BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 2850438 · Received November 29, 2012

    Report

    Report Number
    9612164-2012-01714
    Event Type
    Death
    Date Received
    November 29, 2012
    Date of Event
    November 1, 2012
    Report Date
    March 14, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVALUATION, RESULTS: INHERENT RISK OF PROCEDURE (DEATH). (B)(4).

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: DATE YEAR ONLY VALID. (B)(4). EVALUATION CODE, RESULTS: INHERENT RISK OF PROCEDURE (STROKE).

    Description of Event or Problem · 1

    PATIENT DEATH WAS ASSESSED TO BE A CARDIAC DEATH.

    Description of Event or Problem · 1

    DURING INDEX PROCEDURE THE PATIENT HAD ONE ENDEAVOR SPRINT RX STENT IMPLANTED IN THE RCA. APPROXIMATELY ONE MONTH POST INDEX PROCEDURE, THE PATIENT HAD A STAGED PROCEDURE WHERE TWO ENDEAVOR SPRINT RX STENTS WERE IMPLANTED IN THE CX. APPROXIMATELY 12 MONTHS POST INDEX PROCEDURE THE PATIENT SUFFERED A STROKE. APPROXIMATELY 15 DAYS LATER, THE PATIENT EXPIRED. DEATH IS REPORTED AS NON-CARDIAC, CAUSE UNKNOWN. IT HAS BEEN ASSESSED THAT THE DEATH WAS NOT RELATED TO THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0005479133

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Death| H ASPIRIN AND CLOPIDOGREL