BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 7368539 · Received March 24, 2018

    Report

    Report Number
    9612164-2018-00553
    Event Type
    Injury
    Date Received
    March 24, 2018
    Date of Event
    October 1, 2017
    Report Date
    March 24, 2018
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE ABSTRACT (ONLY) AVAILABLE - NO FURTHER DETAILS AVAILABLE KHAN F., MARCINIAK M. J. INVASIVE CARDIOL. 2017 29:10 (E143) EMBASE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PROCEDURE WAS PROMPTED BY ST ELEVATION. ANGIO REVEALED AN OCCLUDED RCA. A BMW WIRE WAS ADVANCED TO THE DISTAL VESSEL AND AN ASPIRATION CATHETER RUN RESTORED TIMI 3 FLOW REVEALING CRITICAL AND SEVERE LESIONS IN THE RCA. TWO RESOLUTE INTEGRITY STENTS WERE IMPLANTED IN THE RCA. ANGIO POST IMPLANTATION REVEALED A PERFORATION AT THE SITE OF THE SECOND IMPLANTED STENT. TWO NON-MDT STENTS WERE DEPLOYED TO TREAT THE PERFORATION WITH GOOD RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211426 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention