BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 2914841 · Received January 15, 2013

    Report

    Report Number
    9612164-2013-00066
    Event Type
    Death
    Date Received
    January 15, 2013
    Date of Event
    December 31, 2011
    Report Date
    January 4, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PATIENT DIED DUE TO RESPIRATORY FAILURE.IT IS REPORTED THAT APPROXIMATELY 27 MONTHS POST INDEX PROCEDURE THE PATIENT HAD A TARGET VE SSEL REVASCULARIZATION OF THE LAD USING A NON MEDTRONIC STENT. ON THAT DAY THERE WAS ALSO A NON TARGET REVASCULARIZATION OF THE RCA USING A NON MEDTRONIC STENT. THE INVESTIGATOR HAS ASSESSED THAT THE EVENT WAS NOT RELATED TO THE DEVICE. THE PATIENT RECOVERED WITH TREATMENT.

    Description of Event or Problem · 1

    DURING THE INDEX PROCEDURE TWO ENDEAVOR SPRINT DRUG-ELUTING STENTS WERE IMPLANTED IN THE LAD. APPROXIMATELY 33 MONTHS POST THE INDEX PROCEDURE, THE PATIENT EXPIRED. THE CAUSE OF DEATH WAS ASSESSED AS DUE TO HEART FAILURE. THE INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22155 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

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