BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 2820086 · Received November 6, 2012

    Report

    Report Number
    9612164-2012-01623
    Event Type
    Death
    Date Received
    November 6, 2012
    Date of Event
    October 7, 2012
    Report Date
    April 23, 2013
    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

    RESULTS: INHERENT RISK OF PROCEDURE (MI, DEATH). (B)(4). DATE OF DEATH- MONTH AND YEAR VALID ONLY.

    Description of Event or Problem · 1

    THE PATIENT HAD TWO ENDEAVOR SPRINT DRUG-ELUTING STENTS IMPLANTED IN THE LAD DURING THE INDEX PROCEDURE. IT WAS REPORTED THAT APPROXIMATELY 18 MONTHS POST THE INDEX PROCEDURE THE PATIENT SUFFERED A CARDIAC DEATH. CAUSE OF DEATH WAS HEART ATTACK (MI). THE INVESTIGATOR HAS INDICATED THAT THE EVENT WAS NOT RELATED TO THE STUDY STENT.

    Description of Event or Problem · 1

    MI EVENT OCCURRED 3 DAYS PRIOR TO PATIENT DEATH.

    Description of Event or Problem · 1

    DATE OF DEATH CONFIRMED. PREVIOUSLY REPORTED MI OCCURRED ON THE SAME DATE AS PATIENT DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0003134626

    Patients

    Seq Age Sex Outcome Treatment
    1 00086 YR Death ASPIRIN AND CLOPIDOGREL.