BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2170037 · Received July 15, 2011

    Report

    Report Number
    9612164-2011-00731
    Event Type
    Death
    Date Received
    July 15, 2011
    Date of Event
    March 31, 2011
    Report Date
    June 16, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): RESULTS - (DEATH, CORONARY). CONCLUSION - NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    THE PATIENT HAD ONE ENDEAVOR SPRINT STENT IMPLANTED IN THE MID LAD DURING THE INDEX PROCEDURE. AT 30 DAY/6 MONTH/1 YEAR/1.5 YEAR/2 YEAR FOLLOW UPS: PATIENT WAS ASYMPTOMATIC. AT THE 2.5 YEAR FOLLOW UP: PATIENT SUFFERED FROM SILENT ISCHEMIA. IT WAS REPORTED THAT SUDDEN DEATH OCCURRED 3 YEARS AND 4 MONTHS POST INDEX PROCEDURE. NO AUTOPSY REPORT WAS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death ASPIRIN