BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 2913067 · Received January 14, 2013

    Report

    Report Number
    9612164-2013-00061
    Event Type
    Death
    Date Received
    January 14, 2013
    Date of Event
    April 27, 2011
    Report Date
    April 2, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CLINICAL EVENTS COMMITTEE ADJUDICATED THAT THE PREVIOUSLY REPORTED MI WAS CONSISTENT WITH AN ARC MI AND OCCURRED ONE DAY PRIOR TO THE PREVIOUSLY REPORTED DATE. IT IS REPORTED THAT OTHER SIGNIFICANT CONDITIONS CONTRIBUTING TO PATIENT DEATH WERE ACUTE RENAL FAILURE, RESPIRATORY FAILURE, DIABETES MELLITUS AND HYPERTENSION.

    Description of Event or Problem · 1

    DURING INDEX PROCEDURE, THREE ENDEAVOR SPRINT DRUG ELUTING STENTS WERE IMPLANTED; ONE IN THE LCX, ONE IN THE 1ST OBTUSE MARGINAL AND ONE IN THE RCA. APPROXIMATELY 3 MONTHS POST INDEX PROCEDURE, THE PATIENT SUFFERED AN MI. INVESTIGATOR INDICATED THAT THE EVENT WAS NOT RELATED TO THE DEVICE. IT IS REPORTED THAT THE PATIENT RECOVERED WITH TREATMENT. APPROXIMATELY 7 MONTHS POST INDEX PROCEDURE, IT IS REPORTED THAT THE PATIENT EXPIRED. THE CAUSE OF DEATH WAS CONGESTIVE HEART FAILURE. INVESTIGATOR HAS ASSESSED THAT THE EVENT WAS NOT RELATED TO THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20798 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Death ASPIRIN AND CLOPIDOPGREL