BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER PTX 35 DRUG-ELUTING STENT

    MDR report key: 9201985 · Received October 17, 2019

    Report

    Report Number
    3005580113-2019-00588
    Event Type
    Injury
    Date Received
    October 17, 2019
    Report Date
    October 17, 2019
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIU
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT HAS BEEN REPORTED BY THE MANUFACTURER UNDER MDR # 3001845648-2019-00546. NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING.

    Description of Event or Problem · 1

    AS REPORTED TO CUSTOMER RELATIONS: "THE FP TARGET LESIONS WERE CROSSED USING CONVENTIONAL WIRE AND CATHETER TECHNIQUES, FOLLOWED BY PREDILATION WITH A BALLOON ONE SIZE SMALLER THAN THE REFERENCE VESSEL DIAMETER TO ALLOW FOR STENT PLACEMENT. THE STENT(S) WERE POST DILATED WITH BALLOONS SIZED IN A 1:1 RATIO WITH THE NORMAL VESSEL DIAMETER. THE REINTERVENTIONS INVOLVED 7 (8%, P=0.021) FDJ PATIENTS WHO UNDERWENT SURGICAL BYPASS/REPAIR." "7/89 PATIENTS REQUIRED SURGICAL BYPASS/REPAIR."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    998166 ZILVER PTX 35 DRUG-ELUTING STENT NIU COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R