BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 1760792 · Received July 15, 2010

    Report

    Report Number
    2953200-2010-01334
    Event Type
    Death
    Date Received
    July 15, 2010
    Date of Event
    June 14, 2010
    Report Date
    June 16, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4): EVALUATION RESULTS: (ROOT CAUSE CANNOT BE DETERMINED), (DEATH).

    Description of Event or Problem · 1

    A 3.0MM DIAMETER X 15MM LENGTH ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG ELUTING CORONARY STENT WAS DEPLOYED IN A PATIENT WITH NO ISSUE REPORTED; HOWEVER, IT WAS REPORTED THAT APPROXIMATELY 3 WEEKS POST IMPLANT, VENTRICULAR FIBRILLATION (VF) WAS CONFIRMED. THE PATIENT WAS TRANSPORTED TO HOSPITAL, CARDIOPULMONARY RESUSCITATION WAS PERFORMED; HOWEVER, THE PATIENT DIED. THE PHYSICIAN CONFIRMED THAT THE CAUSE OF DEATH WAS VF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA 0001530125

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death MAINTATE| CRESTOR| TANATRIL| CARDENALIN| BEZATOL| AMARYL| LASIX| TAKEPRON| ASPIRIN| LONGES| ACTOS| CLOPIDOGREL| MEDET| ALDACTONE-A| CALBLOCK