BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER VENA VENOUS SELF-EXPANDING STENT

    MDR report key: 11609682 · Received April 2, 2021

    Report

    Report Number
    3005580113-2021-00053
    Event Type
    Injury
    Date Received
    April 2, 2021
    Date of Event
    March 10, 2021
    Report Date
    April 2, 2021
    Manufacturer
    COOK IRELAND LTD
    Product Code
    QAN
    UDI-DI
    10827002574493
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMMON DEVICE NAME: NIO STENT, ILIAC. PRODUCT CODE: QAN

    Description of Event or Problem · 1

    ACCORDING TO THE INITIAL REPORTER, AFTER THE PHYSICIAN DEPLOYED THE STENT IN THE LEFT ILIAC, THE 1ST 75 % OF THE PROXIMAL STENT DEPLOYED WELL AND FULLY OPEN. THEN THE DISTAL 25 % OF THE STENT DID NOT FULLY OPEN AND REMAINED COMPRESSED. AFTER SEEING THIS, THE PHYSICIAN TRIED TO BALLOON THAT PART OF THE STENT MULTIPLE TIMES BUT EACH TIME, AFTER BALLOONING, THE STENT WOULD JUST COMPRESS AGAIN. AFTER THIS, THE PHYSICIAN HAD TO LINE THE INSIDE OF THE STENT WITH A COMPETITIVE STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504415 ZILVER VENA VENOUS SELF-EXPANDING STENT QAN COOK IRELAND LTD G57449 C1769826 10827002574493

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention