BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMIMICS 3D VASCULAR STENT SYSTEM

    MDR report key: 10210820 · Received June 30, 2020

    Report

    Report Number
    3011632150-2020-00033
    Event Type
    Injury
    Date Received
    June 30, 2020
    Date of Event
    May 25, 2020
    Report Date
    June 30, 2020
    Manufacturer
    VERYAN MEDICAL LTD
    Product Code
    NIP
    PMA / PMN Number
    P180003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 EFFECT OF 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

    THE PATIENT WAS TREATED AS PART OF (B)(6) STUDY ON (B)(6) 2017. AT INDEX PROCEDURE ((B)(6) 2017), THE PATIENT PRESENTED WITH A DE-NOVO OCCLUSION OF THE MIDDLE THIRD OF THE SFA SUPERFICIAL FEMORAL ARTERY OF THE LEFT LEG. ONE BIOMIMICS 3D DEVICE WAS IMPLANTED. A 7.0 X 80MM STENT. ON (B)(6) 2020 AN OCCLUSION OF THE SEGMENT INVOLVING THE SFA MIDDLE THIRD ( TREATED SEGMENT ) TO THE PROXIMAL THIRD OF THE PERONEAL ARTERY REQUIRED HOSPITALIZATION. A TARGET LESION REVASCULARISATION WITH A BYPASS/GRAFT OF THE OCCLUSION WAS CONDUCTED ON (B)(6) 2020. THE OUTCOME OF THE EVENT IS THAT IT IS RESOLVED AND THE PATIENT HAS RECOVERED. THE BIOMIMICS 3D DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676944 BIOMIMICS 3D VASCULAR STENT SYSTEM BIOMIMICS 3D VASCULAR STENT SYSTEM NIP VERYAN MEDICAL LTD 391166

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization