BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZILVER PTX 35 DRUG-ELUTING STENT

    MDR report key: 15581324 · Received October 11, 2022

    Report

    Report Number
    3005580113-2022-00107
    Event Type
    Injury
    Date Received
    October 11, 2022
    Date of Event
    September 16, 2022
    Report Date
    October 13, 2022
    Manufacturer
    COOK IRELAND LTD
    Product Code
    NIU
    UDI-DI
    10827002384832
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    SECTION C HAS BEEN UPDATED.

    Description of Event or Problem · 0

    ACCORDING TO THE INITIAL REPORTER, POST A LEG ANGIOGRAM WITH PACLITAXEL STENT PLACEMENT PROCEDURE, THE INITIAL REPORTER STATED THAT THE PATIENT CAME BACK IN WITH INDURATED SKIN LESIONS. THEY WONDER IF THE PACLITAXEL MIGHT BE RESPONSIBLE FOR THIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369999 ZILVER PTX 35 DRUG-ELUTING STENT Stent, superficial femoral artery, drug-eluting NIU COOK IRELAND LTD G38483 C1957452 10827002384832

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female Other