BEUDAMED
    FDA Adverse Event Death Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 4890918 · Received July 6, 2015

    Report

    Report Number
    9612164-2015-01208
    Event Type
    Death
    Date Received
    July 6, 2015
    Date of Event
    December 7, 2013
    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

    EVALUATION CODES, RESULTS: INHERENT RISK OF PROCEDURE ¿ (CVA/STROKE,DEATH) EVALUATION CODES, CONCLUSIONS: INHERENT RISK OF PROCEDURE (B)(4).

    Additional Manufacturer Narrative · 1

    THE PATIENT HAD A HISTORY OF HYPERTENSION, HYPERLIPIDEMIA, DIABETES AND PREVIOUS PCI. INDEX PROCEDURE WAS PROMPTED BY STABLE ANGINA. DURING THE INDEX PROCEDURE THE 3 RSINT STENTS WERE IMPLANTED IN THE FOLLOWING VESSELS, 2 IN THE CX AND THE 3RD IN THE 2ND OM. DURING A STAGED PROCEDURE APPROX. 1 MONTH LATER ANOTHER 4 RESOLUTE INTEGRITY DRUG-ELUTING STENTS WERE IMPLANTED IN THE RCA. IT WAS ASSESSED THAT THE STROKE AND CARDIAC DEATH WERE NOT RELATED TO THE STUDY STENTS.

    Additional Manufacturer Narrative · 1

    CEC HAS ADJUDICATED THE PREVIOUSLY REPORTED DEATH WAS NOT RELATED TO THE STUDY DEVICE.

    Description of Event or Problem · 1

    THREE RESOLUTE INTEGRITY DRUG-ELUTING STENTS WERE IMPLANTED; ONE IN THE 2ND DIAGONAL, LCX AND 2ND OM DURING THE INDEX PROCEDURE. APPROXIMATELY 4 DAYS POST INDEX PROCEDURE PATIENT SUFFERED CEREBROVASCULAR DISORDER PATIENT WAS HOSPITALISED FOR TREATMENT. APPROXIMATELY 3 MONTHS POST INDEX PROCEDURE PATIENT EXPIRED. CAUSE OF DEATH WAS CARDIAC DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437400 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR Death| H