BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR RX CORONARY STENT SYSTEM

    MDR report key: 1696193 · Received May 20, 2010

    Report

    Report Number
    2953200-2010-00881
    Event Type
    Death
    Date Received
    May 20, 2010
    Date of Event
    October 31, 2008
    Report Date
    April 21, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). EVALUATION RESULTS: DEATH, REVASCULARIZATION.

    Description of Event or Problem · 1

    PT RECEIVED AN ENDEAVOR RX DRUG-ELUTING STENT. PT IS REPORTED TO HAVE UNDERGONE A RE-PCI POST STENT IMPLANT. APPROXIMATELY 1 MONTH POST INDEX PROCEDURE, PT DEATH IS REPORTED TO HAVE OCCURRED. CAUSE OF DEATH IS REPORTED AS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR RX CORONARY STENT SYSTEM NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Death| R