BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 2973444 · Received February 22, 2013

    Report

    Report Number
    9612164-2013-00196
    Event Type
    Injury
    Date Received
    February 22, 2013
    Date of Event
    January 9, 2013
    Report Date
    January 25, 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

    RESULTS: BROKEN BONE NEEDED SURGERY WHICH REQUIRED DAPT CESSATION. THIS HAS RESULTED IN THE STENT THROMBOSIS. DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW. CONCLUSIONS: BROKEN BONE NEEDED SURGERY WHICH REQUIRED DAPT CESSATION. THIS HAS RESULTED IN THE STENT THROMBOSIS. (B)(4).

    Description of Event or Problem · 1

    DURING INDEX PROCEDURE THE PATIENT HAD TWO RESOLUTE INTEGRITY DRUG-ELUTING STENT SUCCESSFULLY DEPLOYED AT A MODERATELY CALCIFIED AND TORTUOUS LESION WITH 90% STENOSIS AT THE LAD. PATIENT WAS TAKING OFF DAPT DUE TO BROKEN BONE AFTER INITIAL PCI WHICH CAUSED STENT THROMBOSIS APPROXIMATELY 28 DAYS POST INDEX PROCEDURE. THE STENT THROMBOSIS WAS TREATED WITH PCI. NO CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77892 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR Required Intervention