BEUDAMED
    FDA Adverse Event Death Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 2874998 · Received December 17, 2012

    Report

    Report Number
    9612164-2012-01781
    Event Type
    Death
    Date Received
    December 17, 2012
    Date of Event
    November 18, 2012
    Report Date
    January 17, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF DEATH CHANGED FROM 4 DAYS POST IMPLANT OF MEDTRONIC STENTS TO 5 DAYS POST IMPLANT.

    Additional Manufacturer Narrative · 1

    RESULTS: INHERENT RISK OF PROCEDURE (DEATH, OCCLUSION); DEVICE OR IMAGES NOT RETURNED FOR EVALUATION. CONCLUSIONS: INHERENT RISK OF PROCEDURE (DEATH, OCCLUSION). (B)(4).

    Description of Event or Problem · 1

    PCI WAS PERFORMED ON PATIENT WITH AMI; PHYSICIAN DEPLOYED ONE NON-MEDTRONIC STENT TO RCA. APPROXIMATELY ONE WEEK LATER PHYSICIAN SUCCESSFULLY DEPLOYED 2 RESOLUTE INTEGRITY DRUG-ELUTING STENTS TO LAD DURING A PLANNED PCI. APPROXIMATELY 4 DAYS LATER PATIENT SUFFERED CARDIOPULMONARY ARREST, CAG SHOWED OCCLUSION IN LAD. ASPIRATION WAS PERFORMED ON THE PATIENT, BUT THEY EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0006203170

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 YR Death CLOPIDOGREL AND ASPIRIN.