BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER PTX 35 DRUG-ELUTING STENT

    MDR report key: 9199590 · Received October 16, 2019

    Report

    Report Number
    3005580113-2019-00586
    Event Type
    Injury
    Date Received
    October 16, 2019
    Report Date
    October 16, 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 PREVIOUSLY REPORTED BY THE MANUFACTURER UNDER MDR # 3001845648-2019-00545. NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING - [FULL DRUG-ELUTING STENT JACKET TWO-YEAR RESULTS OF A SINGLE-CENTER EXPERIENCE.PDF].

    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 NEED FOR TLR CONTINUED TO BE SIGNIFICANTLY LOWER IN THE SL COMPARED TO THE FDJ." "11/89 PATIENTS REQUIRED REINTERVENTION AFTER 1 YEAR AND 21/89 REQUIRED REINTERVENTION AFTER 2 YEARS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    992974 ZILVER PTX 35 DRUG-ELUTING STENT NIU COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention