BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 2900732 · Received January 8, 2013

    Report

    Report Number
    9612164-2013-00034
    Event Type
    Death
    Date Received
    January 8, 2013
    Date of Event
    August 11, 2011
    Report Date
    December 18, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: DEATH.

    Description of Event or Problem · 1

    DURING INDEX PROCEDURE THE PATIENT HAD FIVE ENDEAVOR SPRINT DRUG ELUTING STENTS IMPLANTED - TWO IN THE LAD, ONE IN THE 1ST DIAGONAL BRANCH, ONE IN THE 1ST OBTUSE MARGINAL AND ONE IN THE RCA. DURING IMPLANTATION OF THE FIRST STENT IN THE LAD A DISSECTION OCCURRED WHICH WAS TREATED WITH AN ENDEAVOR SPRINT STENT. APPROXIMATELY 36.5 MONTHS POST INDEX PROCEDURE THE PATIENT EXPIRED. THE CAUSE OF DEATH WAS REPORTED TO BE CARDIAC, NON-SUDDEN DEATH. INVESTIGATOR INDICATED THAT IT IS NOT ASSESSABLE IF THE EVENT WAS RELATED TO THE STUDY STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9771 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0000698222

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Death ASPIRIN