BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR RX CORONARY STENT SYSTEM

    MDR report key: 1062219 · Received June 18, 2008

    Report

    Report Number
    2953200-2008-00435
    Event Type
    Death
    Date Received
    June 18, 2008
    Date of Event
    September 16, 2007
    Report Date
    May 22, 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
    LG
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL RESULTS: DEATH. LACK OF INFO, NO AUTOPSY REPORT. CONCLUSIONS LACK OF INFO, NO AUTOPSY REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS TREATED 18 DAYS POST MYOCARDIAL INFARCTION WITH TWO ENDEAVOR STENTS. THE TWO LESIONS WERE THE OSTIAL LAD (2.75 MM X 12 MM) (MFR REPORT# 2953200-2008-00436) AND THE SECOND LESION PROXIMAL LAD (2.75 MM X 14 MM) THE STENTS WERE SUCCESSFULLY DEPLOYED. THE PT WAS DISCHARGED THE DAY FOLLOWING STENT PLACEMENT PROCEDURE. THE PT RETURNED FOR F/U 30 DAYS WHICH WAS SUCCESSFUL AND THE INVESTIGATOR PRESCRIBED ASPIRIN AND CLOPIDOGREL. AT THE 6 MO F/U WHICH WAS SUCCESSFUL THE INVESTIGATOR PRESCRIBED ASPIRIN AND CLOPIDOGREL. AT THE 12 MO F/U WHICH WAS ALSO SUCCESSFUL THE INVESTIGATOR PRESCRIBED ASPIRIN. IT WAS REPORTED THAT THE PT EXPIRED 19 MOS POST STENT IMPLANT. CAUSE OF DEATH IS UNK AND NO AUTOPSY AVAILABLE. 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 RX CORONARY STENT SYSTEM NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death CLOPIDOGREL 75 MG DAY OF PROCEDURE| ASPIRIN 100MG DAY OF PROCEDURE