BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER PTX DRUG ELUTING PERIPHERAL STENT

    MDR report key: 12512932 · Received September 22, 2021

    Report

    Report Number
    3005580113-2021-00106
    Event Type
    Injury
    Date Received
    September 22, 2021
    Report Date
    September 22, 2021
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMMON DEVICE NAME: NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING.

    Description of Event or Problem · 1

    ¿IN STENT RESTENOSIS 3 YRS AFTER ZILVER PTX PLACEMENT WITH REST PAIN. ROTAREX DID A GOOD JOB CLEANING IT UP, LUTONIX DCB, POP AND TIBIAL RECAN. ABI FROM 0.2 TO 0.8, PAIN RESOLVED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1413676 ZILVER PTX DRUG ELUTING PERIPHERAL STENT FGE COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention