BioMimics 3D Vascular Stent System 142122-03Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 05391526850404), received between Feb 8, 2022 and Nov 15, 2024 — classified as 26 injuries, 1 malfunction.

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 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• InjuryNov 15, 2024Adverse 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 11-APR-22, THE PATIENT WAS IMPLANTED WITH ONE BIOMIMICS 3D (BM3D) STENT. A 7.0 X 60 MM STENT WAS USED TO TREAT A DENOVO LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) PROXIMAL THIRD IN THE RIGHT LEG. A RETROGRADE APPROACH WAS USED AND THE LESION WAS PREPARED USING PRE-DILATION WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) AND ATHERECTOMY. ON 23-APR-24, 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 REQUIRED PERCUTANEOUS INTERVENTION. IT WAS REPORTED AS TARGET LESION RELATED. AN IN-STENT STENOSIS OF THE RIGHT SFA STENT WAS IDENTIFIED, AS PER AN ARTERIAL DOPPLER THAT WAS PERFORMED BY THE SITE. THE EVENT WAS TREATED ON 09-SEP-24, WITH PTA/STANDARD BALLOON ANGIOPLASTY AND LASER/ATHERECTOMY OF THE SFA PROXIMAL THIRD TO SFA MIDDLE THIRD SEGMENT. IT WAS A TARGET LESION/VESSEL REVASCULARISATION (TLR/TVR). THE OUTCOME WAS REPORTED AS RESOLVED/RECOVERED. THE DEVICE REMAINS IMPLANTED. VERYAN'S DATE OF AWARENESS OF THIS EVENT WAS 31-MAY-24 AND FOLLOWING ADDITIONAL INFORMATION PROVIDED BY THE S

  Patient problems: Restenosis

  MAUDE report 20694407 ↗
• InjuryOct 1, 2024Adverse 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 7.0 X 60 MM STENT WAS USED TO TREAT A RESTENOTIC LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) PROXIMAL THIRD IN THE RIGHT LEG. A CONTRALATERAL APPROACH WAS USED AND THE LESION WAS PRE-DILATED WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) AND A MEDTRONIC DRUG COATED/ELUTING BALLOON (DCB/DEB). THE TREATED SEGMENT WAS POST-DILATED WITH PTA. ON THE (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 PATIENT COMPLAINED OF RIGHT LEG CLAUDICATION AND A DUPLEX ULTRASOUND (DUS) SUGGESTED SIGNIFICANT DISEASE IN THE PROXIMAL RIGHT SFA. THE PATIENT WAS TAKEN INTO THE CATH LAB FOR PERCUTANEOUS INTERVENTION AND THE PROCEDURE SHOWED THAT THERE WAS EDGE STENT RESTENOSIS OF THE PROXIMAL RIGHT SFA AT 70%. THE STENOSIS WAS TREATED WITH A LUTONIX DCB/DEB, AND THE RESULTS SHOWED LESS THAN 20% RES

  Patient problems: Pain; Restenosis

  MAUDE report 20343830 ↗
• InjuryAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT THE DATE OF ONSET WAS UPDATED TO (B)(6) 2024.

  Patient problems: Restenosis

  MAUDE report 20042409 ↗
• InjuryApr 18, 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) 7.0 X 60 MM STENT TO TREAT A DENOVO LESION IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA) MIDDLE THIRD TO SFA DISTAL THIRD ARTERY. A RETROGRADE APPROACH WAS USED AND THE LESION WAS PREPARED USING PRE-DILATION WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) AND ATHERECTOMY. THE TREATED SEGMENT WAS POST-DILATED WITH PTA AND A NON-BM3D BARE METAL STENT WAS PLACED POST-BM3D IMPLANTATION. ON (B)(6) 2023, 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. THE PATIENT WAS SEEN IN THE CLINIC ON (B)(6) 2023 COMPLAINING OF RUTHERFORD CLASS (RC) 3 SYMPTOMS BILATERALLY. ON (B)(6) 2023 BOTH ANKLE BRACHIAL INDEX (ABI) AND DUPLEX ULTRASOUND (DUS) WERE PERFORMED. RIGHT RESTING ABI = 0.67. DUS SHOWED "STENOSIS PROXIMAL TO STENT AND THROUGHOUT STENT AND IN POPLITEAL." A DIAGNOSTIC ANGIOGRAM WAS PERFORMED ON (B)(6) 2023 AND FOUND THE FOLLOWING: SEVERE STENOSIS IN THE PROXIMAL SFA STENT (A NON-BM3D BARE METAL STENT); SEVERE

  Patient problems: Pain; Restenosis

  MAUDE report 19132150 ↗
• InjuryJan 16, 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 RIGHT LEG, A 7.0 X 60 MM STENT WHICH WAS USED TO TREAT A DENOVO LESION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) PROXIMAL 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 26-JUN-23. 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 TARGET LESION-RELATED AND REQUIRED A PERCUTANEOUS INTERVENTION. DIAGNOSTIC ANGIOGRAPHY WAS PERFORMED ON THE RIGHT LOWER EXTREMITY (RLE) BUT NO INTERVENTION WAS PERFORMED INITIALLY, SECONDARY TO AN UNSCHEDULED FOLLOW-UP AND ULTRASOUND ON (B)(6) 2022, A FOCAL RIGHT DISTAL SFA OCCLUSION WITHOUT ANY OTHER EVIDENCE OF FLOW-LIMITING DISEASE, AND MONOPHASIC HEAVILY CALCIFIED DORSAL METATARSAL WERE IDENTIFIED. THE INTERVENTION WAS PERFORMED ON (B)(6) 2023 AND WAS REPORTED AS A TARGET VE

  Patient problems: Restenosis

  MAUDE report 18516305 ↗
• InjurySep 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS RELATED TO MDR REPORT 3011632150-2023-00110. 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 LEFT LEG, A 6.0 X 100 MM STENT WHICH WAS USED TO TREAT A RESTENOTIC LESION OF THE COMMON FEMORAL ARTERY TO SUPERFICIAL FEMORAL ARTERY (SFA) PROXIMAL THIRD. A RETROGRADE APPROACH WAS USED AND THE LESION WAS PREPARED USING PRE-DILATION WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON AND ATHERECTOMY. THE TREATED SEGMENT WAS POST-DILATED WITH PTA. ON (B)(6) 2022 A SECOND BM3D STENT, A 7.0 X 60MM STENT WAS IMPLANTED TO TREAT A RESTENOSIS IN THE SFA PROXIMAL THIRD IN THE LEFT LEG (MDR REPORT NUMBER 3011632150-2022-00026). A RETROGRADE APPROACH WAS USED AND THE LESION WAS PREPARED USING PRE-DILATION WITH PTA AND ATHERECTOMY AND POST-DILATED WITH PTA. THE SITE IDENTIFIED A RESTENOSIS OF TREATED SEGMENT (TARGET LESION) ON (B)(6) 2023. THE PATIENT UNDERWENT A ROUTINE DUPLEX ULTRASOUND (DUS) ON (B)(6) 2023 WHICH SHOWED A FLOW LIMITING STENOSIS OF THE PROXIMAL LEFT SFA. A CLINIC VISIT ON (B)(6) 2023 NOTED THAT THE PATIENT WAS EXPERIENCING WORSENING CLAUDICATION

  Patient problems: Pain; Reduced Blood Flow; Restenosis; Skin Infection; Swelling/ Edema; Tissue Breakdown

  MAUDE report 17669034 ↗
• InjuryAug 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS RELATED TO MDR NUMBER 3011632150-2023-00099. 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 7.0 X 60 MM STENT (THE SUBJECT OF THIS REPORT) WHICH WAS USED TO TREAT A DENOVO LESION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) PROXIMAL THIRD TO MIDDLE THIRD SEGMENT AND A 6.0 X 150 MM STENT WHICH WAS USED TO TREAT A DENOVO LESION OF THE SFA DISTAL THIRD TO PROXIMAL POPLITEAL SEGMENT. A CONTRALATERAL APPROACH WAS USED AND THE LESIONS WERE 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 HAD SEVERE CLAUDICATION WHICH WAS MORE PRONOUNCED IN THE RIGHT LEG THAN THE LEFT LEG. A DUPLEX ULTRASOUND (DUS) ON THE (B)(6) 2023 SHOWED A RIGHT LEG EXTREMITY (RLE) IN-STENT SFA OCCLUSION DOWN TO THE TIBIOPERO

  Patient problems: Pain; Restenosis

  MAUDE report 17451074 ↗
• InjuryAug 2, 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 LEFT LEG, A 7.0 X 60 MM STENT WHICH WAS USED TO TREAT A DENOVO LESION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) MIDDLE THIRD TO DISTAL THIRD SEGMENT. 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. THE SITE IDENTIFIED A RESTENOSIS OF TREATED VESSEL (TARGET VESSEL) 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 HAD LEFT LEG EXTREMITY (LLE) PAIN. DUPLEX ULTRASOUND (DUS) ON (B)(6) 2023 SHOWED RESTENOSIS OF THE PROXIMAL STENT. A LEFT LEG ANGIOGRAM ON (B)(6) 2023 WAS PERFORMED FOR AN IN-STENT RESTENOSIS (ISR). THIS INCLUDED LASER AND PLAIN OLD BALLOON ANGIOPLASTY (POBA). THE OUTCOME WAS REPORTED AS CONTINUING. THE DEVICE REMAINS IMPLANTED. THE EVENT WAS REVIEWED ON 06-JUL-23 BY VERYAN AND CONSIDERED POSSIBLY RELATED TO THE DEVICE.

  Patient problems: Pain; Restenosis

  MAUDE report 17446657 ↗
• InjuryJul 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS RELATED TO MDR NUMBER 3011632150-2023-00091. 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 LEFT LEG, A 7.0 X 125 MM STENT WHICH WAS USED TO TREAT A DENOVO LESION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) MIDDLE THIRD TO PROXIMAL POPLITEAL SEGMENT AND A 7.0 X 60 MM STENT (THE SUBJECT OF THIS REPORT) WHICH WAS USED TO TREAT A DENOVO LESION OF THE SFA PROXIMAL THIRD SEGMENT. A CONTRALATERAL APPROACH WAS USED AND THE LESION WAS PREPARED USING PRE-DILATION WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON. THE TREATED SEGMENT WAS POST-DILATED WITH PTA. THE SITE IDENTIFIED A RESTENOSIS OF TREATED SEGMENT (TARGET LESION) ON (B)(6)2022. IT WAS REPORTED AS POSSIBLY RELATED TO THE DEVICE AND NOT RELATED TO THE PROCEDURE. IT WAS ALSO REPORTED AS TARGET LESION RELATED. THE PATIENT HAD A COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) OF THE ABDOMINAL AORTA AND BILATERAL LOWER EXTREMITY RUNOFF ON (B)(6)2022 WHICH SHOWED THAT THE LEFT LOWER EXTREMITY (LLE) SFA WAS OCCLUDED AT THE OSTIUM INCLUDING OCCLUSION OF THE TWO BM3D STENTS. THE PATIENT RETURNED FOR AN OF

  Patient problems: Restenosis

  MAUDE report 17406571 ↗
• InjuryJul 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS RELATED TO MDR NUMBER 3011632150-2023-00125. 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 (THE SUBJECT OF THIS REPORT) 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 PLACED IN THE LEFT SFA DISTAL THIRD TO PROXIMAL POPLITEAL SEGMENT ON (B)(6) 2022 FOR A RESTENOSIS. 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 INTERVENTION WAS PERFORMED ON (B)(6) 2023. THIS INVOLVED DRUG COATED BALLOON/DRUG ELUTING BALLOON (DCB/DEB), PTA/STANDARD BALLOON ANGIOPLASTY AND LASER ATH

  Patient problems: Restenosis

  MAUDE report 17343731 ↗
• InjuryJul 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS TREATED AS PART OF THE MIMICS 3D USA POST-MARKET OBSERVATIONAL STUDY. ON THE (B)(6)2021, THE PATIENT WAS IMPLANTED WITH ONE BIOMIMICS 3D (BM3D) STENT, A 7.0 X 60 MM STENT WHICH WAS USED TO TREAT A DENOVO LESION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) OSTIAL TO 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 POST-DILATED WITH PTA. THE SITE IDENTIFIED A RESTENOSIS OF TREATED SEGMENT (TARGET LESION) ON (B)(6)2023. IT WAS REPORTED AS NOT RELATED TO THE DEVICE OR PROCEDURE BUT DUE TO A WORSENING PRE-EXISTING CONDITION. IT WAS ALSO REPORTED AS TARGET LESION RELATED. PATIENT COMPLAINED OF LEFT LEG EXTREMITY (LLE) PAIN AND HEAVINESS. DUPLEX ULTRASOUND (DUS) SHOWED LEFT SFA IN-STENT RESTENOSIS (ISR). ANGIOGRAM OF THE LLE ON (B)(6)2023 SHOWED LEFT SFA AND POPLITEAL (POP) SEVERE ISR AND SHORT SEGMENTS OF OCCLUSIONS WITHIN THE STENTS. THE INTERVENTION INVOLVED A BARE METAL STENT PLACEMENT (NON BM3D), PTA/STANDARD BALLOON ANGIOPLASTY AND LASER/ATHERECTOMY OF THE SFA PROXIMAL THIRD TO DISTAL POP SEGMENT. THE INTERVENTIO

  Patient problems: Discomfort; Pain; Restenosis

  MAUDE report 17257936 ↗
• InjuryJun 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS RELATED TO MDR NUMBER 3011632150-2023-00072. THE PATIENT WAS TREATED AS PART OF THE MIMICS 3D USA POST-MARKET OBSERVATIONAL STUDY. ON THE 17-MAY-22, THE PATIENT WAS IMPLANTED WITH ONE BIOMIMICS 3D (BM3D) STENT, A 7.0 X 60MM STENT (THE SUBJECT OF THIS REPORT) WHICH WAS USED TO TREAT A DE NOVO LESION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) PROXIMAL THIRD IN THE RIGHT LEG. A RETROGRADE APPROACH WAS USED AND THE LESION WAS PREPARED USING PRE-DILATION WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON AND ATHERECTOMY. THE TREATED SEGMENT WAS ALSO POST-DILATED WITH PTA. ANOTHER BM3D 7.0 X 150MM STENT WAS IMPLANTED ON 21-OCT-22 IN THE SFA PROXIMAL THIRD TO SFA MIDDLE THIRD FOR A RESTENOSIS OF TREATED VESSEL (TARGET VESSEL). THE SITE IDENTIFIED A RESTENOSIS OF TREATED SEGMENT (TARGET LESION) ON 02-MAY-23. THE PATIENT'S IMAGING WHICH INCLUDED DIAGNOSTIC INTRAVASCULAR ULTRASOUND (IVUS) NON-INTERVENTIONAL ASSESSMENT OF THE RIGHT SFA SHOWED THE FOLLOWING FINDINGS: THERE WAS A STENT EXTENDING FROM THE OSTIUM OF THE SFA DOWN TO THE PROXIMAL/MID SFA SEGMENT WHICH WAS COMPLETELY OCCLUDED. THE MID TO DISTAL RIGHT SFA HAD A STENT THAT RECANALISED VIA COLLATERALS FROM THE PROFUNDA FEMOR

  Patient problems: Obstruction/Occlusion; Restenosis

  MAUDE report 17169886 ↗
• MalfunctionJun 13, 2023Fracture; Material Deformation; Fracture; Material Deformation

  ON (B)(6) 2023, A PHYSICIAN INTENDED TO TREAT THE RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) OF A PATIENT USING 7 X 60MM BIOMIMICS 3D (BM3D) DEVICE. THE PATIENT'S VESSEL ANATOMY WAS DESCRIBED AS HAVING MODERATE CALCIFICATION AND A 99% STENOTIC LESION AT THE TARGET SITE. A CONTRALATERAL APPROACH WAS TAKEN, USING A 65CM 6 FR TERUMO DESTINATION GUIDEWIRE AND A 0.014" ASAHI GRANDSLAM GUIDEWIRE. THE TARGET VESSEL WAS PREPARED WITH BALLOON ANGIOPLASTY VIA A 7 X 60 MM SHOCKWAVE DEVICE, AND DRUG COATED BALLOON (DCB) VIA 7 X 60 MM AND 7 X 40 MM LUTONIX DEVICES. THE DEVICE WAS FLUSHED AS PER THE INSTRUCTION FOR USE (IFU), AND THEN INTRODUCED INTO THE PATIENT AND ADVANCED TO THE TARGET SITE. THE PHYSICIAN REMOVED ANY SLACK FROM THE SYSTEM AND DEPLOYMENT OF THE STENT WAS INITIATED WHILE HOLDING THE PROXIMAL PIN LUER IN A FIXED POSITION. THERE WERE NO ISSUES WHILE THE STENT WAS BEING DEPLOYED. THE PHYSICIAN ELECTED TO POST-DILATE THE STENT, HOWEVER THERE WAS DIFFICULTY IN CROSSING THE 7 X 60 MM COMPLAINT STENT. THE PHYSICIAN SWITCHED GUIDEWIRES FROM A 0.014" GUIDEWIRE TO A 0.035" J-SHAPED GUIDEWIRE. THE STENT WAS CROSSED WITH A 7 X 60MM BARD ULTRAVERSE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17115801 ↗
• InjuryMay 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS TREATED AS PART OF THE MIMICS 3D USA POST-MARKET OBSERVATIONAL STUDY. ON THE (B)(6) 2022, THE PATIENT WAS IMPLANTED WITH ONE BIOMIMICS 3D (BM3D) STENT, A 7.0 X 60 MM STENT WHICH WAS USED TO TREAT A DENOVO LESION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) PROXIMAL THIRD IN THE RIGHT LEG. A RETROGRADE APPROACH WAS USED AND THE LESION WAS PREPARED USING PRE-DILATION WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON AND ATHERECTOMY. THE TREATED SEGMENT WAS ALSO POST-DILATED WITH PTA. THE SITE REPORTED THAT ON (B)(6) 2022, A RESTENOSIS OF TREATED SEGMENT (TARGET LESION) WAS IDENTIFIED. THE RELATIONSHIP TO THE DEVICE AND PROCEDURE WAS REPORTED AS NOT ASSESSABLE/UNKNOWN AND DUE TO A WORSENING PRE-EXISTING CONDITION. IT WAS REPORTED AS TARGET LESION RELATED AND REQUIRED PERCUTANEOUS INTERVENTION. THE PATIENT PRESENTED WITH REST PAIN IN THE RIGHT FOOT AND RUTHERFORD CLASS IV DISEASE. AN ARTERIAL DUPLEX ULTRASOUND REVEALED RECURRENT RIGHT SFA OCCLUSION AND FLOW-LIMITING DISEASE IN THE RIGHT POSTERIOR TIBIAL ARTERY. THE PATIENT HAD A KNOWN RIGHT ANTERIOR TIBIAL ARTERY OCCLUSION. DUE TO THE REST PAIN, THE PATIENT WAS SCHEDULED FOR URGENT RIGHT LOWER EXTREMITY ANGIOGRAPHY AN

  Patient problems: Pain; Restenosis

  MAUDE report 16916609 ↗
• InjuryMay 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS TREATED AS PART OF THE MIMICS 3D USA POST-MARKET OBSERVATIONAL STUDY. ON THE (B)(6) 2022, THE PATIENT WAS IMPLANTED WITH ONE BIOMIMICS 3D (BM3D) STENT, A 7.0 X 60 MM STENT WHICH WAS USED TO TREAT A DENOVO LESION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) DISTAL THIRD TO PROXIMAL POPLITEAL IN THE LEFT LEG. A CONTRALATERAL APPROACH WAS USED AND THE LESION WAS PREPARED USING ATHERECTOMY. THE TREATED SEGMENT WAS ALSO POST DILATED WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON. 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 PRE-EXISTING CONDITION. IT WAS REPORTED AS TARGET LESION RELATED AND REQUIRED PERCUTANEOUS INTERVENTION. THE PATIENT HAD CLAUDICATION AND ELEVATED VELOCITIES WITHIN THE SFA STENT SHOWN ON DUPLEX ULTRASOUND (DUS) ON (B)(6) 2022. A LEFT LOWER EXTREMITY (LLE) ANGIOGRAM AND INTERVENTION THAT INVOLVED LASER ATHERECTOMY AND PTA/STANDARD BALLOON ANGIOPLASTY OF THE PROXIMAL THIRD OF THE SFA TO THE TIBIAL PERONEAL TRUNK (TPT) ON THE (B)(6) 2022. IT WAS REPORTED AS A TARGET LESION REVASCULARISATION (

  Patient problems: Pain; Restenosis

  MAUDE report 16916531 ↗
• 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 7.0 X 60 MM STENT WHICH WAS USED TO TREAT A RESTENOTIC LESION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) PROXIMAL THIRD SEGMENT 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. THE SITE REPORTED THAT ON (B)(6) 2021, AN EARLY OCCLUSION (7 - 30 DAYS TREATED VESSEL) WAS IDENTIFIED. DUPLEX ULTRASOUND (DUS) WAS PERFORMED (B)(6) 2021 AND INDICATED AN OCCLUSION IN THE TARGET LIMB SFA. PRIOR TO RECEIVING TREATMENT FOR THIS EVENT, THE PATIENT HAD THROMBECTOMY AND THROMBOLYSIS OF THE COMMON PROXIMAL ILIAC TO COMMON FEMORAL ON (B)(6) 2022 AND COVERED STENT PLACEMENT AND PTA ON (B)(6) 2022. CATHETER-BASED PENUMBRA THROMBOENDARTERECTOMY OF THE RIGHT EXTERNAL ILIAC, RIGHT COMMON FEMORAL, AND PROFUNDA FEMORAL ARTERY, AND RIGHT EXTERNAL ILIAC PTA AND STENTING WERE PERFORMED (B)(6) 2022. THE OCCLUSION WAS REPORTED AS NOT RELATED TO THE DEVICE AND NOT RELATED TO

  Patient problems: Obstruction/Occlusion

  MAUDE report 16622846 ↗
• 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 7.0 X 60MM BIOMIMICS 3D (BM3D) STENT TO TREAT A DENOVO LESION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) MIDDLE 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. 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 LEG EXTREMITY (LLE) CLAUDICATION. THE LEFT SFA TO THE POPLITEAL SEGMENT WAS TREATED WITH ANGIOPLASTY AND LASER ATHERECTOMY. THE PATIENT OUTCOME WAS REPORTED AS RESOLVED/RECOVERED AND THE DEVICE REMAINS IMPLANTED. THE EVENT WAS REVIEWED BY VERYAN ON (B)(6) 2023 AND CONSIDERED POSSIBLY RELATED TO THE DEVICE. ADDITIONAL INFORMATION WAS PROVIDED BY THE SITE ON (B)(6) 2024 WHERE THE DATE OF ONSET AND THE DISTAL S

  Patient problems: Pain; Restenosis

  MAUDE report 16404316 ↗
• 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 7.0 X 60MM BIOMIMICS 3D (BM3D) STENT. THIS WAS USED TO TREAT A DE NOVO LESION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) OSTIAL TO SFA DISTAL THIRD IN THE LEFT LEG. A CONTRALATERAL APPROACH WAS USED AND THE LESION WAS PREPARED USING PERCUTANEOUS TRANSLUMINAL/STANDARD BALLOON ANGIOPLASTY (PTA) AND ATHERECTOMY. THE TREATED SEGMENT WAS ALSO POST-DILATED WITH PTA. IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT HAD A LEFT LEG LOWER EXTREMITY (LLE) ANGIOGRAM AND INTRAVASCULAR ULTRASOUND (IVUS), FOR A RESTENOSIS OF THE TREATED SEGMENT (TARGET LESION). ON (B)(6) 2021, THE PATIENT HAD A LASER ATHERECTOMY AND PTA OF THE SFA OSTIAL TO SFA PROXIMAL THIRD. 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

  Patient problems: Pain; Restenosis

  MAUDE report 15932889 ↗
• 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 7.0 X 60MM BIOMIMICS 3D (BM3D) STENT. THIS WAS USED TO TREAT A DE NOVO LESION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) OSTIAL TO SFA DISTAL 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 LASER ATHERECTOMY ON THE SFA PROXIMAL THIRD, FOR AN IN-STENT RESTENOSIS OF THE TARGET LESION AND ANGIOPLASTY AND STENTING OF THE NATIVE MIDDLE SFA AND ANGIOPLASTY OF THE COMMON FEMORAL ARTERY. THE ANGIOPLASTY AND STENTING OF THE NATIVE MIDDLE SFA AND COMMON FEMORAL ARTERY WERE NOT RELATED TO THE TARGET LESION. 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 WAS DUE TO A WORSENING OF THE PATIENT'S PRE-EXISTING CONDITION AND TARGET LESION RELA

  Patient problems: Pain; Restenosis

  MAUDE report 15932799 ↗
• InjuryDec 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 THE (B)(6) 2021, THE PATIENT WAS IMPLANTED WITH ONE 7.0 X 60MM BIOMIMICS 3D (BM3D) STENT. THIS WAS USED TO TREAT A DE NOVO LESION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) OSTIAL TO SFA DISTAL 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 RETURNED FOR A DUPLEX ULTRASOUND (DUS) WHICH REVEALED AN IN-STENT RESTENOSIS OF THE TREATED AREA AND WORSENING OF THIS RESTENOSIS WAS IDENTIFIED ON (B)(6) 2022 ON A SUBSEQUENT DUS. ON (B)(6) 2022, THE PATIENT HAD A PTA / STANDARD BALLOON ANGIOPLASTY AND LASER ATHERECTOMY OF THE COMMON FEMORAL ARTERY TO THE PROXIMAL POPLITEAL ARTERY. 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-EXISITING CONDITION AND

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

  MAUDE report 15925160 ↗
• InjuryNov 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS RELATED TO MDR NUMBER 3011632150-2022-00100. THE PATIENT WAS ENROLLED IN THE MIMICS 3D USA REGISTRY STUDY ON (B)(6) 2021. TWO BIOMIMICS 3D (BM3D) STENTS WERE IMPLANTED TO TREAT RESTENOTIC LESIONS IN THE LEFT LEG. ONE STENT (A 7X 60MM STENT) WAS PLACED IN THE SFA MIDDLE THIRD AND THE OTHER (A 7.0 X 100MM STENT) WAS PLACED IN THE SFA DISTAL THIRD TO PROXIMAL POPLITEAL ARTERY. A CONTRALATERAL APPROACH WAS USED AND THE LESIONS WERE PREPARED USING ATHERECTOMY AND PRE-DILATED USING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON ANGIOPLASTY. THE LESIONS WERE ALSO POST-DILATED USING PTA. THE CLINIC IDENTIFIED A RESTENOSIS OF TREATED SEGMENT (TARGET LESION) EVENT ON (B)(6) 2022 IN THIS PATIENT. IT WAS REPORTED AS "NOT RELATED" TO THE DEVICE OR PROCEDURE BUT DUE TO A WORSENING PRE-EXISTING CONDITION. THE EVENT IS REPORTED AS TARGET LESION RELATED AND REQUIRED PERCUTANEOUS INTERVENTION TO RESOLVE. THE INTERVENTION TOOK PLACE ON THE (B)(6) 2022 AND INCLUDED NON BM3D BARE METAL STENT PLACEMENT, DRUG COATED BALLOON/DRUG ELUTING BALLOON ANGIOPLASTY AND PTA ON THE PROXIMAL THIRD SFA TO DISTAL THIRD SFA SEGMENT. THE INTERVENTION IS REPORTED AS A TARGET LESION REVASCULARISATION (TLR). T

  Patient problems: Restenosis

  MAUDE report 15796127 ↗
• InjurySep 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS RELATES TO MDR NUMBER 3011632150-2022-00086. THE PATIENT WAS TREATED AS PART OF THE MIMICS 3D USA POST-MARKET OBSERVATIONAL STUDY ON (B)(6) 2021. THE SUBJECT WAS IMPLANTED WITH TWO BIOMIMICS 3D (BM3D) STENTS (ONE 7.0 X 60MM STENT (THIS REPORT) IN THE SFA PROXIMAL THIRD AND ONE 7.0 X 80MM BM3D STENT IN THE SFA DISTAL THIRD) TO TREAT DENOVO LESIONS IN THE RIGHT LEG. A RETROGRADE APPROACH WAS USED AND THE TARGET LESION WAS PREPARED BY PRE-DILATION OF THE TARGET LESION WITH A STANDARD BALLOON ANGIOPLASTY AND ATHERECTOMY. POST-DILATION WAS CONDUCTED WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). ON THE (B)(6) 2022, AN EVENT OF RESTENOSIS OF TREATED SEGMENT (TARGET LESION) WAS REPORTED FROM THE SITE. IT WAS REPORTED AS "NOT RELATED" TO THE DEVICE AND "NOT RELATED" TO THE PROCEDURE BUT DUE TO A WORSENING PRE-EXISTING CONDITION. IT WAS ALSO REPORTED AS TARGET LESION RELATED. IT LED TO A PERCUTANEOUS INTERVENTION AND IT INVOLVED A TARGET LESION REVASCULARISATION ON (B)(6) 2022 WITH BARE METAL STENT PLACEMENT, CUTTING BALLOON , LASER ATHERECTOMY AND THROMBECTOMY. THE DEVICES REMAIN IMPLANTED. THE PATIENT OUTCOME IS REPORTED AS "RESOLVED/RECOVERED". THE EVENT WAS REVIEWED ON 22-AUG-22

  Patient problems: Thrombosis/Thrombus

  MAUDE report 15455701 ↗
• InjuryAug 10, 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 ( 7.0 X 60MM STENT) TO TREAT A DENOVO LESION OF THE SFA MIDDLE THIRD IN THE RIGHT LEG. A CONTRALATERAL APPROACH WAS USED AND PRE- AND POST DILATATION WAS CONDUCTED WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). A THROMBECTOMY WAS CONDUCTED POST BM3D STENT PLACEMENT. ON THE (B)(6) 2022, AN EVENT OF OCCLUSION WAS REPORTED FROM THE SITE. IT WAS REPORTED AS "NOT RELATED" TO THE DEVICE AND "POSSIBLY RELATED" TO THE PROCEDURE BUT DUE TO WORSENING PRE-EXISTING CONDITION. THE RELATIONSHIP TO THE PROCEDURE IS BEING CLARIFIED AS THE IMPLANTATION WAS ON (B)(6) 2021 AND THE EVENT WAS IDENTIFIED ON (B)(6) 2022. 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 PTA BALLOON ANGIOPLASTY AND DRUG ELUTING BALLOON, DRUG ELUTING STENT PLACEMENT AND LASER ATHERECTOMY AND GRAFT BYPASS OF THE OCCLUSION. THE DEVICE REMAINS IMPLANTED. THE PATIENT OUTCOME IS REPORTED AS "RESOLVED/RECOVERED". THIS WAS REVIEWED BY VERYAN ON (B)(6) 2022 AND CONS

  Patient problems: Obstruction/Occlusion

  MAUDE report 15196968 ↗
• InjuryJul 26, 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 ( 7.0 X 60MM STENT) TO TREAT A DENOVO LESION OF THE SFA OSTIAL TO SFA PROXIMAL THIRD ARTERY IN THE LEFT LEG. A CONTRALATERAL APPROACH WAS USED AND PRE-DILATATION AND POST-DILATATION OF THE TARGET LESION WAS CONDUCTED WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA), AND ATHERECTOMY. ON THE (B)(6) 2022, AN EVENT OF RESTENOSIS OF TREATED SEGMENT TARGET LESION) WAS REPORTED FROM THE SITE. IT WAS REPORTED AS "NOT RELATED" TO THE DEVICE AND "NOT RELATED" TO THE PROCEDURE BUT DUE TO WORSENING PRE-EXISTING CONDITION. IT WAS ALSO REPORTED AS TARGET LESION RELATED. THE PATIENT OUTCOME IS REPORTED AS "RESOLVED/RECOVERED". IT LED TO A PERCUTANEOUS INTERVENTION ON (B)(6) 2022 AND IT INVOLVED BALLOON ANGIOPLASTY AND LASER ATHERECTOMY AND TWO STENT PLACEMENTS. THE DEVICE REMAINS IMPLANTED. THIS WAS REVIEWED BY VERYAN ON (B)(6) 2022 AND CONSIDERED TO BE POSSIBLY RELATED TO THE DEVICE AS IT LED TO A TARGET LESION REVASCULARISATION.

  Patient problems: Pain; Restenosis

  MAUDE report 15108666 ↗
• InjuryJun 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS MDR IS RELATED TO 3011632150-2022-00032. THE PATIENT WAS TREATED AS PART OF THE MIMICS 3D USA POST-MARKET OBSERVATIONAL STUDY ON (B)(6) 2021. THE SUBJECT WAS IMPLANTED WITH TWO BIOMIMICS-3D STENTS (A 7.0 X 60MM AND A 7.0 X 80MM) TO TREAT A DENOVO LESION OF THE SFA MIDDLE THIRD TO SFA DISTAL THIRD OF THE LEFT LEG. A CONTRALATERAL APPROACH WAS USED AND PRE-DILATATION AND POST-DILATATION OF THE TARGET LESION WAS CONDUCTED WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. ATHERECTOMY WAS ALSO PERFORMED PRE-STENT PLACEMENT. ON AN UNKNOWN DATE IN JUNE 2021, AN EVENT OF THROMBOSIS OF TREATED SEGMENT WAS IDENTIFIED AND REPORTED TO VERYAN ON (B)(6) 2022. IT WAS REPORTED AS "NOT RELATED" TO THE DEVICE OR PROCEDURE BUT TO A WORSENING OF THE PRE-EXISTING CONDITION. THE EVENT REQUIRED A TARGET LESION REVASCULARISATION (TLR) THAT INVOLVED PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY / STANDARD BALLOON ANGIOPLASTY AND THROMBECTOMY. THE EVENT IS REPORTED AS SERIOUS. THE PATIENT OUTCOME IS DESCRIBED AS RESOLVED/RECOVERED. THE DEVICES REMAIN IMPLANTED. ON REVIEW OF THE EVENT BY VERYAN, IT WAS DETERMINED TO BE POSSIBLY RELATED TO THE DEVICE DUE TO THE TARGET LESION RELATIONSHIP.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 14563025 ↗