BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR RX

    MDR report key: 3010129 · Received March 19, 2013

    Report

    Report Number
    9612164-2013-00303
    Event Type
    Death
    Date Received
    March 19, 2013
    Date of Event
    April 3, 2012
    Report Date
    February 21, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: INHERENT RISK OF PROCEDURE - (CVA/STROKE). EVALUATION CONCLUSIONS: INHERENT RISK OF PROCEDURE - (CVA/STROKE). (B)(4).

    Description of Event or Problem · 1

    DURING THE INDEX PROCEDURE, THERE WAS ONE ENDEAVOR DRUG ELUTING STENT IMPLANTED IN THE 2ND LPL. IT IS REPORTED THAT APPROXIMATELY 31 MONTHS POST INDEX PROCEDURE, THE PATIENT EXPIRED. THE CAUSE OF DEATH WAS SUBARACHNOID HEMORRHAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114568 ENDEAVOR RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR Death ASPIRIN AND TICLOPIDINE