BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 5165415 · Received October 21, 2015

    Report

    Report Number
    9612164-2015-01674
    Event Type
    Injury
    Date Received
    October 21, 2015
    Date of Event
    November 13, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    DURING INDEX PROCEDURE, THE PATIENT HAD 3 RESOLUTE INTEGRITY DRUG-ELUTING STENTS IMPLANTED IN THE LCX, LPL AND LPD. APPROXIMATELY 12.5 MONTHS POST INDEX PROCEDURE, THE PATIENT HAD OCCLUSION OF THE LPL WHICH WAS TREATED APPROXIMATELY 3 WEEKS LATER WITH TVR OF THE LCX. INVESTIGATOR HAS INDICATED THAT THE TVR IS NOT RELATED TO THE STUDY DEVICE. STENT THROMBOSIS WAS CONFIRMED ON THE SAME DAY AS THE OCCLUSION. THROMBOSIS IS NOT RELATED TO THE STUDY DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694538 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Required Intervention ASPIRIN