BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN

    MDR report key: 9199309 · Received October 16, 2019

    Report

    Report Number
    3005580113-2019-00582
    Event Type
    Death
    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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMMON DEVICE NAME: NIU STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING D2B. PRODUCT CODE: NIU. EVENT HAS BEEN REPORTED BY THE MANUFACTURER UNDER MDR#3001845648-2019-00537.

    Description of Event or Problem · 1

    THIS STUDY CONDUCTED A COMPARATIVE EFFECTIVENESS ANALYSIS OF ZILVER PTX AND CONTEMPORARY BMS FOR FEMOROPOPLITEAL ARTERY ENDOVASCULAR INTERVENTION USING THE MULTICENTER EXCELLENCE IN PERIPHERAL ARTERY DISEASE (XLPAD). THIS STUDY COMPARED CLINICALLY DRIVEN 1-YEAR TARGET-LESION REVASCULARIZATION (TLR), TARGET-VESSEL REVASCULARIZATION (TVR), AND TARGET-LIMB REVASCULARIZATION RATES BETWEEN ZILVER PTX STENT AND BMS TREATMENTS IN FEMOROPOPLITEAL DISTRIBUTION. THEY ALSO COMPARED 1-YEAR ALL-CAUSE MORTALITY IN THE RESPECTIVE TREATMENT GROUPS. THE STUDY EXTRACTED DATA FROM THE AVAILABLE 969 XLPAD REGISTRY PATIENTS WHO UNDERWENT FEMOROPOPLITEAL STENT INTERVENTIONS (UNMATCHED DATA) BETWEEN OCTOBER 2013 AND DECEMBER 2016 AT ELEVEN XLPAD PARTICIPATING SITES IN THE UNITED STATES. ONE-YEAR ALL-CAUSE MORTALITY AND THREE REVASCULARIZATION OUTCOMES ¿ CLINICALLY DRIVEN TLR, TVR, AND TARGET-LIMB REVASCULARIZATION ¿ WERE INCLUDED IN THE ANALYSIS. 174 ZILVER PTXS AND 174 BMSS WERE USED IN THIS STUDY. THE BMS GROUP CONTAINED 53 ZILVER BARE METAL STENTS. THE 1-YEAR DEATH EVENTS IN THE ZILVER PTX GROUP INCLUDED 2 CARDIOVASCULAR AND 3 ADDITIONAL UNDETERMINED CAUSES OF DEATH. THE ZILVER PTX GROUP HAD A SIGNIFICANTLY HIGHER ALL-CAUSE MORTALITY RATE THAN THE BMS GROUP. ALL CARDIOVASCULAR DEATHS HAPPENED BETWEEN 58 AND 84 DAYS POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    993547 UNKNOWN NIU COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death