BioMimics 3D Vascular Stent System 142122-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 05391526850459), received between Oct 26, 2021 and Dec 3, 2024 — classified as 27 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 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 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• InjuryDec 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED ON THE 07-MAY-25 REGARDING THE PROCEDURE, THE COMMENTS PROVIDED BY THE SITE WERE "THE RIGHT SFA - POP IN STENT RESTENOSIS REVASC OF DISTAL SFA WITH LASER ATHERECTOMY AND DCB. SEVERE STENOSIS OF GREATER THAN 90% IN THE RIGHT TPT TRUNK REVAS WITH LASER ATHERECTOMY AND POBA". ADDITIONAL INFORMATION WAS RECEIVED FROM THE SITE AND REVIEWED BY VERYAN ON 27-MAY-25 AT THE SAFETY MONITORING MEETING (SMR) WHERE THE PREVIOUSLY REPORTED EVENT OF RESTENOSIS OF THE TREATED SEGMENT VESSEL (TARGET LESION) EVENT WAS UPDATED AS A TARGET LESION REVASCULARIZATION (TVR) AND THE UPDATED DETAILS OF THE INTERVENTION WITH AN UPDATE TO THE TLR FIELD, THE EVENT IS STILL DEEMED REPORTABLE FOLLOWING REVIEW AT PREVIOUS SMR, A SUPPLEMENTAL IS REQUIRED TO CAPTURE THIS UPDATE.

  Patient problems: Restenosis

  MAUDE report 20833086 ↗
• InjuryJan 31, 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 LEFT LEG, A 6.0 X 100 MM STENT WHICH WAS USED TO TREAT A DENOVO LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) MIDDLE THIRD. A RETROGRADE APPROACH WAS USED AND THE LESION WAS PREPARED USING PRE-DILATION WITH A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON AND ATHERECTOMY. THE TREATED SEGMENT WAS POST-DILATED WITH PTA. ON (B)(6) 2022, AT THE PATIENT'S 12-MONTH DUPLEX ULTRASOUND (DUS), IT SHOWED SEVERELY ELEVATED VELOCITIES OF THE LEFT PROXIMAL AND MID SFA. THE SITE IDENTIFIED A RESTENOSIS OF TREATED VESSEL (TARGET VESSEL) EVENT WHEN THE PATIENT WAS SEEN IN THE CLINIC ON (B)(6) 2022 WHERE RUTHERFORD CLASS III SYMPTOMS WERE NOTED. 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. A DIAGNOSTIC ANGIOGRAPHY ON (B)(6) 2022 FOUND A SEVERELY CALCIFIED LESION JUST ABOVE THE TARGET LESION IN THE PROXIMAL TO MID SFA WITH STENOSIS OF GREATER THAN 70%. A LEFT LEG INTERVENTION WAS PERFORMED ON (B)(6) 2022 AND INV

  Patient problems: Pain; Restenosis

  MAUDE report 18612714 ↗
• InjuryJan 25, 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 LEFT LEG, A 6.0 X 100 MM STENT WHICH WAS USED TO TREAT A DENOVO LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) MIDDLE THIRD TO SFA DISTAL THIRD. A RETROGRADE APPROACH WAS USED AND THE LESION WAS PREPARED USING PRE-DILATION WITH A 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) EVENT ON (B)(6) 2022. IT WAS REPORTED AS DEFINITELY RELATED TO THE DEVICE AND NOT RELATED TO THE PROCEDURE. IT WAS TARGET LESION RELATED. THIS WAS TREATED ON (B)(6) 2022, WITH PTA / STANDARD BALLOON ANGIOPLASTY AND LASER/ATHERECTOMY WHICH WERE PERFORMED ON THE SFA PROXIMAL THIRD TO PROXIMAL POPLITEAL ARTERIAL SEGMENT. THE INTERVENTION WAS REPORTED AS 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 28-DEC-2023 AND IT WAS REVIEWED BY VERYAN IN JAN 2024 AND CONSIDERED RELATED TO THE DEVICE.

  Patient problems: Restenosis

  MAUDE report 18581537 ↗
• InjuryDec 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS RELATED TO MDR REPORT: 3011632150-2023-00139. 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 6.0 X 100MM BIOMIMICS 3D (BM3D) STENTS, WHICH WERE USED TO TREAT A DENOVO LESION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) DISTAL THIRD TO PROXIMAL POPLITEAL ARTERY 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 ALSO POST-DILATED WITH PTA. ON (B)(6) 2022, A RESTENOSIS OF TREATED VESSEL (TARGET VESSEL) WAS IDENTIFIED. IT WAS REPORTED AS POSSIBLY RELATED TO THE DEVICE AND NOT RELATED TO THE PROCEDURE. IT WAS NOT TARGET LESION RELATED. IT REQUIRED PERCUTANEOUS INTERVENTION ON THE MID PART OF THE RIGHT SFA. THE INTERVENTION WAS PERFORMED ON (B)(6) 2023 AND INVOLVED NON BM3D BARE METAL STENT PLACEMENT, DRUG COATED/ELUTING BALLOON (DCB/DEB), PTA/STANDARD BALLOON ANGIOPLASTY AND LASER ATHERECTOMY ON THE SFA OSTIAL TO DISTAL POPLITEAL ARTERIAL SEGMENT. THE INTERVENTION WAS REPORTED AS A TARGET LESION/VESSEL REVASCULARISATION (TLR/TVR). THE PATIENT OU

  Patient problems: Restenosis

  MAUDE report 18271578 ↗
• InjuryDec 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS RELATED TO MDR REPORT 3011632150-2023-00138. 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 6.0 X 100MM BIOMIMICS 3D (BM3D) STENTS, WHICH WERE USED TO TREAT A DENOVO LESION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) DISTAL THIRD TO PROXIMAL POPLITEAL ARTERY 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 ALSO POST-DILATED WITH PTA. ON THE (B)(6) 2022, A RESTENOSIS OF TREATED VESSEL (TARGET VESSEL) WAS IDENTIFIED. IT WAS REPORTED AS POSSIBLY RELATED TO THE DEVICE AND NOT RELATED TO THE PROCEDURE. IT WAS NOT TARGET LESION RELATED. IT REQUIRED PERCUTANEOUS INTERVENTION ON THE MID PART OF THE RIGHT SFA. THE INTERVENTION WAS PERFORMED ON (B)(6) 2023 AND INVOLVED NON BM3D BARE METAL STENT PLACEMENT, DRUG COATED/ELUTING BALLOON (DCB/DEB), PTA/STANDARD BALLOON ANGIOPLASTY AND LASER ATHERECTOMY ON THE SFA OSTIAL TO DISTAL POPLITEAL ARTERIAL SEGMENT. THE INTERVENTION WAS REPORTED AS A TARGET LESION/VESSEL REVASCULARISATION (TLR/TVR). THE PAT

  Patient problems: Restenosis

  MAUDE report 18271577 ↗
• InjuryNov 24, 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 100 MM BIOMIMICS 3D (BM3D) STENT IN THE LEFT LEG TO TREAT A RESTENOTIC LESION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) MIDDLE THIRD. A RETROGRADE APPROACH WAS USED AND THE LESION WAS PREPARED WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON AND ATHERECTOMY. THE TREATED SEGMENT WAS POST-DILATED WITH A PTA BALLOON. THE SITE IDENTIFIED A RESTENOSIS OF TREATED SEGMENT (TARGET LESION) ON (B)(6) 2022. IT WAS REPORTED AS DEFINITELY RELATED TO THE STUDY DEVICE AND NOT RELATED TO THE STUDY PROCEDURE. IT WAS TARGET LESION RELATED. DUPLEX ULTRASOUND (DUS) PERFORMED ON (B)(6) 2022 SHOWED AN OCCLUDED LEFT DISTAL SFA AND POPLITEAL ARTERY. THE SUBJECT WAS REFERRED FOR AN EVALUATION FOR A FEMOROPOPLITEAL BYPASS. ON (B)(6) 2022, THIS WAS ATTEMPTED BUT THE PROCEDURE WAS ABORTED DUE TO AN INABILITY TO GAIN ACCESS TO ANY LUMEN TO EVALUATE THE OUTFLOW IN THE VESSELS BELOW THE KNEE. ON (B)(6) 2022, INTERVENTIONAL CARDIOLOGY PERFORMED A LIMB SALVAGE PROCEDURE. LASER ATHERECTOMY AND BALLOON ANGIOPLASTY (DRUG COATED/ELUTING BALLOON (DCB/DEB) AND PTA/STANDARD

  Patient problems: Restenosis

  MAUDE report 18204607 ↗
• 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 THE (B)(6) 21, THE PATIENT WAS IMPLANTED WITH ONE BIOMIMICS 3D (BM3D) STENT, A 6.0 X 100 MM STENT WHICH WAS USED TO TREAT A RESTENOTIC LESION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) DISTAL THIRD TO PROXIMAL POPLITEAL 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. ON THE (B)(6) 21, AN EVENT OF OCCLUSION, EARLY (7 - 30 DAYS TREATED VESSEL) WAS IDENTIFIED BY THE SITE. IT WAS REPORTED AS NOT RELATED TO THE DEVICE OR PROCEDURE BUT DUE TO A WORSENING OF THE PATIENT'S PRE-EXISTING CONDITION. IT WAS TARGET LESION RELATED. IT REQUIRED SURGICAL INTERVENTION.DURING A PROCEDURE ON THE RIGHT LEG EXTREMITY (RLE) ON (B)(6) 21, A LEFT ANGIOGRAM WAS PERFORMED WHICH SHOWED THE SFA WAS WIDELY PATENT BUT THE POPLITEAL OCCLUDED ABOVE THE KNEE AND RECONSTITUTED BELOW KNEE. A BYPASS OF THE LEFT FEMORAL-BELOW KNEE POPLITEAL WAS PERFORMED ON (B)(6) 21. THE GRAFT/BYPASS INVOLVED THE SEGMENT BETWEEN THE SFA DISTAL THIRD AND PROXIMAL POPLITEAL ARTERY. IT WAS REPORTED AS A TARGET LESION/VESSEL

  Patient problems: Obstruction/Occlusion

  MAUDE report 18007742 ↗
• InjuryOct 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS RELATED TO MDR NUMBER 3011632150-2023-00090. 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 60 MM STENT WAS USED TO TREAT A DENOVO LESION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) OSTIAL TO PROXIMAL THIRD IN THE LEFT LEG. THE PATIENT ALSO HAD A 6.0 X 100MM BM3D STENT (THE SUBJECT OF THIS REPORT) PLACED IN THE LEFT SFA DISTAL THIRD TO PROXIMAL POPLITEAL SEGMENT ON (B)(6) 2022 FOR A RESTENOSIS. A SECOND NON-STUDY COMMERCIAL BM3D 7.0 X 150 MM STENT WAS IMPLANTED IN THIS PATIENT ON (B)(6) 22 FOR A RESTENOSIS EVENT IN THE SFA MIDDLE THIRD. A CONTRALATERAL APPROACH WAS USED AND THE LESIONS WERE PREPARED USING STANDARD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) AND ATHERECTOMY. THE TREATED SEGMENTS WERE ALSO 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. AN IN-STENT RESTENOSIS (ISR) WAS SEEN ON DUPLEX ULTRASOUND (DUS) ON (B)(6) 2023. IT WAS ALSO REPORTED AS TARGET LESION RELATED. AN INTERVENTI

  Patient problems: Restenosis

  MAUDE report 17922546 ↗
• InjuryOct 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS RELATED TO MDR REPORT 3011632150-2024-00015 AND 3011632150-2022-00106. 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 7.0 X 60MM BIOMIMICS 3D (BM3D) STENT (THE SUBJECT OF REPORT 3011632150-2022-00106). THIS WAS USED TO TREAT A DENOVO LESION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) OSTIAL TO SFA PROXIMAL THIRD IN THE LEFT LEG. THE PATIENT ALSO HAD A 6.0 X 100MM BM3D STENT (THE SUBJECT OF THIS REPORT) PLACED IN THE LEFT SFA DISTAL THIRD TO PROXIMAL POPLITEAL SEGMENT ON (B)(6) 2022 FOR A RESTENOSIS. ON (B)(6) 2024, ADDITIONAL INFORMATION WAS RECEIVED BY VERYAN WHERE THE SITE ADDED DETAILS OF A SECOND NON-STUDY COMMERCIAL BM3D STENT (A 7.0 X 150 MM STENT (THE SUBJECT OF REPORT 3011632150-2024-00015) WHICH WAS PLACED ON (B)(6) 2022 IN THE SFA MIDDLE THIRD TO TREAT A RESTENOSIS EVENT OF THE COMMON FEMORAL TO SFA MIDDLE THIRD SEGMENT. ALL IMPLANTATIONS USED A CONTRALATERAL APPROACH AND THE LESIONS WERE PREPARED USING STANDARD PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) AND ATHERECTOMY. THE TREATED SEGMENTS WERE ALSO POST-DILATED WITH PTA. ON (B)(6) 2022, THE SITE IDENTIFIED A RESTEN

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

  MAUDE report 17922464 ↗
• InjuryMay 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS RELATED TO MDR REPORTS 3011632150-2023-00059 AND 3011632150-2023-00060. 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 100MM STENT (THE SUBJECT OF THIS REPORT) WHICH WAS USED TO TREAT A RESTENOTIC LESION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) MIDDLE 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. TWO ADDITIONAL BM3D STENTS, A 6.0 X 150MM STENT AND A 6.0 X 60MM STENT WERE PLACED IN THIS PATIENT ON (B)(6) 2022 TO TREAT A RESTENOSIS OF THE TREATED VESSEL. THEY WERE USED TO TREAT A DENOVO LESION IN THE PROXIMAL SFA AND OVERLAPPED WITH THE FIRST BM3D STENT IMPLANTED ON (B)(6) 2021. THE SITE REPORTED THAT ON (B)(6) 2023, AN OCCLUSION WAS IDENTIFIED. IT WAS REPORTED AS DEFINITELY RELATED TO THE DEVICE AND NOT RELATED TO THE PROCEDURE. IT WAS REPORTED AS TARGET LESION RELATED. THE PATIENT RETURNED FOR FOLLOW-UP DUPLEX ULTRASOUND (DUS) AND ANKLE BRACHIAL INDEX (ABI) ON (B)

  Patient problems: Ischemia; Obstruction/Occlusion; Pain; Skin Discoloration

  MAUDE report 16916428 ↗
• InjuryApr 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS RELATED TO MDR NUMBER 3011632150-2023-00054. THE PATIENT WAS ENROLLED IN THE MIMICS 3D USA POST-MARKET OBSERVATIONAL STUDY ON THE (B)(6) 2021. THEY WERE TREATED WITH TWO 6.0 X 100MM BIOMIMICS 3D (BM3D) STENTS TO TREAT A DENOVO LESION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) DISTAL THIRD TO PROXIMAL POPLITEAL SEGMENT IN THE RIGHT LEG. A CONTRALATERAL APPROACH WAS USED AND THE LESION WAS PREPARED USING PRE-DILATION WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) AND ATHERECTOMY. THE TREATED SEGMENT WAS ALSO POST-DILATED WITH PTA. ON THE (B)(6) 2022, THE SITE IDENTIFIED A RESTENOSIS OF TREATED SEGMENT (TARGET LESION). THE EVENT REQUIRED PERCUTANEOUS INTERVENTION. THE PATIENT PRESENTED TO THE CLINIC FOR A 12-MONTH VISIT WITH ABNORMAL ARTERIAL ULTRASOUND. A BILATERAL LEG EXTREMITY (BLE) DIAGNOSTIC ANGIOGRAM CONDUCTED ON (B)(6) 2023 SHOWED TARGET LESION RE-STENOSIS. THERE WAS A RE-INTERVENTION ON THE TARGET LIMB AND LESION COMPLETED ON (B)(6) 2023. IT INVOLVED NON BM3D BARE METAL STENT PLACEMENT OF THE RIGHT MID SFA EXTENDING INTO THE PROXIMAL PORTION OF THE STENT, DRUG COATED BALLOON/DRUG ELUTING BALLOON (DCB/DEB) AND PTA/STANDARD BALLOON ANGIOPLASTY OF THE SFA OSTIAL TO DISTAL

  Patient problems: Restenosis

  MAUDE report 16833415 ↗
• InjuryApr 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS RELATED TO MDR NUMBER 3011632150-2023-00055. THE PATIENT WAS ENROLLED IN THE MIMICS 3D USA POST-MARKET OBSERVATIONAL STUDY ON (B)(6) 2021. THEY WERE TREATED WITH TWO 6.0 X 100MM BIOMIMICS 3D (BM3D) STENTS TO TREAT A DENOVO LESION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) DISTAL THIRD TO PROXIMAL POPLITEAL SEGMENT IN THE RIGHT LEG. A CONTRALATERAL APPROACH WAS USED AND THE LESION WAS PREPARED USING PRE-DILATION WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) AND ATHERECTOMY. THE TREATED SEGMENT WAS ALSO POST-DILATED WITH PTA. ON (B)(6) 2022, THE SITE IDENTIFIED A RESTENOSIS OF TREATED SEGMENT (TARGET LESION). THE EVENT REQUIRED PERCUTANEOUS INTERVENTION. THE PATIENT PRESENTED TO THE CLINIC FOR A 12-MONTH VISIT WITH ABNORMAL ARTERIAL ULTRASOUND. A BILATERAL LEG EXTREMITY (BLE) DIAGNOSTIC ANGIOGRAM CONDUCTED ON (B)(6) 2023 SHOWED TARGET LESION RE-STENOSIS. THERE WAS A RE-INTERVENTION ON THE TARGET LIMB AND LESION COMPLETED ON (B)(6) 2023. IT INVOLVED NON BM3D BARE METAL STENT PLACEMENT OF THE RIGHT MID SFA EXTENDING INTO THE PROXIMAL PORTION OF THE STENT, DRUG COATED BALLOON/DRUG ELUTING BALLOON (DCB/DEB) AND PTA/STANDARD BALLOON ANGIOPLASTY OF THE SFA OSTIAL TO DISTAL POPLITEA

  Patient problems: Restenosis

  MAUDE report 16833250 ↗
• InjuryMar 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS RELATED TO MDR NUMBER 3011632150-2023-00031. 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 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 (THE SUBJECT OF THIS REPORT) 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 (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 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 PROX

  Patient problems: Discomfort; Restenosis

  MAUDE report 16516453 ↗
• InjuryMar 8, 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 100MM BIOMIMICS 3D (BM3D) STENT TO TREAT A DENOVO LESION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) OSTIAL TO SFA PROXIMAL THIRD 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. 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 AND INTERCURRENT INTERVENTION. IT WAS REPORTED AS TARGET LESION RELATED. THE EVENT OCCURRED IN THE TARGET LIMB AND INVOLVED AN IN-STENT TARGET LESION RESTENOSIS. THE LEFT SFA OSTIAL TO THE PROXIMAL POPLITEAL SEGMENT WAS TREATED WITH A NEW BM3D BARE METAL STENT PLACEMENT, PTA/STANDARD BALLOON ANGIOPLASTY AND LASER ATHERECTOMY ON (B)(6) 2022. THE EVENT ALSO INVOLVED A NON-TARGET LESION IN THE TARGET VESSEL AND A NON-TARGET VESSEL INTERVENTION. IT WAS REPORTED AS A TARGET LESION RE

  Patient problems: Restenosis

  MAUDE report 16503500 ↗
• InjuryDec 20, 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 THE (B)(6) 22, THE PATIENT WAS IMPLANTED WITH ONE BIOMIMICS 3D STENT (A 6 X 100MM STENT) 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. THE LESION WAS ALSO POST-DILATED WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). THE SITE REPORTED THAT ON (B)(6) 22, AN EVENT OF RESTENOSIS OF TREATED SEGMENT (TARGET LESION) WAS IDENTIFIED. THE PATIENT WHO HAS A MEDICAL HISTORY OF CHRONIC NEUROPATHY, ATTENDED THE CLINIC WITH COMPLAINTS OF LEFT LOWER EXTREMITY DISCOMFORT. THE PATIENT HAD A DUPLEX ULTRASOUND (DUS) OF BILATERAL LOWER EXTREMITIES. THE TARGET LIMB (LEFT LEG EXTREMITY (LLE)) SHOWED > 75% STENOSIS. IT WAS REPORTED AS TARGET LESION RELATED. IT WAS REPORTED AS DEFINITELY RELATED TO THE DEVICE. THE PATIENT WAS TREATED ON (B)(6) 22 WITH DRUG COATED BALLOON / DRUG ELUTING BALLOON (DCB/DEB) AND LASER ATHERECTOMY ON THE SFA MIDDLE THIRD TO DISTAL THIRD SEGMENT. THIS WAS REPORTED AS A TARGET LESION REVASCULARISATION(TLR)/TARGET VESSEL REVASCULARISATION (TVR). THE EVENT WAS REPORTED AS RESOLVED/RECOVE

  Patient problems: Discomfort; Restenosis

  MAUDE report 16016424 ↗
• InjuryDec 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS RELATED TO MDR REPORT 3011632150-2022-00113. 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 IN THE LEFT LEG TO TREAT DE NOVO LESIONS. ONE 6 X100MM STENT (THE SUBJECT OF THE REPORT) IN THE SUPERFICIAL FEMORAL ARTERY (SFA) PROXIMAL THIRD TO SFA DISTAL THIRD ARTERIAL SEGMENT AND ONE 6.0 X 125MM STENT IN THE SFA DISTAL THIRD TO PROXIMAL POPLITEAL ARTERIAL SEGMENT. A RETROGRADE APPROACH WAS USED AND THE LESIONS WERE PRE-DILATED AND POST-DILATED USING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). THE SITE REPORTED THAT THE PATIENT ATTENDED CLINIC WITH A PRE-EXISTING NON-HEALING WOUND ON (B)(6) 2022. AN ULTRASOUND SHOWED MILD IN-STENT RESTENOSIS IN THE SFA STENT. FOLLOWING AN ANGIOGRAM ON (B)(6) 2022, WHICH SHOWED MODERATE IN-STENT RESTENOSIS OF THE SFA STENT AND MODERATE STENOSIS OF THE POPLITEAL ARTERY. ON (B)(6) 2022, THE SFA PROXIMAL THIRD TO POSTERIOR TIBIAL MIDDLE THIRD SEGMENT WAS TREATED USING DRUG COATED BALLOON / DRUG ELUTING BALLOON (DCB/DEB), PTA / STANDARD BALLOON ANGIOPLASTY, AND LASER ATHERECTOMY. REPEAT ANGIOGRAPHY DEMONSTRATED SIGNIFICANT IMPROVEMENT

  Patient problems: Restenosis

  MAUDE report 15957920 ↗
• 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 100MM BIOMIMICS 3D (BM3D) STENT. THIS WAS USED TO TREAT A DE NOVO LESION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) MIDDLE THIRD TO SFA DISTAL THIRD IN THE RIGHT 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 SEVERE IN-STENT RESTENOSIS OF THE DISTAL SFA AND PROXIMAL POPLITEAL ARTERIES. ON THE SAME DAY, LASER ATHERECTOMY AND PTA ON THE SFA DISTAL THIRD AND PROXIMAL POPLITEAL WAS CONDUCTED. 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. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Restenosis

  MAUDE report 15932895 ↗
• 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 3011632150-2022-00096. 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 15778233 ↗
• InjurySep 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS RELATED TO MDRS 3011632150-2022-00078,AND -00079. THE PATIENT WAS TREATED AS PART OF THE MIMICS 3D USA POST-MARKET OBSERVATIONAL STUDY ON (B)(6) 2021. THE SUBJECT WAS IMPLANTED WITH THREE BIOMIMICS 3D (BM3D) STENT ( 6.0 X 150MM STENT (REPORT #3011632150-2022-00078), 6 X 150MM STENT (REPORT #3011632150-2022-00079) AND A 6 X 100MM (THIS REPORT)) TO TREAT A DENOVO LESION OF THE SFA PROXIMAL THIRD TO 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 IDENTIFIED BY 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(S) REMAIN IMPLANTED. THE PATIENT OUTCOME IS REPORTED AS "RESOLVED/RECOVERED".

  Patient problems: Restenosis

  MAUDE report 15355435 ↗
• InjurySep 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS RELATED TO MDR REPORT NUMBER 3011632150-2022-00077. 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 ( 6.0 X 100MM STENT (THIS REPORT) AND A 6.0 X 125MM STENT) TO TREAT A DENOVO LESION OF THE SFA PROXIMAL THIRD TO PROXIMAL POPLITEAL ARTERY IN THE LEFT LEG. A RETROGRADE APPROACH WAS USED AND PRE- AND POST-DILATATION WAS CONDUCTED WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) . ON THE (B)(6) 2022, AN EVENT OF RESTENOSIS OF TREATED SEGMENT (TARGET LESION) WAS IDENTIFIED BY THE SITE AND REPORTED BY THE SITE. THE PATIENT REPORTED LEFT LEG SWELLING AND WHEN ASSESSED AT THE CLINIC THE SITE IDENTIFIED NEW ONSET LEFT LEG PARESTHESIA. ARTERIAL DUPLEX ULTRASOUND (DUS) REVEALED: 50-75% STENOSIS IN COMMON ILIAC ARTERY (CIA) ; 50-75% STENOSIS IN DISTAL FEMORAL ARTERY (DFA) ; 50-75% STENOSIS IN MIDDLE SFA STENT; <50% STENOSIS IN DISTAL POPLITEAL ARTERY; NO FLOW VISUALIZED IN ANTERIOR TIBIAL ARTERY (ATA). IT WAS REPORTED AS "NOT RELATED" TO THE DEVICE AND "NOT RELATED" TO THE PROCEDURE BUT DUE TO WORSENING PRE-EXISTING CONDITION. IT WAS ALSO REPORTED AS TARGET LESION RELATED.

  Patient problems: Ischemia; Restenosis; Swelling/ Edema

  MAUDE report 15355427 ↗
• InjuryJul 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 100MM STENT) TO TREAT A DENOVO LESION OF THE SFA MIDDLE THIRD TO SFA DISTAL THIRD ARTERY IN THE RIGHT LEG. A CONTRALATERAL APPROACH WAS USED AND PRE-DILATATION AND POST-DILATATION OF THE TARGET LESION WAS CONDUCTED WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA), DRUG COATED BALLOON WAS ALSO USED PRE-BM3D PLACEMENT. ON (B)(6) 2022, AN EVENT OF RESTENOSIS OF TREATED SEGMENT (TARGET LESION) WAS REPORTED FROM THE SITE WHERE THE PATIENT PRESENTED WITH CLAUDICATION. 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 OUTCOME IS REPORTED AS "RESOLVED/RECOVERED". IT LED TO A TARGET LESION REVASCULARISATION ON (B)(6) 2022 AND IT INVOLVED A NON BM3D STENT, LASER ATHERECTOMY, DRUG COATED BALLOON ANGIOPLASTY AND SHOCKWAVE TREATMENTS. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Pain; Restenosis

  MAUDE report 15073287 ↗
• MalfunctionJul 19, 2022Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  A VERYAN REPRESENTATIVE WAS MADE AWARE OF A REPORT FROM A PHYSICIAN WHERE A 6 X 100MM BIOMIMICS 3D VASCULAR STENT SYSTEM WOULD NOT DEPLOY. THE TARGET SITE WAS THE DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) AND WAS PREPARED USING LASER ATHERECTOMY AND BALLOON ANGIOPLASTY. THERE WAS A TIGHT BIFURCATION ANGLE REPORTED. THERE WAS ALSO RESISTANCE FELT AT INITIATION OF DEPLOYMENT. THE DEVICE WAS REMOVED AND ANOTHER BIOMIMICS 3D STENT WAS USED TO FINISH THE PROCEDURE. THERE WAS RESISTANCE AT INITIATION OF DEPLOYMENT OF THE SECOND DEVICE BUT IT WAS DESCRIBED AS NOT NOTICABLE IN COMPARISON TO THE INITIAL DEVICE USED. THE DEVICE WAS NOT RETURNED FOR EVALUATION. THERE WAS NO IMPACT TO THE PATIENT AND THE PHYSICIAN REPORTED THE PATIENT OUTCOME AS GOOD. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO ANGIOGRAPHIC IMAGING WAS MADE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15050580 ↗
• InjuryJul 12, 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 6.0 X 100MM STENT) TO TREAT A DENOVO LESION OF THE SFA MIDDLE TO SFA DISTAL THIRD ARTERY IN THE RIGHT LEG. A RETROGRADE APPROACH WAS USED AND PRE-DILATATION AND POST-DILATATION OF THE TARGET LESION WAS CONDUCTED WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). ATHERECTOMY WAS ALSO PERFORMED PRE STENT PLACEMENT. 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 OR PROCEDURE BUT TO WORSENING PRE-EXISTING CONDITION. IT WAS ALSO REPORTED AS TARGET LESION RELATED. THE PATIENT OUTCOME IS REPORTED AS "RESOLVED/RECOVERED". ON REVIEW OF THE EVENT BY VERYAN IT WAS DETERMINED TO BE POSSIBLY RELATED TO THE DEVICE AS IT LED TO A TARGET LESION REVASCULARISATION AND IT INVOLVED PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY / STANDARD BALLOON ANGIOPLASTY AND LASER ATHERECTOMY. THIS INTERVENTION TOOK PLACE ON (B)(6) 2022. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Restenosis

  MAUDE report 14987635 ↗
• InjuryJul 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 6.0 X 100MM ) TO TREAT A RESTENOTIC LESION OF THE SFA MIDDLE THIRD ARTERY IN THE LEFT LEG. A RETROGRADE 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 (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 OR PROCEDURE BUT TO WORSENING PRE-EXISTING CONDITION. IT WAS ALSO REPORTED AS TARGET LESION RELATED. THE PATIENT OUTCOME IS REPORTED AS "RESOLVED/RECOVERED". ON REVIEW OF THE EVENT BY VERYAN ON (B)(6) 2022, IT WAS DETERMINED TO BE POSSIBLY RELATED TO THE DEVICE AS IT LED TO A TARGET LESION REVASCULARISATION (TLR). THE INTERVENTION INCLUDED PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY / STANDARD BALLOON ANGIOPLASTY, DRUG COATED/DRUG ELUTING BALLOON, SHOCKWAVE AND LASER ATHERECTOMY WHICH TOOK PLACE ON (B)(6) 2022 . THE DEVICE REMAINS IMPLANTED.

  Patient problems: Restenosis

  MAUDE report 14884807 ↗
• MalfunctionJun 1, 2022Fracture; Stretched; Difficult or Delayed Activation; Difficult to Advance; Fracture; Stretched; Difficult or Delayed Activation; Difficult to Advance

  ON THE (B)(6) 2022 DURING AN IMPLANTATION OF A BIOMIMICS 3D DEVICE WHERE THE PHYSICIAN USED A PEDAL ACCESS OVER A 6/5 TERUMO GLIDESHEATH SLENDER OVER A MONGO WIRE, THE BIOMIMICS STENT ELONGATED. THE PHYSICIAN CONFIRMED THEY PIN AND PULLED AND THE MANAGER CONFIRMED THE PIN DID NOT MOVE. THE PATIENT MUST RETURN FOR ADDITIONAL FOLLOW-UP. THE PHYSICIAN BELIEVES THAT THE STENT ELONGATION IS RELATED TO THE DEVICE.

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

  MAUDE report 14564687 ↗