BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT

    MDR report key: 11543434 · Received March 22, 2021

    Report

    Report Number
    3005580113-2021-00040
    Event Type
    Death
    Date Received
    March 22, 2021
    Report Date
    March 22, 2021
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NIO STENT, ILIAC.

    Description of Event or Problem · 1

    MATHLOUTHI 2020, ZILVER FLEX, INCREASED MORTALITY WITH PACLITAXEL-ELUTING STENTS IS DRIVEN BY LESION LENGTH A RETROSPECTIVE REVIEW OF THE MEDICAL RECORDS OF 296 PATIENTS WHO UNDERWENT FPA STENTING BETWEEN JANUARY 2011 AND DECEMBER 2017 WAS PERFORMED. PATIENTS WERE GROUPED INTO BMS AND PES GROUPS. THE PRIMARY END POINT WAS ALL-CAUSE MORTALITY. SECONDARY END POINTS INCLUDED LIMB SALVAGE, PRIMARY PATENCY, PRIMARY ASSISTED PATENCY, AND SECONDARY PATENCY. A COMPARISON BETWEEN THE TWO GROUPS WITHIN TRANSATLANTIC INTER-SOCIETY CONSENSUS (TASC) II SUBGROUPS WAS ALSO PERFORMED. COMPARED WITH THE BMS GROUP, THE PES GROUP EXHIBITED SIGNIFICANTLY HIGHER RATES OF 2-YEAR ALL-CAUSE MORTALITY (23.9% VS 5.1%; P = .05; FIG). AFTER ADJUSTMENT FOR AGE AND OTHER POTENTIAL CONFOUNDERS, PES USE WAS ASSOCIATED WITH A TWOFOLD INCREASE IN ALL-CAUSE MORTALITY (ADJUSTED HAZARD RATIO, 2.3; 95% CI, 1.31-27; P = .02; TABLE V). THIS COMPLAINT IS CAPTURING ALL CAUSE MORTALITY IN 22 PATIENTS ((B)(4) OF 195 PATIENTS IN THE BMS GROUP)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441470 ZILVER FLEX 35 VASCULAR SELF-EXPANDING STENT FGE COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death