BEUDAMED
    FDA Adverse Event Death Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 4904866 · Received July 10, 2015

    Report

    Report Number
    9612164-2015-01243
    Event Type
    Death
    Date Received
    July 10, 2015
    Date of Event
    January 27, 2014
    Report Date
    October 6, 2015
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT HAD A HISTORY OF HYPERLIPIDEMIA AND PREVIOUS STROKE. INDEX PROCEDURE WAS PROMPTED BY STABLE ANGINA.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO RECEIVED: REPORTED THAT DURING INDEX PROCEDURE ANOTHER 2 RESOLUTE INTEGRITY DRUG-ELUTING STENTS WERE IMPLANTED, ONE IN THE LAD AND ONE IN THE 1ST DIAGONAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE PATIENT RECEIVED A RESOLUTE INTEGRITY (RX) DRUG ELUTING STENT TO TREAT A LESION IN THE PROXIMAL LAD. IT WAS REPORTED THAT 5 DAYS POST INDEX PROCEDURE THE PATIENT DIED AFTER BEING TAKEN TO HOSPITAL BY AMBULANCE. CEC ASSESSED THE EVENT AS CARDIAC DEATH BECAUSE IT WAS A SUDDEN DEATH OF UNKNOWN CAUSE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450359 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR Death