BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 1150169 · Received September 3, 2008

    Report

    Report Number
    2953200-2008-00756
    Event Type
    Death
    Date Received
    September 3, 2008
    Date of Event
    July 6, 2008
    Report Date
    August 4, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE LESION TREATED WAS THE PROXIMAL LAD. ONE ENDEAVOR SPRINT STENT WAS SUCCESSFULLY IMPLANTED. PT SUFFERED A NON-SUDDEN, CARDIAC DEATH 10 DAYS POST STENT IMPLANT. DEATH IS REPORTED TO BE ASSOCIATED WITH AN MI. AUTOPSY REPORT IS NOW AVAILABLE. INVESTIGATOR INDICATED THE PT DEATH WAS NOT RELATED TO THE ENDEAVOR SPRINT STENT. PLEASE NOTE THAT THIS DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA 0000546463

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death