BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMIMICS 3D VASCULAR STENT SYSTEM

    MDR report key: 9203196 · Received October 17, 2019

    Report

    Report Number
    3011632150-2019-00106
    Event Type
    Injury
    Date Received
    October 17, 2019
    Date of Event
    September 12, 2018
    Report Date
    July 21, 2021
    Manufacturer
    VERYAN MEDICAL
    Product Code
    NIP
    PMA / PMN Number
    P180003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE DATE OF ONSET OF THE EVENT WAS UPDATED BY THE CLINICAL SITE FROM (B)(6) 2018 TO THE (B)(6) 2018. AS A RESULT THE DATE OF EVENT AND THE DESCRIPTION OF THE EVENT (SECTIONS B.3 AND B.5) HAVE BEEN UPDATED.

    Description of Event or Problem · 0

    THIS IS THE SAME CASE AS MDR NUMBERS 3011632150-2019-00105 AND 3011632150-2019-00107. THE PATIENT WAS TREATED AS PART OF THE MIMICS-3D EUROPEAN POST-MARKET OBSERVATIONAL STUDY ON (B)(6) 2018. AT INDEX PROCEDURE ((B)(6) 2018), THE PATIENT PRESENTED WITH A DE-NOVO OCCLUSION LOCATED IN THE MIDDLE THIRD OF THE SUPERFICIAL FEMORAL ARTERY (SFA) TO THE PROXIMAL POPLITEAL ARTERY OF THE LEFT LEG. A 5.0 X 80 MM BIOMIMICS 3D STENT, A 6.0 X 125MM BIOMIMICS 3D STENT AND A 6.0 X 80MM BIOMIMICS 3D STENT WERE IMPLANTED. ON (B)(6) 2019 AN OCCLUSION WAS REPORTED TO VERYAN WITH A DATE OF ONSET OF (B)(6) 2018. ANGIOGRAPHY WAS REPORTED AS HAVING BEEN TAKEN ON (B)(6) 2018 AND A PTA WAS PLANNED BUT THE PATIENT WAS TREATED WITH A SURGICAL BYPASS OF THE COMMON FEMORAL TO THE DISTAL THIRD OF THE PERONEAL SEGMENT ON (B)(6) 2018. ON (B)(6) 2019 UPDATED INFORMATION WAS RECEIVED UPDATING THE ORIGINALLY REPORTED OCCLUSION TO "RESTENOSIS OF THE TREATED SEGMENT (TARGET LESION)". THE OUTCOME OF THE EVENT IS THAT IT HAS RESOLVED AND PATIENT HAS RECOVERED.

    Additional Manufacturer Narrative · 1

    THIS IS THE SAME CASE AS MDR NUMBERS 3011632150-2019-00105 AND 3011632150-2019-00107. THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. BASED ON THE CASE INFORMATION AND RELATED RECORD REVIEW, A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THE REPORTED PATIENT EFFECTS OF CLAUDICATION AND OCCLUSION/RESTENOSIS ARE LISTED IN THE BIOMIMICS 3D INSTRUCTIONS FOR USE AND ARE KNOWN PATIENT EFFECTS OF PERIPHERAL STENTING PROCEDURES. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE OR LABELLING OF THE DEVICE. IF FURTHER INFORMATION REGARDING THIS EVENT BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS IS THE SAME CASE AS MDR NUMBERS 3011632150-2019-00105 AND 3011632150-2019-00107. THE PATIENT WAS TREATED AS PART OF THE (B)(6) POST-MARKET OBSERVATIONAL STUDY ON (B)(6) 2018. AT INDEX PROCEDURE (B)(6) 2018), THE PATIENT PRESENTED WITH A DE-NOVO OCCLUSION LOCATED IN THE MIDDLE THIRD OF THE SUPERFICIAL FEMORAL ARTERY (SFA) TO THE PROXIMAL POPLITEAL ARTERY OF THE LEFT LEG. A 5.0 X 80 MM BIOMIMICS 3D STENT, A 6.0 X 125MM BIOMIMICS 3D STENT AND A 6.0 X 80MM BIOMIMICS 3D STENT WERE IMPLANTED. ON (B)(6) 2019 AN OCCLUSION WAS REPORTED TO VERYAN WITH A DATE OF ONSET OF (B)(6) 2018. ANGIOGRAPHY WAS REPORTED AS HAVING BEEN TAKEN ON (B)(6) 2018 AND A PTA WAS PLANNED BUT THE PATIENT WAS TREATED WITH A SURGICAL BYPASS OF THE COMMON FEMORAL TO THE DISTAL THIRD OF THE PERONEAL SEGMENT ON (B)(6) 2018. ON 25-SEPTEMBER-2019 UPDATED INFORMATION WAS RECEIVED UPDATING THE ORIGINALLY REPORTED OCCLUSION TO "RESTENOSIS OF THE TREATED SEGMENT (TARGET LESION)". THE OUTCOME OF THE EVENT IS THAT IT HAS RESOLVED AND PATIENT HAS RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    995851 BIOMIMICS 3D VASCULAR STENT SYSTEM BIOMIMICS 3D VASCULAR STENT SYSTEM NIP VERYAN MEDICAL 412999

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Required Intervention ASPIRIN| CALCIPARIN 12500| CLEXANE 0.2 ML| HEPARIN 5000 I.E.| MONOEMBOLEX S.C. 8000| MONOEMBOLEX S.C. 8000 I.E.| XARELTO| XARELTO| XARELTO/RIVAROXABAN