BioMimics 3D Vascular Stent System 144700-12Recalls & reported problems

Summary

The FDA's MAUDE database contains 74 adverse event reports that list this exact device (DI 05391526850510), received between Apr 29, 2021 and Aug 15, 2025 — classified as 59 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (8 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 74 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 15, 2025Difficult or Delayed Activation; Activation Failure; Difficult or Delayed Activation; Activation Failure

  IT WAS FURTHER REPORTED THAT THERE WERE NO ADVERSE EFFECTS ON THE PATIENT AS A RESULT OF THIS CASE.

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

  MAUDE report 22813539 ↗
• InjuryOct 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS RELATED TO MDR NUMBER 3011632150-2024-00050_01. THIS PATIENT WAS ENROLLED IN THE MIMICS 3D USA POST-MARKET OBSERVATIONAL REGISTRY STUDY. ON (B)(6) 2022, THE PATIENT WAS IMPLANTED WITH TWO BIOMIMICS 3D (BM3D) STENTS. A 6.0 X 150 MM STENT (THE SUBJECT OF THIS REPORT) WAS USED TO TREAT A DENOVO LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) DISTAL THIRD AND A 6.0 X 60 MM STENT WAS USED TO TREAT A DENOVO LESION IN THE PROXIMAL POPLITEAL. BOTH STENTS WERE PLACED IN THE RIGHT LEG. A CONTRALATERAL APPROACH WAS USED AND THE LESIONS WERE PRE-DILATED WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA). THE TREATED SEGMENTS WERE POST-DILATED WITH PTA. ON THE (B)(6) 2022, THE SITE IDENTIFIED A RESTENOSIS OF TREATED SEGMENT (TARGET LESION). IT WAS REPORTED AS NOT RELATED TO THE DEVICE AND NOT RELATED TO THE PROCEDURE BUT DUE TO A WORSENING PRE-EXISTING CONDITION. IT WAS REPORTED AS NOT SERIOUS. IT WAS REPORTED AS TARGET LESION RELATED. THE PATIENT HAD RECURRENT BILATERAL CLAUDICATION, A REPEAT ANGIOGRAM DONE ON (B)(6) 2022 SHOWED MODERATE-TO-SEVERE IN-STENT RESTENOSIS IN THE RANGE OF 70 - 80% IN SFA. IT WAS MANAGED MEDICALLY. AN UPDATE ON 16-AUG-24 REPORTED THAT DURING A CLINIC VISIT WITH

  Patient problems: Pain; Restenosis; Swelling/ Edema

  MAUDE report 20343849 ↗
• InjurySep 3, 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) 2022, THE PATIENT WAS IMPLANTED WITH ONE 6.0 X 150 MM BIOMIMICS 3D (BM3D) STENT. IT WAS USED TO TREAT A DENOVO LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) DISTAL THIRD TO PROXIMAL POPLITEAL IN THE LEFT LEG. A CONTRALATERAL APPROACH WAS USED AND THE TREATED SEGMENT WAS PRE-DILATED WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) AND ATHECTOMY WAS USED. THE TREATED SEGMENT WAS POST-DILATED WITH PTA. ON THE 05-DEC-23, THE SITE IDENTIFIED A RESTENOSIS OF TREATED SEGMENT (TARGET LESION). IT WAS REPORTED AS NOT RELATED TO THE DEVICE OR THE PROCEDURE BUT WAS DUE TO A WORSENING PRE-EXISTING CONDITION. IT REQUIRED PERCUTANEOUS INTERVENTION. IT WAS REPORTED AS TARGET LESION RELATED. THE PATIENT HAD 80% STENOSIS IN THE MID TO DISTAL SFA AND PROXIMAL EDGE OF STENT IN PROXIMAL SFA. THE EVENT WAS TREATED ON 05-DEC-23 AND INVOLVED PTA/STANDARD BALLOON ANGIOPLASTY AND LASER/ATHERECTOMY. THIS INTERVENTION WAS A TARGET LESION/VESSEL REVASCULARISATION (TLR/TVR). THE ANTERIOR TIBIAL (AT) PROXIMAL THIRD TO DISTAL THIRD WAS ALSO TREATED WITH LASER/ATHERECTOMY. THE OUTCOME WAS REPORTED AS RESOLVED/RECOVE

  Patient problems: Restenosis

  MAUDE report 20124127 ↗
• InjurySep 3, 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 08-JUL-21, THE PATIENT WAS IMPLANTED WITH ONE 6.0 X 150 MM BIOMIMICS 3D (BM3D) STENT. IT WAS USED TO TREAT A RESTENOTIC LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) DISTAL THIRD TO PROXIMAL POPLITEAL IN THE RIGHT LEG. A CONTRALATERAL APPROACH WAS USED AND THE TREATED SEGMENT WAS PRE-DILATED WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) AND POST-DILATED WITH PTA AND A LUTONIX DRUG COATED BALLOON (DCB). ON 12-JUL-24, THE SITE IDENTIFIED AN EVENT OF LIMB ISCHEMIA. IT WAS REPORTED AS NOT RELATED TO THE DEVICE OR THE PROCEDURE BUT WAS DUE TO A WORSENING PRE-EXISTING CONDITION. IT REQUIRED PERCUTANEOUS INTERVENTION AND THROMBOLYTICS. IT WAS REPORTED AS TARGET LESION RELATED. THE PATIENT HAD COMPLAINTS OF WORSENING SYMPTOMS OF ELEVATION PALLOR, DEPENDENT RUBOR, PAIN IN RIGHT FOOT WHICH HAD SLOWLY WORSENED OVER THE LAST 3 WEEKS. PATIENT HAD RUTHERFORD CLASS IV SYNPTOMS (RB IV). COMPUTED TOMOGRAPHY (CT) SCAN ON 21-JUN-24 WAS REVIEWED AND SHOWED OCCLUDED RIGHT DISTAL SFA AND THE POPLITEAL IS OCCLUDED. URGENT REVASCULARISATION OF THE RIGHT SFA WAS PLANNED. THE PATIENT DID END UP IN THE EMERGENCY D

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

  MAUDE report 20124125 ↗
• InjurySep 3, 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 6.0 X 150 MM BIOMIMICS 3D (BM3D) STENT. IT WAS USED TO TREAT A RESTENOTIC LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) DISTAL THIRD TO PROXIMAL POPLITEAL IN THE RIGHT LEG. A CONTRALATERAL APPROACH WAS USED AND THE TREATED SEGMENT WAS PRE-DILATED WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) AND POST-DILATED WITH PTA AND A LUTONIX DRUG COATED BALLOON (DCB). ON THE (B)(6) 2024, THE SITE IDENTIFIED AN OCCLUSION. IT WAS REPORTED AS NOT RELATED TO THE DEVICE OR THE PROCEDURE BUT WAS DUE TO A WORSENING PRE-EXISTING CONDITION. IT REQUIRED PERCUTANEOUS INTERVENTION AND THROMBOLYTICS. IT WAS REPORTED AS TARGET LESION RELATED. THE PATIENT HAD COMPLAINTS OF WORSENING SYMPTOMS OF ELEVATION PALLOR, DEPENDENT RUBOR, PAIN IN RIGHT FOOT WHICH HAD SLOWLY WORSENED OVER THE LAST 3 WEEKS. PATIENT HAD RUTHERFORD CLASS IV SYMPTOMS (RB IV). COMPUTED TOMOGRAPHY (CT) SCAN ON (B)(6) 2024 WAS REVIEWED AND SHOWED OCCLUDED RIGHT DISTAL SFA AND THE POPLITEAL IS OCCLUDED. URGENT REVASCULARISATION OF THE RIGHT SFA WAS PLANNED. THE PATIENT DID END UP IN THE EMERGENCY DEPA

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

  MAUDE report 20124124 ↗
• 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 150 MM STENT TO TREAT A RESTENOTIC LESION IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA) DISTAL THIRD TO PROXIMAL POPLITEAL ARTERY. A CONTRALATERAL APPROACH WAS USED AND THE LESION WAS PRE-DILATED WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) AND ATHERECTOMY. ON (B)(6) 2022, A RESTENOSIS OF THE TREATED SEGMENT (TARGET LESION) WAS IDENTIFIED AND IT WAS REPORTED AS POSSIBLY RELATED TO THE DEVICE AND NOT RELATED TO THE PROCEDURE. IT WAS TARGET LESION-RELATED. IT REQUIRED LASER ATHERECTOMY OF THE SFA MIDDLE THIRD TO THE POSTERIOR TIBIAL PROXIMAL THIRD ON (B)(6) 2022. THE INTERVENTION WAS A TARGET LESION/VESSEL REVASCULARISATION (TLR/TVR). THE OUTCOME WAS REPORTED AS RESOLVED/RECOVERED. THE DEVICE REMAINS IMPLANTED. VERYAN BECAME AWARE OF THIS EVENT ON (B)(6) 2024.

  Patient problems: Restenosis

  MAUDE report 19094753 ↗
• InjuryFeb 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD INTERMITTENT CLAUDICATION IN THE LOWER LIMBS SINCE AUTUMN 2022 AND WAS REFERRED TO THE HOSPITAL ON (B)(6) 2023 FOR FURTHER EXAMINATION AS THE PATIENT'S ANKLE-BRACHIAL INDEX (ABI) VALUES WERE LOW AS RECOGNISED BY THE PREVIOUS PHYSICIAN. ENDOVASCULAR TREATMENT (EVT) WAS SCHEDULED BECAUSE A SIGNIFICANT STENOTIC LESION WAS FOUND IN THE RIGHT FEMORAL ARTERY VIA VASCULAR ULTRASOUND. ON (B)(6) 2023 THE PATIENT WAS ADMITTED TO HOSPITAL FOR EVT. THE PATIENT CONSENTED TO TREATMENT THAT INVOLVED THE IMPLANTATION OF A BIOMIMICS 3D (BM3D) STENT. THE LESION WAS PREPARED WITH PLAIN OLD BALLOON ANGIOPLASTY (POBA) ON THE RIGHT FEMORAL ARTERY AND A BM3D 6.0 X 150 MM STENT WAS PLACED. THE PROCEDURE WAS COMPLETED WITHOUT ANY COMPLICATIONS. THE PATIENT WAS STARTED ON 200MG CILOSTAZOL TABLETS ORALLY PER DAY ON (B)(6) 2023. THEY WERE DISCHARGED ON (B)(6) 2023 AFTER A GOOD POST-OPERATIVE COURSE. ON (B)(6) 2023, 30 DAYS AFTER THE PROCEDURE, THE PATIENT VISITED THE HOSPITAL AS SCHEDULED. THEY HAD NO INTERMITTENT CLAUDICATION SYMPTOMS. THE BLOOD FLOW IN THE LOWER LIMBS WAS GOOD ACCORDING TO ABI AND DUPLEX ULTRASOUND (DUS). ON (B)(6) 2023, THE PATIENT VISITED THE HOSPITAL 6 MONTHS AFTER THE PR

  Patient problems: Pain; Restenosis

  MAUDE report 18729871 ↗
• 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) 2022, THE PATIENT WAS IMPLANTED WITH ONE BIOMIMICS 3D (BM3D) STENT IN THE LEFT LEG, A 6.0 X 150 MM STENT WHICH WAS USED TO TREAT A DENOVO LESION IN THE SUPERFICIAL FEMORAL ARTERY (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 VESSEL (TARGET VESSEL) EVENT ON 14-NOV-22. 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. ON (22, DUPLEX ULTRASOUND (DUS) SHOWED STENOSIS IN THE DISTAL SFA. THE PATIENT WAS ALSO SYMPTOMATIC, COMPLAINING OF BILATERAL LOWER EXTREMITY PAIN WHERE THE LEFT WAS WORSE THAN THE RIGHT, AND THE PATIENT ALSO EXPERIENCED WEAKNESS/CRAMPING. THE PATIENT UNDERWENT AN INTERVENTION ON (B)(6) 2022. LASER ATHERECTOMY AND PTA/STANDARD BALLOON ANGIOPLASTY WERE PERFORMED THROUGHOUT THE VESSEL FROM THE ANTERIOR TIBIAL DISTAL THIRD TO THE SFA DISTAL THIRD. THERE

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

  MAUDE report 18612699 ↗
• 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 05-APR-21, THE PATIENT WAS IMPLANTED WITH ONE BIOMIMICS 3D (BM3D) STENT IN THE LEFT LEG, A 6.0 X 150 MM STENT WHICH WAS USED TO TREAT A RESTENOTIC LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) PROXIMAL THIRD TO 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 SITE IDENTIFIED A RESTENOSIS OF TREATED SEGMENT (TARGET LESION) EVENT ON 22-JUL-21. 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) 2021, WITH DRUG COATED BALLOON / DRUG ELUTING BALLOON (DCB/DEB), PTA / STANDARD BALLOON ANGIOPLASTY AND LASER/ATHERECTOMY WHICH WERE PERFORMED ON THE SFA OSTIAL TO DORSALIS PEDIS 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 27-DEC-2023 AND IT WAS REVIEWED BY VERYAN IN JAN 2024 AND CONSIDERED RELATED TO THE DEVICE.

  Patient problems: Restenosis

  MAUDE report 18581529 ↗
• InjuryDec 12, 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 150MM BIOMIMICS 3D (BM3D) STENT. IT WAS USED TO TREAT A RESTENOTIC LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) MIDDLE 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 CUTTING BALLOON. THE TREATED SEGMENT WAS POST-DILATATION WITH PTA. ON THE 21-JUN-23, AN EVENT OF RESTENOSIS OF TREATED SEGMENT (TARGET LESION) WAS IDENTIFIED. IT WAS SITE REPORTED AS POSSIBLY RELATED TO THE DEVICE AND NOT RELATED TO THE PROCEDURE. IT WAS TARGET LESION RELATED. IT REQUIRED INTERVENTION ON (B)(6) 2023. THE IN-STENT STENOSIS OF THE POPLITEAL ARTERY WAS TREATED WITH A 6 X 60 INPACT DRUG COATED/ELUTING BALLOON CATHETER (DCB/DEB) INFLATED TO NOMINAL PRESSURES FOR 3 MINUTES. THE PROXIMAL POPLITEAL TO DISTAL POPLITEAL WAS THE ARTERIAL SEGMENT THAT WAS TREATED. A COMPLETION ANGIOGRAM WAS THEN PERFORMED WHICH SHOWED RESOLUTION OF THE IN-STENT STENOSIS AND IN LINE FLOW TO THE DISTAL POSTERIOR TIBIAL ARTERY. IT WAS REPORTED

  Patient problems: Restenosis

  MAUDE report 18310894 ↗
• InjuryNov 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE MALE PATIENT WAS IMPLANTED WITH ONE 6.0 X 150MM BIOMIMICS 3D STENT (BM3D) ON AN UNSPECIFIED DATE IN (B)(6) TO TREAT A DE NOVO LESION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) MIDDLE THIRD IN THE LEFT LEG. ON THE (B)(6) 2023, THE PATIENT ARRIVED TO THE CLINIC AND PRESENTED WITH LEFT LEG PAIN. AN EVENT OF RESTENOSIS WAS IDENTIFIED DURING AN ULTRASOUND. THE RESTENOSIS RATE WAS APPROXIMATELY 90%. IN (B)(6) 2023, ENDOVASCULAR TREATMENT (EVT) WAS PERFORMED. AN ANGIOGRAM SHOWED THE EVENT WAS AN IN-STENT RESTENOSIS (ISR). PLAIN OLD BALLOON ANGIOPLASTY (POBA) WAS PERFORMED USING A NC BALLOON, AND THE INSIDE OF THE STENT WAS DILATED WITH A DRUG COATED BALLOON (DCB). THE PATIENT'S PROGRESS IS BEING MONITORED.

  Patient problems: Pain; Restenosis

  MAUDE report 18208240 ↗
• InjuryNov 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS RELATED TO MDR NUMBER 3011632150-2023-00131. 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 150MM BIOMIMICS 3D (BM3D) STENTS. THEY WERE USED TO TREAT A DENOVO LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) OSTIAL TO DISTAL POPLITEAL IN THE RIGHT LEG. THE BM3D DEVICE IS ONLY INDICATED FOR USE IN THE NATIVE SFA AND PROXIMAL POPLITEAL ARTERY. 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 EVENT OF RESTENOSIS OF TREATED SEGMENT (TARGET LESION) WAS IDENTIFIED. IT WAS SITE REPORTED AS POSSIBLY RELATED TO THE DEVICE AND NOT RELATED TO THE PROCEDURE AND IT WAS TARGET LESION RELATED. IT REQUIRED PERCUTANEOUS INTERVENTION ON (B)(6) 2022, THAT INVOLVED PTA/STANDARD BALLOON ANGIOPLASTY AND LASER ATHERECTOMY ON THE SFA PROXIMAL TO THE ANTERIOR TIBIAL DISTAL THIRD SEGMENT. IT WAS REPORTED AS A TARGET LESION/VESSEL REVASCULARISATION (TLR/TVR). THE PATIENT OUTCOME WAS REPORTED AS RESOLVED/RECOVERED AND THE DEVICES R

  Patient problems: Restenosis

  MAUDE report 18145382 ↗
• InjuryNov 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS RELATED TO MDR NUMBER 3011632150-2023-00132. 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 150MM BIOMIMICS 3D (BM3D) STENTS. THEY WERE USED TO TREAT A DENOVO LESION IN THE SUPERFICIAL FEMORAL ARTERY (SFA) OSTIAL TO DISTAL POPLITEAL IN THE RIGHT LEG. THE BM3D DEVICE IS ONLY INDICATED FOR USE IN THE NATIVE SFA AND PROXIMAL POPLITEAL ARTERY. 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 THE (B)(6) 2022, AN EVENT OF RESTENOSIS OF TREATED SEGMENT (TARGET LESION) WAS IDENTIFIED. IT WAS SITE REPORTED AS POSSIBLY RELATED TO THE DEVICE AND NOT RELATED TO THE PROCEDURE AND IT WAS TARGET LESION RELATED. IT REQUIRED PERCUTANEOUS INTERVENTION ON (B)(6) 2022, THAT INVOLVED PTA/STANDARD BALLOON ANGIOPLASTY AND LASER ATHERECTOMY ON THE SFA PROXIMAL TO THE ANTERIOR TIBIAL DISTAL THIRD SEGMENT. IT WAS REPORTED AS A TARGET LESION/VESSEL REVASCULARISATION (TLR/TVR). THE PATIENT OUTCOME WAS REPORTED AS RESOLVED/RECOVERED AND THE DEVIC

  Patient problems: Restenosis

  MAUDE report 18145381 ↗
• 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 3011632150-2023-00122. 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 (THE SUBJECT OF THIS REPORT) AND ONE 6.0 X 125 MM 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 17865100 ↗
• 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 3011632150-2023-00121 AND 3011632150-2023-00122. THE PATIENT WAS TREATED AS PART OF THE MIMICS 3D USA POST-MARKET OBSERVATIONAL STUDY. ON (B)(6) 2021, THE PATIENT WAS IMPLANTED WITH THREE BIOMIMICS 3D (BM3D) STENTS IN THE RIGHT LEG, TWO 6.0 X 150 MM STENTS (THE SUBJECT OF THIS REPORT) AND ONE 6.0 X 125 MM 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 THE R

  Patient problems: Pain; Restenosis

  MAUDE report 17865094 ↗
• InjurySep 6, 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 17-JAN-22, THE PATIENT WAS IMPLANTED WITH ONE BIOMIMICS 3D (BM3D) STENT IN THE LEFT LEG, A 6.0 X 150 MM STENT WHICH WAS USED TO TREAT A DENOVO LESION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) MIDDLE THIRD TO PROXIMAL POPLITEAL. A CONTRALATERAL APPROACH WAS USED AND THE LESION WAS PREPARED USING PRE-DILATION WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON AND ATHERECTOMY. THE TREATED SEGMENT WAS POST-DILATED WITH PTA AND A BOSTON SCIENTIFIC DRUG COATED/ELUTING BALLOON (DCB/DEB). A BOSTON SCIENTIFIC BARE METAL STENT WAS ALSO PLACED POST BM3D IMPLANTATION. THE SITE IDENTIFIED A RESTENOSIS OF TREATED SEGMENT (TARGET LESION) ON (B)(6) 2023. IT WAS REPORTED AS NOT RELATED TO THE DEVICE AND NOT RELATED TO THE PROCEDURE. IT WAS REPORTED AS BEING DUE TO A WORSENING PRE-EXISTING CONDITION. IT WAS TARGET LESION RELATED. THE PATIENT PRESENTED TO THE OFFICE FOR 6-MONTH FOLLOW-UP BILATERAL LOWER EXTREMITY ULTRASOUND (US). THE PATIENT STATED TO THE US TECHNICIAN THAT HE HAD COMPLAINTS OF BILATERAL CLAUDICATION. THE US SHOWED STENOSIS OF THE SFA IN THE LEFT LOWER EXTREMITY (LLE). THE PATIENT HAD A

  Patient problems: Pain; Restenosis

  MAUDE report 17688777 ↗
• 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 3011632150-2023-00105. 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 (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. ON (B)(6) 2022 AN ADDITIONAL 6.0 X 125 MM BM3D STENT WAS PLACED IN THE SFA MIDDLE THIRD TO PROXIMAL POPLITEAL TO TREAT A RESTENOSIS. THE SITE REPORTED THAT ON 26-JUN-23, 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 SOME

  Patient problems: Ischemia; Pain; Restenosis

  MAUDE report 17496588 ↗
• 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 3011632150-2023-00098. 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 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 (THE SUBJECT OF THIS REPORT) 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 17451077 ↗
• InjuryJul 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS RELATED TO MDR NUMBER 3011632150-2023-00080. THE PATIENT WAS TREATED AS PART OF THE MIMICS 3D USA POST-MARKET OBSERVATIONAL STUDY. ON (B)(6) 2021, THE PATIENT WAS IMPLANTED WITH TWO BIOMIMICS 3D (BM3D) STENTS, A 5.0 X 150 MM STENT AND A 6.0 X 150 MM (THE SUBJECT OF THIS REPORT) STENT WHICH WERE USED TO TREAT A RESTENOTIC LESION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) MIDDLE THIRD TO PROXIMAL POPLITEAL ARTERY 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 AND A DRUG COATED / DRUG ELUTING BALLOON (DCB / DEB). THE SITE IDENTIFIED A RESTENOSIS OF TREATED SEGMENT (TARGET LESION) ON (B)(6) 2022. 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. THE PATIENT HAD THEIR LEFT POPLITEAL, LEFT SFA AND LEFT POSTERIOR TIBIAL (PT) ARTERY REVASCULARISED USING PTA / STANDARD BALLOON ANGIOPLASTY, DCB / DEB AND SHOCKWAVE TREATMENT ON THE SFA PROXIMAL THIRD TO PT DISTAL THIRD ON (B)(6) 2022. THE INTERVENTION WAS REPORTED A

  Patient problems: Restenosis

  MAUDE report 17256270 ↗
• InjuryJul 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS RELATED TO MDR NUMBER 3011632150-2023-00082. THE PATIENT WAS TREATED AS PART OF THE MIMICS 3D USA POST-MARKET OBSERVATIONAL STUDY. ON THE (B)(6) 2021, THE PATIENT WAS IMPLANTED WITH TWO BIOMIMICS 3D (BM3D) STENTS, A 5.0 X 150 MM STENT AND A 6.0 X 150 MM STENT (THE SUBJECT OF THIS REPORT) WHICH WERE USED TO TREAT A RESTENOTIC LESION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) MIDDLE THIRD TO PROXIMAL POPLITEAL ARTERY 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 AND A DRUG COATED/ DRUG ELUTING BALLOON (DCB/DEB). 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. THE PATIENT HAD THEIR LEFT POPLITEAL AND LEFT SFA REVASCULARISED USING PTA / STANDARD BALLOON ANGIOPLASTY, DCB/DEB, LASER ATHERECTOMY AND NON BM3D BARE METAL COVERED STENT PLACEMENT ON THE SFA OSTIAL TO POSTERIOR TIBIAL (PT) DISTAL THIRD ON (B)(6) 2023. THE INTERVENT

  Patient problems: Restenosis

  MAUDE report 17254636 ↗
• InjuryJun 9, 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 150MM STENT WHICH WAS USED TO TREAT A RESTENOTIC LESION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) MIDDLE THIRD IN THE LEFT LEG. A CONTRALATERAL APPROACH WAS USED AND THE LESION WAS PREPARED USING PREDILATION WITH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON AND ATHERECTOMY. THE TREATED SEGMENT WAS ALSO 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 TARGET LESION RELATED. THE PATIENT RETURNED TO THE CLINIC ON (B)(6) 2022 FOR FOLLOW-UP. THEY COMPLAINED ABOUT ACHING IN THE ACHILLES AFTER WALKING FOR 15 MINUTES ALONG WITH DISCOMFORT AT THE BASE OF THE LEFT TOES. AN ULTRASOUND SHOWED STENOSIS IN THE DISTAL PORTION OF THE LEFT SFA STENT (TARGET LEG). THE ANKLE BRACHIAL INDEXES (ABIS) ON THE LEFT DROPPED FROM 0.99 TO 0.60. AN ANGIOGRAM ON (B)(6) 2022 REVEALED A MID SFA STENT WHICH HAD AN AREA OF HIGH GRADE STENOSIS OF ABOUT 80% IN THE PROXIMAL PORTION AND MORE DI

  Patient problems: Discomfort; Pain; Restenosis

  MAUDE report 17098144 ↗
• 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 3011632150-2023-00058 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 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 (THE SUBJECT OF THIS REPORT) 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 16916430 ↗
• InjuryMay 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS EVENT IS RELATED TO MDR REPORT NUMBER (B)(4).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 150MM STENT WHICH WAS USED TO TREAT A DENOVO LESION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) MIDDLE THIRD TO DISTAL 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. IT WAS REPORTED AS DEFINITELY RELATED TO THE DEVICE AND NOT RELATED TO THE PROCEDURE. IT WAS REPORTED AS TARGET LESION RELATED AND REQUIRED PERCUTANEOUS INTERVENTION. THE PATIENT HAD A SIX MONTH DUPLEX ULTRASOUND (DUS) ON THE (B)(6) 2022 WHICH SHOWED SEVERE STENOSIS OF THE TARGET LESION (TL) STENT. THE PATIENT WAS EXPERIENCING BILATERAL LOWER EXTREMITY EDEMA. A DIAGNOSTIC ANGIOGRAM ON THE (B)(6) 2022 SHOWED SEVERE STENOSIS (99%) IN THE MID SFA JUST PROXIMAL TO THE TARGET LESION STENT AND MODERATE IN-STENT RESTENOSIS (ISR)

  Patient problems: Restenosis

  MAUDE report 16907348 ↗
• InjuryMay 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS EVENT IS RELATED TO MDR REPORT NUMBER 3011632150-2023-00057. 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 DENOVO LESION OF THE SUPERFICIAL FEMORAL ARTERY (SFA) MIDDLE THIRD TO DISTAL 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 VESSEL (TARGET VESSEL) WAS IDENTIFIED. IT WAS REPORTED AS POSSIBLY RELATED TO THE DEVICE AND NOT RELATED TO THE PROCEDURE. IT WAS REPORTED AS TARGET LESION RELATED AND REQUIRED PERCUTANEOUS INTERVENTION. THE PATIENT HAD A SIX-MONTH DUPLEX ULTRASOUND (DUS) ON (B)(6) 2022, WHICH SHOWED SEVERE STENOSIS OF THE TARGET LESION (TL) STENT. THE PATIENT WAS EXPERIENCING BILATERAL LOWER EXTREMITY EDEMA. A DIAGNOSTIC ANGIOGRAM ON (B)(6) 2022, SHOWED SEVERE STENOSIS (99%) IN THE MID SFA JUST PROXIMAL TO THE TARGET LESION STENT AND MODERATE IN-STENT RESTENOSIS (IS

  Patient problems: Restenosis

  MAUDE report 16907343 ↗
• InjuryApr 21, 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 150MM STENT WHICH WAS USED 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 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) 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 AND REQUIRED PERCUTANEOUS INTERVENTION. THE PATIENT ATTENDED THE OFFICE ON (B)(6) 2023 WITH RECURRENT PAIN IN BOTH LEGS. A COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) WAS COMPLETED FOUR DAYS BEFORE ON (B)(6) 2023 AND IDENTIFIED SEVERE STENOSIS IN BOTH LEGS. ON (B)(6) 2023, A LEFT LEG (NON STUDY LEG) ANGIOGRAM AND INTERVENTION WAS COMPLETED. ON THE (B)(6) 2023, THE PATIENT RETURNED FOR A RIGHT LEG (TARGET LEG) ANGIOGRAM AS WELL AS INTRAVASCULAR ULTRASOU

  Patient problems: Pain; Restenosis

  MAUDE report 16785429 ↗