BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR RX

    MDR report key: 1230174 · Received November 13, 2008

    Report

    Report Number
    2953200-2008-01047
    Event Type
    Death
    Date Received
    November 13, 2008
    Date of Event
    October 14, 2008
    Report Date
    October 16, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION CODES, RESULTS: (DEATH).

    Description of Event or Problem · 1

    THREE ENDEAVOR DRUG-ELUTING STENTS (REF. MFR REPORT #'S 2953200-2008-01048 AND 2953200-2008-01049) WERE IMPLANTED IN A PT FOR TREATMENT OF A CORONARY LESION. SIXTY MONTHS POST STENT IMPLANT, THE PT WAS HOSPITALIZED DUE TO ANGINA. CORONARY ANGIOGRAPHY WAS PERFORMED WITH NO PCI. THE PT EXPIRED THE FOLLOWING DAY DUE TO PERICARDIAL TAMPONADE. INVESTIGATOR HAS INDICATED THAT EVENT WAS UNRELATED TO THE STUDY STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR RX NIQ MEDTRONIC CARDIOVASCULAR SANTA ROSA NA 52067

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H