BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2211876 · Received August 10, 2011

    Report

    Report Number
    9612164-2011-00884
    Event Type
    Death
    Date Received
    August 10, 2011
    Date of Event
    March 17, 2011
    Report Date
    July 12, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: (DEATH).

    Description of Event or Problem · 1

    AN ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG ELUTING STENT WAS IMPLANTED IN THE PROXIMAL LAD DURING INDEX PROCEDURE. PT WAS ASYMPTOMATIC / FREE OF SYMPTOMS AT 30 DAY, 6 MONTH, 1 YEAR, 1.5 YEAR, 2 YEAR AND 2.5 YEAR FOLLOW UPS. AT 3 YEAR FOLLOW-UP PTS WORST ANGINA STATUS WAS SILENT ISCHEMIA. IT IS REPORTED THAT THE PT EXPIRED APPROXIMATELY 3 YEARS AND 4 MONTHS POST INDEX PROCEDURE. IT IS REPORTED THAT THE PT DEATH WAS A NON-SUDDEN CARDIAC DEATH. THE CAUSE OF DEATH IS REPORTED AS HEART FAILURE. THE AUTOPSY REPORTED GENERAL ARTERIOSCLEROSIS, CORONARY ARTERY DISEASE, MULTIPLE MYOCARDIAL INFRACTIONS AND PULMONARY EDEMA. INVESTIGATOR HAS INDICATED THAT THE EVENT WAS NOT RELATED TO THE STUDY STENT OR THE STUDY PROCEDURE. IT WAS REPORTED THAT THERE WAS NO EVIDENCE OF STENT THROMBOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC IRELAND NA 0000499824

    Patients

    Seq Age Sex Outcome Treatment
    1 Death