BioMimics 3D Vascular Stent System 142122-14Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 05391526850480), received between Jan 10, 2022 and Jul 2, 2025 — classified as 22 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (3 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 26 reports, in the reporter's own words as published by the FDA.

• InjuryJul 2, 2025Adverse 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, THE PATIENT (FEMALE) WAS IMPLANTED WITH ONE BIOMIMICS 3D STENT (BM3D) TO TREAT A DE NOVO LESION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) MIDDLE THIRD IN THE RIGHT LEG ON (B)(6) 2022. A RETROGRADE APPROACH WAS USED AND THE LESION WAS PREPARED USING PRE-DILATION WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) AND ATHERECTOMY. THE PATIENT'S MEDICAL HISTORY INCLUDED HYPERTENSION, HYPERCHOLESTEROLEMIA/DYSLIPIDEMIA, FORMER SMOKER AND RENAL INSUFFICIENCY. THE PATIENT WAS 72 YEARS AT THE TIME OF THE EVENTS. ON (B)(6) 2025 THE SITE IDENTIFIED AN OCCLUSION IN THE TARGET VESSEL REQUIRING INTERVENTION, IT WAS REPORTED AS SERIOUS AND POSSIBLY RELATED TO THE DEVICE AND NOT RELATED TO THE PROCEDURE. IT WAS TARGET LESION-RELATED AND REQUIRED PERCUTANEOUS INTERVENTION. THE INTERVENTION WAS PERFORMED ON (B)(6) 2025 AND INVOLVED A BARE METAL STENT PLACEMENT, A DRUG-COATED/DRUG ELUTING BALLOON, AND LASER/ATHERECTOMY OF THE SFA PROXIMAL THIRD TO SFA MIDDLE THIRD. IT WAS REPORTED AS A TARGET LESION AND TARGET VESSEL REVASCULARISATION (TLR/TVR). ON (B)(6) 2025, THE SITE IDENTIFIED A DISSECTION (GRADE C OR GREATER) IN TA

  Patient problems: Obstruction/Occlusion; Restenosis

  MAUDE report 22381721 ↗
• InjuryFeb 4, 2025Adverse 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 REGISTRY STUDY. ON (B)(6) 2021, THE PATIENT WAS IMPLANTED WITH ONE 6.0 X 125MM BIOMIMICS 3D (BM3D) STENT TO TREAT A DENOVO LESION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) PROXIMAL THIRD TO MIDDLE THIRD IN THE LEFT LEG. A CONTRALATERAL APPROACH WAS USED AND THE LESION WAS PREPARED USING PRE-DILATION WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON AND ATHERECTOMY. THE TREATED SEGMENT WAS POST-DILATED WITH PTA. ON (B)(6) 2024, A RESTENOSIS OF THE TREATED SEGMENT (TARGET LESION) WAS IDENTIFIED BY THE SITE. THE RELATIONSHIP TO THE STUDY DEVICE AND PROCEDURE WERE REPORTED BY THE SITE AS NOT RELATED. IT WAS REPORTED AS RELATED TO A WORSENING PRE-EXISTING CONDITION. IT WAS TARGET LESION-RELATED AND REQUIRED PERCUTANEOUS INTERVENTION. THE INTERVENTION WAS PERFORMED ON (B)(6) 2024 AND INVOLVED A NON-BM3D BARE METAL STENT, LASER/ ATHERECTOMY AND PTA/STANDARD BALLOON ANGIOPLASTY ON THE SFA PROXIMAL THIRD TO SFA DISTAL THIRD SEGMENT. IT WAS REPORTED AS A TARGET LESION/VESSEL REVASCULARISATION (TLR/TVR). THE SITE PROVIDED THE FOLLOWING COMMENTS THAT WERE REPORTED AS "PROXIMAL TO DISTAL SFA TREATED.". THE OUTCOME WAS

  Patient problems: Restenosis

  MAUDE report 21305396 ↗
• InjuryApr 17, 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) 2022, THE PATIENT WAS IMPLANTED WITH ONE BIOMIMICS 3D (BM3D) 6.0 X 125 MM STENT TO TREAT A DENOVO LESION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) MIDDLE THIRD TO THE PROXIMAL POPLITEAL SEGMENT. AN ANTEGRADE 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. ON 22-JUN-23, A RESTENOSIS OF THE TREATED SEGMENT (TARGET LESION) WAS IDENTIFIED AND 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 TARGET LESION-RELATED. THE PATIENT HAD THEIR 12-MONTH FOLLOW-UP VISIT ON 22-JUN-23 WHERE DUPLEX ULTRASOUND (DUS) WAS PERFORMED. THE PATIENT HAD AN UNSCHEDULED CLINIC VISIT ON 08-MAR-24 AND RUTHERFORD CLASS (RC) 5 SYMPTOMS WERE REPORTED: NON-HEALING ULCERATION AND REST PAIN. PREVIOUS IMAGING HAD DEMONSTRATED RE-OCCLUSION OF HIS RIGHT SFA AS WELL AS SINGLE VESSEL RUNOFF VIA THE POSTERIOR TIBIAL (PT) ARTERY. THERE WAS KNOWN ABSENT RIGHT TOE PRESSURES. THE PATIENT WAS LOST TO FOLLOW-UP IN DECEMBER,

  Patient problems: Impaired Healing; Pain; Restenosis; Ulcer

  MAUDE report 19127033 ↗
• InjuryApr 12, 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 125 MM STENT TO TREAT A DENOVO LESION IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) DISTAL THIRD TO PROXIMAL POPLITEAL ARTERY. A RETROGRADE APPROACH WAS USED AND THE LESION WAS PRE-DILATED WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) AND ATHERECTOMY. THE TREATED SEGMENT WAS POST-DILATED WITH PTA. ON (B)(6) 2022, A RESTENOSIS OF THE TREATED SEGMENT (TARGET LESION) WAS IDENTIFIED AND IT WAS REPORTED AS NOT RELATED TO THE DEVICE AND NOT RELATED TO THE PROCEDURE. IT WAS REPORTED AS BEING RELATED TO A WORSENING PRE-EXISTING CONDITION. THE PATIENT HAD SEVERE MULTI-LEVEL FLOW LIMITING DISEASE OF THE RIGHT FEMOROPOPLITEAL ARTERY. IT WAS TARGET LESION-RELATED. IT WAS REPORTED AS NOT SERIOUS BUT IT REQUIRED MEDICATION TO TREAT THE EVENT BUT NO PERCUTANEOUS INTERVENTION WAS REQUIRED. THE EVENT WAS ORIGINALLY REVIEWED BY VERYAN ON 22-MAY-23 WHERE IT WAS CONSIDERED POSSIBLY DEVICE RELATED. AS IT WAS REPORTED AS NOT SERIOUS AND HAD NOT REQUIRED ANY MEDICAL/SURGICAL INTERVENTION AT THE TIME IT WAS NOT REPORTABLE BUT FOLLOWING RECEIPT OF AD

  Patient problems: Restenosis

  MAUDE report 19094755 ↗
• InjuryApr 9, 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 125 MM STENT WHICH WAS USED TO TREAT A DENOVO LESION OF THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA) DISTAL THIRD TO PROXIMAL POPLITEAL. AN ANTEGRADE APPROACH WAS USED AND THE LESION WAS PREPARED USING ATHERECTOMY. ON (B)(6) 2023, THE SITE IDENTIFIED A RESTENOSIS OF TREATED SEGMENT (TARGET LESION). IT WAS REPORTED AS POSSIBLY RELATED TO THE DEVICE AND NOT RELATED TO THE PROCEDURE. IT WAS TARGET LESION-RELATED. IT REQUIRED A PERCUTANEOUS INTERVENTION ON (B)(6) 2023 AS THE SUBJECT HAD RUTHERFORD CLASS (RC) 4 SYMPTOMS. THE INTERVENTION WAS PERFORMED ON THE SFA DISTAL THIRD TO ANTERIOR TIBIAL DISTAL THIRD. IT INVOLVED PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA)/ STANDARD BALLOON ANGIOPLASTY, LASER ATHERECTOMY AND THROMBECTOMY. IT WAS REPORTED AS A TARGET LESION/VESSEL REVASCULARISATION (TLR/TVR). THE PATIENT OUTCOME WAS REPORTED AS RESOLVED/RECOVERED. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Ischemia; Pain; Restenosis

  MAUDE report 19069238 ↗
• InjuryMar 6, 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. THE PATIENT WAS IMPLANTED WITH ONE BIOMIMICS-3D STENT (A 6.0 X 125 MM) TO TREAT A DENOVO LESION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) MIDDLE THIRD TO SFA DISTAL THIRD OF THE RIGHT LEG. A CONTRALATERAL APPROACH WAS USED AND THE LESION WAS PREPARED USING PRE-DILATATION WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON AND ATHERECTOMY. THE TREATED SEGMENT WAS POST-DILATED WITH PTA. ON 16-DEC-22, AN EVENT OF OCCLUSION WAS REPORTED FROM THE SITE. IT WAS REPORTED AS "NOT RELATED" TO THE DEVICE OR PROCEDURE BUT WAS DUE TO A WORSENING PRE-EXISTING CONDITION. IT WAS REPORTED AS TARGET LESION RELATED. THE EVENT WAS REPORTED AS NOT SERIOUS. THE PATIENT OUTCOME IS DESCRIBED AS "CONTINUING". THE SUBJECT WAS SCHEDULED FOR ANGIOGRAPHY. ON (B)(6) 2023, THE EVENT WAS TREATED USING AN ANGIOGRAM WITH A 7 FRENCH (FR) CROSS-OVER SHEATH WHICH WAS PLACED AND THE PHYSICIAN TRIED MULTIPLE MANOEUVRES IN AN ATTEMPT TO CROSS THE FEM-POP OCCLUSIVE DISEASE WHICH WAS UNSUCCESSFUL. THE FINDINGS IDENTIFIED THAT THE RIGHT SFA ABOVE THE KNEE AND BELOW THE KNEE VESSELS ARE OCCLUDED. THERE WAS RECONSTRUCTION OF THE POSTERIOR

  Patient problems: Obstruction/Occlusion

  MAUDE report 18846397 ↗
• MalfunctionDec 21, 2023Insufficient Device Problem Information; Activation Failure; Insufficient Device Problem Information; Activation Failure

  ON (B)(6) 2023, A PHYSICIAN AT A US HEALTHCARE FACILITY WAS USING A 6.0 X 125 MM BIOMIMICS 3D DEVICE AND IT WAS REPORTED THAT IT PARTIALLY DEPLOYED. THERE WAS NO IMPACT TO THE PATIENT.

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

  MAUDE report 18375287 ↗
• MalfunctionDec 19, 2023Fracture; Material Separation; Stretched; Activation Failure; Physical Resistance/Sticking; Fracture; Material Separation; Stretched; Activation Failure; Physical Resistance/Sticking

  ON (B)(6) 2023, VERYAN WAS MADE AWARE OF DETAILS OF A PROCEDURE WHICH WAS PERFORMED ON (B)(6 )2023 INVOLVING A 6.0 X 125 MM BIOMIMICS 3D (BM3D) DEVICE. THE TARGET LESION WAS DESCRIBED AS A TIGHT STRICTURE THAT WAS SIGNIFICANTLY CALCIFIED. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY CROSS THE LESION AND PREPARE IT USING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BEFORE USING THE BM3D DEVICE. AFTER PREPARING AND FLUSHING THE BM3D DEVICE, THE PHYSICIAN WAS ABLE TO CROSS THE TARGET LESION WITHOUT DIFFICULTY. UPON DEPLOYMENT, THE PHYSICIAN NOTICED SIGNIFICANT RESISTANCE AND AFTER FULLY PINNING THE DELIVERY SYSTEM, THE STENT HAD NOT FULLY DEPLOYED. THE PHYSICIAN TRIED TO FREE THE STENT FROM THE DELIVERY SYSTEM BUT THE STENT BROKE OFF LEAVING ROUGHLY HALF OF THE STENT IN THE SUPERFICIAL FEMORAL ARTERY (SFA). THE PHYSICIAN THEN DEPLOYED A SECOND BM3D STENT WITHOUT DIFFICULTY OVER THE PORTION OF THE FIRST STENT TO SUCCESSFULLY CORRECT THE ISSUE. THERE WAS NO PATIENT IMPACT REPORTED.

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

  MAUDE report 18354605 ↗
• InjuryOct 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS RELATED TO MDR NUMBER 3011632150-2023-00010. 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 (THE STUDY DEVICE), A 6.0 X 150MM STENT WHICH WAS 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 10-MAR-22, AN EVENT OF OCCLUSION WAS REPORTED AND IT WAS TREATED WITH AN ADDITIONAL NON-STUDY 6.0 X 125 MM BM3D DEVICE (THE SUBJECT OF THIS REPORT) WHICH WAS PLACED IN THE SEGMENT BETWEEN THE SFA PROXIMAL THIRD AND SFA DISTAL THIRD. THE SITE REPORTED THAT ON (B)(6) 2022, A RESTENOSIS OF TREATED VESSEL (TARGET VESSEL) 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 NOT TARGET LESION-RELATED AND REQUIRED PERCUTANEOUS INTERVENTION. THE PATIENT HAD A RIGHT LEG EXTREMITY

  Patient problems: Pain; Restenosis

  MAUDE report 18001364 ↗
• InjuryOct 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS RELATED TO MDR REPORTS 3011632150-2023-00120 AND 3011632150-2023-00121. 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 THREE BIOMIMICS 3D (BM3D) STENTS IN THE RIGHT LEG, TWO 6.0 X 150 MM STENTS AND ONE 6.0 X 125 MM (THE SUBJECT OF THIS REPORT) STENT WERE USED TO TREAT A DENOVO LESION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) PROXIMAL THIRD TO DISTAL 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. THE SITE IDENTIFIED A RESTENOSIS OF TREATED SEGMENT (TARGET LESION) ON (B)(6) 2021. IT WAS REPORTED AS POSSIBLY RELATED TO THE STUDY DEVICE AND NOT RELATED TO THE STUDY PROCEDURE. IT WAS TARGET LESION RELATED. A POST-PROCEDURAL DUPLEX ULTRASOUND (DUS) ON (B)(6) 2021 SHOWED SEVERE ARTERIAL OCCLUSIVE DISEASE IN THE RIGHT COMMON FEMORAL ARTERY (CFA) AND MODERATE STENOSIS IN THE RIGHT SFA STENT. THERE WAS NO INTERVENTION CONDUCTED AT THE TIME. AT THE PATIENT'S 24-MONTH DUS ON (B)(6) 2022, ELEVATED VELOCITIES CONSISTENT WITH STENOSIS IN T

  Patient problems: Pain; Restenosis

  MAUDE report 17865102 ↗
• MalfunctionSep 6, 2023Fracture; Material Deformation; Fracture; Material Deformation

  ON (B)(6) 2023, A PHYSICIAN ATTEMPTED TO TREAT THE MID SUPERFICIAL FEMORAL ARTERY (SFA) OF A PATIENT'S LEFT LEG WITH A 6.0 X 125 MM BM3D DEVICE. THE PATIENT ANATOMY WAS NOTED AS HAVING AN OCCLUSION AND CALCIFICATION OF THE ENTIRE SFA. THE ACCESS TO THE TARGET SITE WAS ACHIEVED USING A TERUMO ACCESS SHEATH AND 0.018" COMMAND GUIDEWIRE. THE PHYSICIAN PREPARED THE TARGET LOCATION VIA BALLOON ANGIOPLASTY AND LASER ATHERECTOMY. THE BM3D DEVICE WAS FLUSHED IN ACCORDANCE WITH INSTRUCTION FOR USE (IFU). THE DEVICE WAS INTRODUCED INTO THE PATIENT. THE DEVICE WAS ADVANCED TO THE TARGET SITE. AT THIS POINT, SLACK WAS REMOVED FROM THE SYSTEM AND DEPLOYMENT OF THE STENT WAS INITIATED WHILE HOLDING THE PROXIMAL PIN LUER IN A FIXED POSITION. THE DEPLOYMENT ATTEMPT RESULTED IN THE SUCCESSFUL DEPLOYMENT OF THE BM3D STENT, AND FEEDBACK WAS PROVIDED THAT NO ISSUES WERE EXPERIENCED. IT WAS REPORTED THAT THERE WAS NO ELONGATION OF THE OUTER BRAID DURING THE DEPLOYMENT. FOLLOWING COMPLETION OF THE DEPLOYMENT OF THE BM3D STENT, THE PHYSICIAN REMOVED THE DELIVERY SYSTEM. THE PHYSICIAN THEN PERFORMED POST-DILATION WHERE THE BALLOON WAS INFLATED AT 11 ATMOSPHERES (ATM) FOR 30 SECONDS. THE BALLOON WAS THEN R

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

  MAUDE report 17688750 ↗
• InjuryAug 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS RELATED TO MDR NUMBER 3011632150-2023-00104. 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 150 MM STENT 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. ON (B)(6) 2022 AN ADDITIONAL 6.0 X 125 MM BM3D STENT (THE SUBJECT OF THIS REPORT) WAS PLACED IN THE SFA MIDDLE THIRD TO PROXIMAL POPLITEAL TO TREAT A RESTENOSIS. THE SITE REPORTED THAT ON (B)(6) 2023, A RESTENOSIS OF TREATED SEGMENT (TARGET LESION) WAS IDENTIFIED. THE DEVICE RELATIONSHIP WAS REPORTED AS POSSIBLY RELATED AND THE PROCEDURE RELATIONSHIP WAS REPORTED AS NOT RELATED. IT WAS REPORTED AS TARGET LESION-RELATED AND REQUIRED PERCUTANEOUS INTERVENTION. THE PATIENT PRESENTED FOR HER 12-MONTH FOLLOW-UP VISIT ON (B)(6) 2023. SHE HAD RECURRENT CLAUDICATION SYMPTOMS AND ISCHEMIC REST PAIN IN HER LEFT LEG. AN ULTRASOUND SHOWED SO

  Patient problems: Ischemia; Pain; Restenosis

  MAUDE report 17496589 ↗
• 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 6.0 X 125 MM STENT WHICH WAS USED TO TREAT A DENOVO LESION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) MIDDLE THIRD TO DISTAL THIRD IN THE LEFT LEG. AN ANTEGRADE APPROACH WAS USED AND THE LESION WAS PREPARED USING PRE-DILATION WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON AND ATHERECTOMY. THE TREATED SEGMENT WAS POST-DILATED WITH PTA. 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. DUPLEX ULTRASOUND (DUS) IDENTIFIED AN IN-STENT RESTENOSIS (ISR) IN THE LEFT SFA ON (B)(6) 2023. A LEFT LEG EXTREMITY (LLE) REVASCULARISATION WAS PERFORMED ON (B)(6) 2023 ON THE SFA MIDDLE THIRD TO DISTAL THIRD THAT INVOLVED LASER ATHERECTOMY AND PTA/STANDARD BALLOON ANGIOPLASTY. A SEVERE IN-STENT RESTENOSIS IN THE PROXIMAL ONE THIRD OF THE LEFT SFA WAS TREATED ALSO. THE INTERVENTION WAS REPORTED AS A TARGET LESION/VESSEL REVASCULARISATION (TLR/TV

  Patient problems: Restenosis

  MAUDE report 17254180 ↗
• InjuryJun 23, 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 125MM STENT WHICH WAS USED TO TREAT A DENOVO LESION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) MIDDLE 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 SITE IDENTIFIED A RESTENOSIS OF TREATED SEGMENT (TARGET LESION) ON (B)(6) 2023. IT WAS REPORTED AS DEFINITELY RELATED TO THE DEVICE AND NOT RELATED TO THE PROCEDURE. IT WAS TARGET LESION RELATED. THE PATIENT WAS SEEN IN CLINIC ON (B)(6) 2023 COMPLAINING OF LEG PAIN AT REST. CLINICAL SYMPTOMS INCLUDED NO PULSE IN RIGHT LEG, SKIN WAS COOL TO TOUCH, AND THERE WAS DISCOLORATION OF THE SHIN REPORTED AS ISCHEMIA WHICH WAS POSSIBLY RELATED TO THE DEVICE. A DIAGNOSTIC ANGIOGRAM WAS PERFORMED ON (B)(6) 2023 WHICH SHOWED THE RIGHT PROFUNDUS WAS TOTALLY OCCLUDED, THE MID-SFA STENT (TARGET) WAS 99% STENOSED, THE POPLITEAL ARTERY WAS 90% STENOSED, AND THE MID AND PROXIMAL SECTION OF THE POSTERIOR TIBIAL (PT) ARTERY WAS STENOSED. ON (B)(6) 2023, THE PAT

  Patient problems: Ischemia; Pain; Restenosis; Skin Discoloration

  MAUDE report 17191821 ↗
• InjuryMar 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS RELATED TO MDR REPORT NUMBER 3011632150-2023-00044. 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 150MM STENT WHICH WAS USED TO TREAT A RESTENOTIC LESION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) MIDDLE THIRD SEGMENT 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. THE PATIENT WAS ALSO IMPLANTED WITH A NON-STUDY 6.0 X 125 MM BM3D STENT (THE SUBJECT OF THIS REPORT) PLACED AS PART OF AN EARLIER RESTENOSIS TREATMENT ON (B)(6) 2022 IN THE SFA MIDDLE THIRD TO PROXIMAL POPLITEAL SEGMENT. THE SITE REPORTED THAT ON (B)(6) 2023 A RESTENOSIS OF TREATED SEGMENT (TARGET LESION) WAS IDENTIFIED. THE PATIENT ATTENDED CLINIC COMPLAINING OF RECURRENT CLAUDICATION SYMPTOMS IN THE LEFT LEG. AN ULTRASOUND REVEALED THAT THE STENT HAD CRITICAL STENOSES IN SEVERAL AREAS WITH SLOW FLOW. THE PATIENT RETURNED FOR AN ANGIOGRAM OF THE LEFT LEG ON (B)(6) 2023. THE EXAMINATION SHOWED MULTIPLE AREAS OF HIGH-GRADE I

  Patient problems: Pain; Restenosis

  MAUDE report 16644583 ↗
• InjuryJan 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS TREATED AS PART OF THE MIMICS 3D USA POST-MARKET OBSERVATIONAL STUDY. ON THE (B)(6) 2022, THE PATIENT WAS IMPLANTED WITH ONE BIOMIMICS 3D (BM3D) STENT (A 6.0 X 125MM STENT) TO TREAT A DENOVO LESION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) MIDDLE THIRD TO DISTAL THIRD IN THE RIGHT LEG. A CONTRALATERAL APPROACH WAS USED AND THE LESION WAS PREPARED USING ATHERECTOMY AND PRE-DILATED WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). THE 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 SFA DISTAL THIRD TO PROXIMAL POPLITEAL SEGMENT WAS TREATED WITH PTA / STANDARD BALLOON ANGIOPLASTY ON (B)(6) 2022. IT WAS REPORTED AS A TARGET LESION REVASCULARIZATION (TLR) / TARGET VESSEL REVASCULARIZATION (TVR). THE EVENT OF RESTENOSIS WAS REPORTED AS NOT RELATED TO THE DEVICE AND NOT RELATED TO THE PROCEDURE BUT WAS DUE TO A WORSENING OF THE PATIENT'S PRE-EXISTING CONDITION. IT WAS REPORTED AS TARGET LESION RELATED. THE PATIENT OUTCOME WAS REPORTED AS RESOLVED/RECOVERED AND THE DEVICE REMAINS IMPLANTED. THE EVENT WAS REVIEWED BY VERYAN ON 09-JAN-23 AND CONSIDERED POSSIBLY RELATED TO THE D

  Patient problems: Restenosis

  MAUDE report 16264091 ↗
• InjuryJan 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS TREATED AS PART OF THE MIMICS 3D USA POST-MARKET OBSERVATIONAL STUDY. ON THE (B)(6) 2021, THE PATIENT WAS IMPLANTED WITH ONE BIOMIMICS 3D (BM3D) STENT (A 6.0 X 125MM STENT) TO TREAT A DENOVO LESION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) MIDDLE THIRD TO DISTAL THIRD 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 TREATED LASER ATHERECTOMY AND ANGIOPLASTY ON THE LEFT SFA ON (B)(6) 2022. THE EVENT OF RESTENOSIS WAS REPORTED AS NOT RELATED TO THE DEVICE AND NOT RELATED TO THE PROCEDURE BUT WAS DUE TO A WORSENING OF THE PATIENT'S PRE-EXISTING CONDITION. IT WAS REPORTED AS TARGET LESION RELATED. 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.

  Patient problems: Pain; Restenosis

  MAUDE report 16264082 ↗
• InjuryDec 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS RELATED TO MDR REPORT 3011632150-2022-00112. 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 IN THE SUPERFICIAL FEMORAL ARTERY (SFA) PROXIMAL THIRD TO SFA DISTAL THIRD ARTERIAL SEGMENT AND ONE 6.0 X 125MM STENT (THE SUBJECT OF THE REPORT) 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 THE (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 IMPROVE

  Patient problems: Restenosis

  MAUDE report 15957919 ↗
• InjuryNov 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS EVENT IS RELATED TO MDR NUMBER 3011632150-2022-00083. THE PATIENT WAS ENROLLED IN THE POST-MARKET OBSERVATIONAL MIMICS 3D USA REGISTRY STUDY ON (B)(6) 2021. THE PATIENT WAS TREATED WITH ONE BIOMIMICS 3D STENT TO TREAT A DENOVO LESION OF THE SFA DISTAL THIRD TO THE PROXIMAL POPLITEAL IN THE RIGHT LEG. THE LESION WAS POST-DILATED WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). A CONTRALATERAL APPROACH WAS USED. THE PATIENT HAD A DUPLEX ULTRASOUND (DUS) TAKEN ON (B)(6) 2022 FOLLOWING HOSPITALISATION DUE TO GANGRENE ON (B)(6) 2022. THE DUS SHOWED THE STENTS WERE WIDELY PATENT BUT DIMINISHED ANKLE BRACHIAL INDEX (ABI). RESTENOSIS/OCCLUSION OF THE RUN OFF VESSELS WERE SUSPECTED TO BE THE REASON. A CT ANGIOGRAPHY (CTA) TAKEN SHOWED A LONG OCCLUSION OF THE SFA AND PROXIMAL POPLITEAL ARTERIES. THE EVENT OF GANGRENE WAS REPORTED AS POSSIBLY RELATED TO THE DEVICE AS THE LONG OCCLUSION IDENTIFIED INCLUDED THE TREATED SEGMENT. THE PATIENT WAS DISCHARGED ON (B)(6) 2022 TO A REHAB FACILITY AND A FOLLOW-UP PLAN INVOLVING VASCULAR BYPASS SURGERY WAS PLANNED. THE SUBJECT SUFFERED AN ACUTE STROKE WHILE IN THE REHAB FACILITY AND PASSED AWAY BEFORE THE VASCULAR SURGERY COULD BE CONDUCTED.

  Patient problems: Obstruction/Occlusion; Restenosis

  MAUDE report 15778281 ↗
• InjurySep 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS ENROLLED IN THE POST-MARKET OBSERVATIONAL MIMICS 3D USA REGISTRY STUDY ON (B)(6) 2021. THE PATIENT WAS TREATED WITH ONE BIOMIMICS 3D STENT TO TREAT A DENOVO LESION OF THE SFA DISTAL THIRD TO THE PROXIMAL POPLITEAL IN THE RIGHT LEG. THE LESION WAS POST DILATED WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). A CONTRALATERAL APPROACH WAS USED. THE PATIENT HAS A HISTORY OF HYPERTENSION, DIABETES MELLITUS TREATED WITH DIETARY MODIFICATIONS, RENAL INSUFFICIENCY, AND HAS HAD A NON HEALING ARTERIAL/DIABETIC WOUND ON THE RIGHT LEG. ON (B)(6) 2022 THE PATIENT WAS ADMITTED TO HOSPITAL WITH GANGRENE ON THE 3RD AND 4TH TOES OF THE RIGHT FOOT AND REDNESS AND SWELLING ON THE RIGHT FOOT AND ANKLE. AN X-RAY TAKEN SHOWED RIGHT SECOND METATARSAL DONE DISTAL SHAFT REACTION CONCERNING POSSIBLE OSTEOMYELITIS OR STRESS FRACTURE. INTRAVENOUS VANCOMYCIN AND ZOSYN WAS INITIATED AND FOLLOWING A CONSULTATION ON (B)(6) 2022 A CULTURE OF THE DRY BUT OPEN WOUND IN THE RIGHT FOOT AT THE BASE OF THE TOES SHOWED PSEUDOMONAS AND CITROBACTER. THE DIAGNOSIS WAS GANGRENE WITH POSSIBLE SECONDARY INFECTION. THE PATIENT WAS SWITCHED TO LEVOFLOXACIN THERAPY. THE DUPLEX ULATRASOUND TAKEN ON (B)(6) 2022 SHO

  Patient problems: Bacterial Infection; Infiltration into Tissue; Necrosis; Obstruction/Occlusion; Tissue Breakdown

  MAUDE report 15426796 ↗
• 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 3011632150-2022-00076. 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 AND A 6.0 X 125MM STENT (THIS REPORT) ) 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 15355428 ↗
• 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 ( 6.0 X 125MM STENT) TO TREAT A DENOVO LESION OF THE SFA MIDDLE THIRD ARTERY IN THE LEFT LEG. A CONTRALATERAL APPROACH WAS USED AND POST-DILATATION OF THE TARGET LESION WAS CONDUCTED WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) AFTER STENT PLACEMENT AND ATHERECTOMY WAS 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 WITH A RELATIONSHIP TO THE DEVICE AS "NOT ASSESSABLE/UNKNOWN" 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 STENT PLACEMENT (NON BIOMIMICS), BALLOON ANGIOPLASTY AND LASER ATHERECTOMY. 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: Restenosis

  MAUDE report 15108727 ↗
• MalfunctionJun 15, 2022Fracture; Material Deformation; Fracture; Material Deformation

  THE PATIENT HAD A 6 X 125MM BIOMIMICS 3D STENT IMPLANTED IN THE LEFT SFA ON (B)(6) 2021. THE PATIENT WAS BROUGHT BACK FOR ANGIOGRAM AND THE STENT WAS REPORTED AS FRACTURED. THE PHYSICIAN THEN RELINED THE FRACTURED 6 X 125 BIOMIMICS WITH A NON BIOMIMICS 3D STENT AND THE PATIENT IS DOING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14692562 ↗
• InjuryJun 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS TREATED AS PART OF THE (B)(6) STUDY ON (B)(6) 2021 TO TREAT A RESTENOTIC LESION IN THE SFA PROXIMAL THIRD OF THE RIGHT LEG. AN EVENT OF RESTENOSIS OF THE TREATED SEGMENT (TARGET LESION) WAS IDENTIFIED ON (B)(6) 2021. IT WAS REPORTED AS NOT RELATED TO THE DEVICE OR PROCEDURE BUT DUE TO A WORSENING OF THE PATIENT CONDITION. DOPPLER ULTRASOUND ON (B)(6) 2021 SHOWED SEVERE STENOSIS OF RIGHT SFA STENTS. A TARGET LESION REVASCULARISATION (TLR) WAS CONDUCTED ON THE (B)(6) 2021 AND INVOLVED BARE METAL STENT, DRUG COATED BALLOON/DRUG ELUTING BALLOON (DCB/DEB) AND LASER ATHERECTOMY. THE STENT WAS PLACED IN MID SFA (OUTSIDE OF TARGET LESION). THE OUTCOME OF THE EVENT IS REPORTED AS RESOLVED/RECOVERED. THE DEVICE REMAINS IMPLANTED.

  Patient problems: Pain; Restenosis

  MAUDE report 14561083 ↗
• InjuryMay 12, 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. THE SUBJECT WAS IMPLANTED WITH ONE BIOMIMICS-3D STENT (A 6.0 X 125MM) TO TREAT A DENOVO OCCLUSION OF THE SFA MIDDLE THIRD TO DISTAL THIRD IN THE LEFT LEG A CONTRALATERAL APPROACH WAS USED AND PRE-DILATATION OF THE TARGET LESION WAS CONDUCTED WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. ATHERECTOMY WAS ALSO PERFORMED PRE STENT PLACEMENT. ON THE (B)(6), AN EVENT OF RESTENOSIS OF TREATED VESSEL (TARGET VESSEL) WAS REPORTED FROM THE SITE. IT WAS REPORTED AS "NOT RELATED" TO THE DEVICE OR PROCEDURE BUT WAS TARGET LESION RELATED. PERCUTANEOUS INTERVENTION WAS CONDUCTED. THE DETAILS OF THE INTERVENTION HAVE NOT YET BEEN PROVIDED. THE COMMENTS ON THE EVENTS ARE AS FOLLOWS: "SUBJECT PRESENTED FOR AN ULTRASOUND OF (B)(6) 2022. HE COMPLAINED OF BILATERAL CLAUDICATION WITH THE LEFT WORSE THAN THE RIGHT. ULTRASOUND SHOWED A MODERATE STENOSIS IN THE LEFT SFA. THE PHYSICIAN HAS RECOMMENDED AN ANGIOGRAM AFTER SPEAKING WITH THE APRN, WHO SAW THE SUBJECT ON (B)(6) 2022. ANGIOGRAM WAS PERFORMED AND INTERVENTION WAS DON

  Patient problems: Pain; Restenosis

  MAUDE report 14375230 ↗