TO-SEVERE IN-STENT RESTENOSIS IN THE RANGE OF 70 - 80% IN SFA. IT WAS MANAGED MEDICALLY. AN UPDATE ON (B)(6) 2024 REPORTED THAT DURING A CLINIC VISIT WIT

  Patient problems: Pain; Restenosis; Swelling/ Edema

  MAUDE report 20343850 ↗
• InjuryJul 18, 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 26-MAY-21, THE PATIENT WAS IMPLANTED WITH ONE 6.0 X 60 MM BIOMIMICS 3D (BM3D) STENT, WHICH WAS USED TO TREAT A RESTENOTIC LESION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) DISTAL THIRD TO PROXIMAL POPLITEAL IN THE LEFT LEG. A RETROGRADE APPROACH WAS USED AND THE LESION WAS PREPARED USING PREDILATION WITH DRUG COATED/ELUTING BALLOON PRE-STENT PLACEMENT AND ATHERECTOMY. THE TREATED SEGMENT WAS POST-DILATED WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). ON 03-MAY-22, AN OCCLUSION WAS IDENTIFIED BY THE SITE. IT WAS REPORTED AS DEFINITELY RELATED TO THE DEVICE AND NOT RELATED TO THE PROCEDURE. IT WAS TARGET LESION RELATED. AT THE PATIENT'S 12-MONTH DUPLEX ULTRASOUND (DUS) ON 03-MAY-22, IT SHOWED MODERATE IN-STENT STENOSIS OF PROXIMAL LEFT SFA AND SEVERE IN-STENT STENOSIS OF DISTAL LEFT SFA. THE PATIENT ROUTINELY EXPERIENCED DISCOLORATION, SWELLING, ITCHING AND DISCOMFORT THAT CAN ALSO BE RELATED TO HER VENOUS ISSUES AND HAD A HISTORY OF DEEP VEIN THROMBOSIS (DVT) IN THIS LEG. THE PATIENT'S CLAUDICATION INCREASED FROM RUTHERFORD 1 TO 3 BETWEEN 03-MAY-22 AND 08-MAY-23. OF NOTE, THE PATIENT WAS DIAGNOS

  Patient problems: Discomfort; Itching Sensation; Obstruction/Occlusion; Pain; Skin Discoloration; Swelling/ Edema

  MAUDE report 19770301 ↗
• InjuryApr 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS ENROLLED IN THE MIMICS 3D USA POST-MARKET OBSERVATIONAL STUDY. ON (B)(6) 2021, THE PATIENT WAS IMPLANTED WITH ONE BIOMIMICS 3D (BM3D) 6.0 X 60 MM STENT TO TREAT A RESTENOTIC LESION IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA) PROXIMAL THIRD. AN ANTEGRADE APPROACH WAS USED AND THE LESION WAS PRE-DILATED WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) AND ATHERECTOMY. A NON-BM3D BARE METAL STENT WAS ALSO PLACED AFTER THE BM3D STENT IMPLANTATION. ON (B)(6) 2022, A RESTENOSIS OF THE TREATED SEGMENT (TARGET LESION) WAS IDENTIFIED AND IT WAS REPORTED AS POSSIBLY RELATED TO THE DEVICE AND NOT RELATED TO THE PROCEDURE. IT WAS TARGET LESION-RELATED. IT REQUIRED LASER ATHERECTOMY AND DRUG COATED/ELUTING BALLOON (DCB/DEB) OF THE RIGHT PROXIMAL SFA ON (B)(6) 2022. THE INTERVENTION WAS A TARGET LESION/VESSEL REVASCULARISATION (TLR/TVR). THE OUTCOME WAS REPORTED AS RESOLVED/RECOVERED. THE DEVICE REMAINS IMPLANTED. VERYAN BECAME AWARE OF THIS EVENT ON 13-MAR-24.

  Patient problems: Restenosis

  MAUDE report 19088625 ↗
• InjuryFeb 19, 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) 2021, THE PATIENT WAS IMPLANTED WITH ONE BIOMIMICS 3D (BM3D) STENT IN THE RIGHT LEG, A 6.0 X 60 MM STENT WHICH WAS USED TO TREAT A DENOVO LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) DISTAL THIRD TO PROXIMAL POPLITEAL ARTERY. A RETROGRADE APPROACH WAS USED AND THE LESION WAS PREPARED USING PRE-DILATION WITH A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON AND ATHERECTOMY. THE SITE IDENTIFIED A RESTENOSIS OF TREATED SEGMENT (TARGET LESION) EVENT ON 29-JUL-21. A 90% STENOSIS WITHIN THE STENT OF THE SFA WAS IDENTIFIED. IT WAS REPORTED AS POSSIBLY RELATED TO THE DEVICE AND NOT RELATED TO THE PROCEDURE. IT WAS TARGET LESION-RELATED. THE INTERVENTION INVOLVED A BARE METAL STENT PLACEMENT, DRUG COATED/ELUTING BALLOON (DCB/DEB), PTA/STANDARD BALLOON ANGIOPLASTY AND LASER ATHERECTOMY ON THE SFA MIDDLE THIRD TO DORSALIS PEDIS. IT 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 18729904 ↗
• InjuryJan 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS RELATED TO MDR NUMBER 3011632150-2023-00146. 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 AND A 6.0 X 60 MM BM3D (THE SUBJECT OF THIS REPORT) 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 (B)(6) 2023 WHICH SHOWED THAT THE ENTIRE SFA THAT HAD PREVIOUSLY BEEN STENTED HAD SIGNIFICANT STENOSIS THROUGHOUT THE ENTIRE REGION. THE PROXIMAL POPLITEAL SEGMENT ALSO SH

  Patient problems: Pain; Restenosis; Swelling/ Edema

  MAUDE report 18496827 ↗
• InjurySep 28, 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 IN THE RIGHT LEG, A 6.0 X 60 MM STENT WHICH WAS USED TO TREAT A DENOVO LESION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) DISTAL THIRD TO PROXIMAL POPLITEAL. 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 STUDY DEVICE AND NOT RELATED TO THE STUDY PROCEDURE. IT WAS REPORTED AS BEING DUE TO A WORSENING PRE-EXISTING CONDITION. IT WAS TARGET LESION RELATED. THE RIGHT SFA IN-STENT RESTENOSIS (ISR) WAS TREATED WITH ATHERECTOMY AND DRUG COATED BALLOON (DCB) ANGIOPLASTY. THE OUTCOME WAS REPORTED AS RESOLVED/RECOVERED. THE DEVICE REMAINS IMPLANTED. THE EVENT WAS REVIEWED BY VERYAN ON 30-AUG-23 AND CONSIDERED POSSIBLY RELATED TO THE DEVICE.

  Patient problems: Restenosis

  MAUDE report 17832626 ↗
• InjuryMay 17, 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 6.0 X 60MM STENT WHICH WAS USED TO TREAT A DENOVO LESION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) PROXIMAL 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. THE TREATED SEGMENT WAS ALSO POST-DILATED WITH PTA. THE SITE REPORTED THAT ON (B)(6) 2022, AN EVENT OF LIMB ISCHEMIA 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. A SEVERE IN-STENT STENOSIS WAS ALSO IDENTIFIED. IT WAS REVIEWED BY VERYAN'S CHIEF MEDICAL OFFICER ON (B)(6) 2023, THIS WAS CONSIDERED TO BE POSSIBLY RELATED TO THE DEVICE. THE LIMB ISCHEMIA WAS TREATED WITH A SURGICAL GRAFT BYPASS AND ENDARTERECTOMY OF THE SFA PROXIMAL THIRD AND DISTAL POPLITEAL ARTERY ON 06-OCT-22. IT WAS REPORTED AS A TARGET VESSEL REVASCULARISATION (TVR). THE PATIENT OUTCOME WAS REPORTED AS RESOLVED WITH SEQUELAE AND THE DEVICE REMAINS IMPLANTED.

  Patient problems: Ischemia; Restenosis

  MAUDE report 16947229 ↗
• InjuryApr 13, 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 BIOMIMICS 3D (BM3D) STENT, A 6.0 X 60MM STENT WHICH WAS USED TO TREAT A DENOVO LESION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) DISTAL THIRD IN THE RIGHT LEG. AN ANTEGRADE APPROACH WAS USED AND THE LESION WAS PREPARED USING PRE-DILATION WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON, CUTTING BALLOON AND SHOCKWAVE TREATMENTS. 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. THE PATIENT WAS SEEN AT THE CLINIC, REPORTING ACHING IN HER RIGHT FOOT INTERMITTENTLY WHILE WALKING, BUT IT WAS ALSO BILATERALLY WITH THE RIGHT LEG WORSE THAN THE LEFT LEG. PAIN WAS NOT DEBILITATING AND DID NOT INTERFERE WITH ACTIVITIES OF DAILY LIVING. THE PATIENT HAD PERIPHERAL ARTERIAL DISEASE RUTHERFORD CLASS IV/V WITH REST PAIN/WOUND POSSIBLY OF MUSCULOSKELETAL ETIOLOGY AS THE PAIN WAS EXACERBATED WITH PRESSURE. THERE WAS A NEW WOUND ON THE LATERAL ASPECT OF THE PATIENT'S RIGHT HALLUX WHICH WAS DRAINED. THE RIGHT FOOT WAS WARM WITH INTACT MOTOR FUNCTION. THE PAT

  Patient problems: Pain; Restenosis

  MAUDE report 16733122 ↗
• InjuryMar 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS RELATED TO MDR NUMBER 3011632150-2023-00032. 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 6.0 X 60 MM STENT (THE SUBJECT OF THIS REPORT) WAS USED TO TREAT A DENOVO LESION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) PROXIMAL THIRD TO MIDDLE THIRD SEGMENT AND A 6.0 X 100 MM BM3D STENT WAS USED TO TREAT A DENOVO LESION IN THE SFA MIDDLE THIRD TO DISTAL THIRD IN THE RIGHT LEG. A RETROGRADE APPROACH WAS USED AND THE LESIONS WERE PREPARED USING ATHERECTOMY AND PRE-DILATED WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). THE TREATED SEGMENTS WERE ALSO POST-DILATED WITH PTA. THE SITE REPORTED THAT ON 18-JAN-23, 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 THE CLINIC ON (B)(6) 2023 FOR RECURRENT DISCOMFORT IN THE RIGHT LEG. AN ULTRASOUND SHOWED A LIKELY IN-STENT RESTENOSIS. AN ENDOVASCULAR PROCEDURE WAS CONDUCTED ON (B)(6) 2023. THERE WAS A HIGH-GRADE STENOSIS MEASURING 66.9% JUST PROXIMAL TO THE PROXIM

  Patient problems: Discomfort; Restenosis

  MAUDE report 16516351 ↗
• InjuryFeb 20, 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 6.0 X 60MM BIOMIMICS 3D (BM3D) STENT TO TREAT A DENOVO LESION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) DISTAL THIRD TO PROXIMAL POPLITEAL SEGMENT IN THE LEFT LEG. AN ANTEGRADE 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. 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 ATTENDED CLINIC WITH LEFT FOOT REST PAIN. THE LEFT SFA OSTIAL TO THE PROXIMAL POPLITEAL SEGMENT (INCLUDING TARGET LESION) WAS TREATED WITH DRUG COATED BALLOON/DRUG ELUTING BALLOON (DCB/DEB) ANGIOPLASTY AND LASER ATHERECTOMY ON (B)(6) 2022. 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 REMAIN

  Patient problems: Pain; Restenosis

  MAUDE report 16403924 ↗
• InjuryJan 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS MDR REPORT IS RELATED TO MDR NUMBER 3011632150-2023-00017. 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 125 MM STENT AND A 6.0 X 60MM STENT (THE SUBJECT OF THIS REPORT) 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 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 BOTH

  Patient problems: Pain; Restenosis

  MAUDE report 16239840 ↗
• 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 3011632150-2023-00002. 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 STENTS. ONE A 5.0 X 125MM STENT AND A 6.0 X 60MM (THE SUBJECT OF THIS REPORT) 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 CON

  Patient problems: Pain; Restenosis

  MAUDE report 16172812 ↗
• 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 60MM BIOMIMICS 3D (BM3D) STENT TO TREAT A DENOVO LESION OF THE PROXIMAL POPLITEAL ARTERY 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. THE PATIENT ATTENDED CLINIC WITH INCREASED CLAUDICATION SYMPTOMS IN THE RIGHT LOWER EXTREMITY ON (B)(6) 2022. AN ULTRASOUND SHOWED IN STENT STENOSIS AND 50-75% STENOSIS THROUGHOUT OTHER PARTS OF THE VESSEL. AN ANGIOGRAM WAS DONE ON (B)(6) 2022 WHICH SHOWED SEVERAL AREAS OF IN STENT STENOSIS WITH INTIMAL HYPERPLASIA IN BOTH PROXIMAL AND DISTAL STENT (WORSE IN THE PROXIMAL STENT). THE POPLITEAL ARTERY WAS SEVERELY DISEASED WITH AN OCCLUSION IN THE P2 SEGMENT. THE INTERVENTION ON (B)(6) 2022 CONSISTED OF PTA/STANDARD BALLOON ANGIOPLASTY AND LASER ATHERECTOMY ON THE COMMON FEMORAL ARTERY TO THE DISTAL THIRD POSTERIOR TIBIAL ARTERY AND WAS REPORTED AS A

  Patient problems: Pain; Restenosis

  MAUDE report 15978865 ↗
• InjuryNov 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS MDR REPORT IS RELATED TO MDR NUMBER 3011632150-2022-00097. THE PATIENT WAS TREATED AS PART OF THE MIMICS 3D USA POST-MARKET OBSERVATIONAL STUDY ON (B)(6) 2022. THE SUBJECT WAS IMPLANTED WITH TWO BIOMIMICS 3D (BM3D) STENTS (ONE 6.0 X 60MM STENT AND ONE 6 X 100MM STENT) TO TREAT A DENOVO LESION OF THE SFA PROXIMAL THIRD TO MIDDLE THIRD AND SFA MIDDLE THIRD TO DISTAL THIRD ARTERY 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. IT WAS ALSO REPORTED AS TARGET LESION RELATED. THE PATIENT ATTENDED FOR AN OFFICE VISIT, COMPLAINING OF RECURRENT CLAUDICATION SYMPTOMS IN HER RIGHT LEG . AN ULTRASOUND SHOWED CONCERN FOR RECURRENT STENOSIS WITHIN THE DISTAL RIGHT SUPERFICIAL FEMORAL ARTERY. ON (B)(6) 2022, THE PATIENT HAD AN ANGIOGRAM WHICH REVEALED TWO AREAS OF CRITICAL STENOSIS AT THE PROXIMAL END OF THE PROXIMAL RIGHT SFA STENT AS WELL AS AT THE DISTAL END OF

  Patient problems: Pain; Restenosis

  MAUDE report 15778232 ↗
• InjurySep 5, 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 60MM STENT) TO TREAT A DENOVO LESION OF THE PROXIMAL POPLITEAL ARTERY IN THE LEFT LEG. A CONTRALATERAL 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. 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, PTA BALLOON ANGIOPLASTY AND LASER ATHERECTOMY. THE DEVICE REMAINS IMPLANTED. THE PATIENT OUTCOME IS REPORTED AS "RESOLVED/RECOVERED".

  Patient problems: Restenosis

  MAUDE report 15355441 ↗
• MalfunctionJul 29, 2022Failure to Advance; Positioning Problem; Failure to Advance; Positioning Problem

  ON (B)(6) 2022 A PATIENT ENROLLED IN THE MIMICS 3D USA POST MARKET REGISTRY STUDY WAS TREATED FOR TWO DE NOVO LESIONS. THE FIRST LESION AFFECTED THE SFA MIDDLE THIRD TO DISTAL THIRD IN THE RIGHT LEG. A BIOMIMICS 3D (BM3D) 6.0 X 80MM STENT WAS USED TO TREAT THIS LESION SUCCESSFULLY. A CONTRALATERAL APPROACH WAS USED AND THE TARGET SITE WAS PRE-DILATED AND POST DILATED WITH BALLOON ANGIOPLASTY AND ATHERECTOMY AND DRUG COATED BALLOON (DCB) ANGIOPLASTY WAS USED BEFORE THE BM3D STENT WAS IMPLANTED. THE SECOND DE NOVO LESION REQUIRED A BM3D 6 X 60MM STENT PLACEMENT (THE SUBJECT OF THIS REPORT) IN THE MORE DISTAL PROXIMAL POPLITEAL ARTERY IN THE SAME LEG. DURING ADVANCEMENT OF THIS DEVICE THROUGH THE ALREADY PLACED 6 X 80MM STENT, THE LIP OF THE SHEATH IS REPORTED BY THE PHYSICIAN TO HAVE CAUGHT A PORTION OF THE 6 X 80MM STENT AND DISRUPTED (CRUSHED) THE PROXIMAL END OF THE STENT. THE BM3D 6 X 60MM DELIVERY SYSTEM WAS REMOVED. A COMPETITOR BARE METAL STENT WAS USED TO RESOLVE THE CRUSHED PROXIMAL END OF THE 6 X 80MM STENT AND ANOTHER BM3D 6 X 60MM DEVICE WAS ADVANCED TO THE TARGET SITE AND DEPLOYED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15128268 ↗
• InjuryMar 23, 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 DISTAL THIRD OF THE LEFT LEG. AN EVENT OF RESTENOSIS OF TREATED SEGMENT (TARGET LESION) WAS ORIGINALLY REPORTED TO VERYAN ON 25 FEB 2022 AS "DEFINITELY RELATED" TO THE DEVICE. IT WAS REPORTED AS TARGET LESION RELATED. IT WAS IDENTIFIED ON (B)(6) 2022 WHEN THE PATIENT PRESENTED FOR AN ULTRASOUND DUE TO EXPERIENCING WORSENING CLAUDICATION. THE OUTCOME OF THE EVENT IS REPORTED AS RESOLVED/RECOVERED. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Pain; Restenosis

  MAUDE report 13868033 ↗
• InjuryFeb 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS MDR IS RELATED TO MDR NUMBER 3011632150-2022-00004. THERE IS NO EVIDENCE TO SUGGEST THAT THE DEVICE CAUSED OR CONTRIBUTED TO THIS EVENT. THE PATIENT WAS TREATED AS PART OF THE (B)(6) STUDY ON (B)(6) 2021. THE SUBJECT WAS IMPLANTED WITH TWO BIOMIMICS 3D STENTS IN THE SFA OSTIAL TO PROXIMAL POPLITEAL ARTERY IN THE LEFT LEG. THE SITE REPORTED AN OCCLUSION WITH A DATE OF ONSET (B)(6) 2021. THE OCCLUSION WAS REPORTED AS RELATED TO A WORSENING PRE-EXISTING CONDITION AND NOT RELATED TO THE DEVICE OR PROCEDURE. ON (B)(6) 2021 THE OCCLUSION OF THE SFA PROXIMAL THIRD TO PROXIMAL POPLITEAL ARTERY OF THE LEFT LEG WAS TREATED WITH A GRAFT/BYPASS AS MULTIPLE ATTEMPTS TO CROSS THE OCCLUSION WERE NOT SUCCESSFUL. THE EVENT IS RESOLVED AND THE PATIENT HAS RECOVERED. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 13481582 ↗