BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOMIMICS VASCULAR STENT SYSTEM

    MDR report key: 14788655 · Received June 22, 2022

    Report

    Report Number
    MW5110473
    Event Type
    Malfunction
    Date Received
    June 22, 2022
    Report Date
    June 20, 2022
    Manufacturer
    VERYAN MEDICAL LTD / VERYAN MEDICAL
    Product Code
    NIP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PART OF THE STENT BROKE OFF IN THE BODY DURING ATTEMPT AT RETRIEVAL. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1091492 BIOMIMICS VASCULAR STENT SYSTEM STENT, SUPERFICIAL FEMORAL ARTERY NIP VERYAN MEDICAL LTD / VERYAN MEDICAL 0000131305

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Other