BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR RX CORONARY STENT SYSTEM

    MDR report key: 1666444 · Received April 22, 2010

    Report

    Report Number
    2953200-2010-00688
    Event Type
    Death
    Date Received
    April 22, 2010
    Date of Event
    July 22, 2009
    Report Date
    March 23, 2010
    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
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE PATIENT'S CARDIAC STATUS AT TIME OF THE INDEX PROCEDURE WAS ACUTE CORONARY SYNDROME. THE PATIENT HAD 1 ENDEAVOR SPRINT RX DRUG-ELUTING STENT IMPLANTED TO THE PROX LEFT ANTERIOR DESCENDING. THE PATIENT WAS ASYMPTOMATIC AT 30 DAY, 6 MONTH, 1 YEAR AND 1.5 YEAR FOLLOW UP. APPROXIMATELY 2 YEARS POST INDEX PROCEDURE, THE PATIENT SUFFERED A NON SUDDEN CARDIAC DEATH. CAUSE OF DEATH WAS PROVIDED AS WORSENING OF LEFT & RIGHT VENTRICLE FUNCTION AND REFRACTING HEART FAILURE. THE INVESTIGATOR INDICATED THAT THE EVENT WAS RELATED TO THE STUDY DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR RX CORONARY STENT SYSTEM NIQ MEDTRONIC CARDIO VASCULAR GALWAY NA 0000470546

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death CLOPIDOGREL - PRIOR TO THE REPORTED EVENT| ASPIRIN - PRIOR TO THE REPORTED EVENT