BEUDAMED
    FDA Adverse Event Death Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 6078749 · Received November 4, 2016

    Report

    Report Number
    9612164-2016-01152
    Event Type
    Death
    Date Received
    November 4, 2016
    Date of Event
    December 26, 2014
    Report Date
    October 13, 2016
    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

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    DURING INDEX PROCEDURE THE PATIENT HAD TWO RESOLUTE INTEGRITY DRUG-ELUTING STENTS IMPLANTED IN THE LAD. APPROXIMATELY 8 MONTHS POST INDEX PROCEDURE PATIENT DEATH OCCURRED. IT WAS REPORTED THAT CT WAS CONDUCTED AFTER THE DEATH AT ANOTHER HOSPITAL, AND IT SHOWED PULMONARY EDEMA. THE PATIENT'S DEATH WAS DECIDED AS CARDIAC DEATH. INVESTIGATOR INDICATED THE REPORTED EVENT WAS NOT RELATED TO STUDY DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729752 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death