BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 2340207 · Received November 17, 2011

    Report

    Report Number
    9612164-2011-01428
    Event Type
    Death
    Date Received
    November 17, 2011
    Date of Event
    October 16, 2011
    Report Date
    October 19, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS (B)(4) INHERENT RISK OF PROCEDURE (DEATH). (B)(4). 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

    DURING INDEX PROCEDURE THE PATIENT HAD THREE ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG-ELUTING STENTS IMPLANTED TO THE PROXIMAL RCA AND ONE ENDEAVOR SPRINT RX DRUG-ELUTING STENT IMPLANTED TO THE CIRCUMFLEX ARTERY AV GROOVE CONTINUATION SEGMENT. APPROXIMATELY THREE WEEKS POST INDEX PROCEDURE DURING A CHOLECYSTECTOMY PROCEDURE THE PATIENT SUFFERED A VENTRICULAR FIBRILLATION AND DIED. THE INVESTIGATOR INDICATED THAT THE REPORTED EVENT WAS UNRELATED TO THE STUDY DEVICE. (REF MFR # 9612164-2011-01427, 9612164-2011-01428, 9612164-2011-01429 AND 9612164-2011-01430)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0002877107

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Death BETA BLOCKER, DIGOXIN, DIURETIC AND ASA