BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 1062218 · Received June 18, 2008

    Report

    Report Number
    2953200-2008-00433
    Event Type
    Death
    Date Received
    June 18, 2008
    Date of Event
    May 10, 2008
    Report Date
    May 21, 2008
    Manufacturer
    MEDTRONIC CARDIO VASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL RESULTS: DEATH AND MYOCARDIUM INFARCTION. LACK OF INFO. CONCLUSIONS: LACK OF INFO.

    Description of Event or Problem · 1

    THE PT'S CARDIAC STATUS AT THE TIME OF THE PROCEDURE WAS STABLE ANGINA. IT WAS REPORTED THAT ONE ENDEAVOR SPRINT STENT WAS SUCCESSFULLY IMPLANTED (2.75X24MM) IN PROXIMAL LAD. IT WAS REPORTED FOUR DAYS LATER THE PT SUFFERED AN ACUTE STEMI. THE PT WAS ADMITTED TO ANOTHER HOSP WITH AN ANTERIOR MI WHICH LED TO A VF ARREST FROM WHICH THE SUBJECT COULD NOT BE RESUSCITATED. THAT SAME DAY THE PT SUFFERED A NON-SUDDEN CARDIAC DEATH. THE INVESTIGATOR ASSESSED THE EVENT AS A Q-WAVE MI & THAT THE EVENT WAS UNRELATED TO THE PROCEDURE. AUTOPSY REPORT IS NOT AVAILABLE. PLEASE NOTE THAT THIS DEVICE IS NOT DISTRIBUTED IN THE UNTIED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX NIQ MEDTRONIC CARDIO VASCULAR GALWAY NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death