BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 3792227 · Received May 6, 2014

    Report

    Report Number
    9612164-2014-00496
    Event Type
    Death
    Date Received
    May 6, 2014
    Date of Event
    November 3, 2013
    Report Date
    April 25, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION, RESULTS, CONCLUSIONS: INHERENT RISK OF PROCEDURE ¿ (DEATH, MYOCARDIAL INFARCTION). (B)(4).

    Description of Event or Problem · 1

    DURING INDEX PROCEDURE, THE PATIENT HAD THE ONE ENDEAVOR SPRINT DRUG ELUTING STENT IMPLANTED IN THE RCA. APPROXIMATELY 42.5 MONTHS POST INDEX PROCEDURE, THE PATIENT SUFFERED AN MI DUE TO STENOSIS OF THE LAD AND AN UNKNOWN BRAND STENT WAS IMPLANTED AS TREATMENT. FIVE DAYS POST REVASCULARIZATION, PATIENT DEATH OCCURRED. CAUSE OF DEATH WAS CONFIRMED AS MI AND MULTIPLE ORGAN FAILURE. INVESTIGATOR INDICATED THAT THE REPORTED EVENTS WERE NOT RELATED TO THE STUDY DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272517 ENDEAVOR SPRINT RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Death| R