BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 2331559 · Received November 10, 2011

    Report

    Report Number
    9612164-2011-01398
    Event Type
    Death
    Date Received
    November 10, 2011
    Date of Event
    April 14, 2011
    Report Date
    October 14, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: (B)(4) INHERENT RISK OF PROCEDURE (THROMBUS, DEATH). MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT.

    Description of Event or Problem · 1

    AN ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG ELUTING STENT WAS IMPLANTED IN THE PROXIMAL LAD DURING INDEX PROCEDURE. IT IS REPORTED THAT THE PATIENT SUFFERED A STENT THROMBOSIS AND EXPIRED APPROXIMATELY 8 MONTHS POST INDEX PROCEDURE. THE CAUSE OF DEATH WAS REPORTED AS ACUTE CORONARY ARTERY THROMBOSIS DUE TO ATHEROSCLEROTIC CARDIOVASCULAR DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0002052044

    Patients

    Seq Age Sex Outcome Treatment
    1 Death