BEUDAMED
    FDA Adverse Event Death Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 3890682 · Received June 24, 2014

    Report

    Report Number
    9612164-2014-00670
    Event Type
    Death
    Date Received
    June 24, 2014
    Date of Event
    January 1, 2014
    Report Date
    May 26, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION, RESULTS: (ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED); INHERENT RISK OF PROCEDURE ¿ (DEATH, MI, STENT THROMBOSIS, HAEMORRHAGE); (NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED) - DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW; (NONE) ¿ DEVICE NOT RETURNED FOR EVALUATION. CONCLUSIONS: INHERENT RISK OF PROCEDURE ¿ (DEATH, MYOCARDIAL INFARCTION, STENT THROMBOSIS AND HAEMORRHAGE); UNKNOWN - (ROOT CAUSE COULD NOT BE DETERMINED). (B)(4).

    Description of Event or Problem · 1

    PATIENT HAD A RESOLUTE INTEGRITY DRUG ELUTING STENT IMPLANTED IN THE RCA WITH 95% STENOSIS. APPROXIMATELY 5 DAYS LATER THE PATIENT EXPIRED. CAUSE OF DEATH WAS REPORTED AS MIXED SHOCK (CARDIOGENIC AND HYPOVOLEMIC), ACUTE MYOCARDIAL INFARCTION WITH INFERIOR ST ELEVATION WITH RIGHT CORONARY ARTERY STENT THROMBOSIS AND UPPER GASTROINTESTINAL BLEEDING (CHRONIC PEPTIC ULCER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367700 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR Death DUAL ANTI-PLATELET THERAPY