BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 3850249 · Received June 5, 2014

    Report

    Report Number
    9612164-2014-00558
    Event Type
    Death
    Date Received
    June 5, 2014
    Date of Event
    July 27, 2013
    Report Date
    May 30, 2014
    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, CONCLUSIONS: INHERENT RISK OF PROCEDURE. (B)(4).

    Description of Event or Problem · 1

    DURING INDEX PROCEDURE, THE PHYSICIAN IMPLANTED TWO ENDEAVOR SPRINT DRUG ELUTING STENTS IN THE 1ST DIAGONAL. IT IS REPORTED THAT APPROXIMATELY 22 MONTHS POST INDEX PROCEDURE, THE PATIENT EXPIRED. CAUSE OF DEATH IS REPORTED AS THROMBUS PULMONARY EMBOLISM. INVESTIGATOR ASSESSED THE EVENT TO BE UNRELATED TO THE STUDY DEVICE AND STUDY PROCEDURE. CEC ADJUDICATED THAT THE DEATH WAS CARDIAC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329577 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0005417489

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Death