BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTE INTEGRITY RX DES

    MDR report key: 5048837 · Received September 2, 2015

    Report

    Report Number
    5048837
    Event Type
    Malfunction
    Date Received
    September 2, 2015
    Date of Event
    July 14, 2015
    Report Date
    July 21, 2015
    Manufacturer
    MEDTRONIC VASCULAR
    Product Code
    NIQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    STENT CATHETER WAS INTRODUCED INTO PATIENT'S BODY FOR DEPLOYMENT. IT WAS UNABLE TO BE PASSED ACROSS THE STENOSED AREA AND WAS TO BE REMOVED UNDEPLOYED. WHILE REMOVING THE STENT CATHETER, THE WIRE ALSO PULLED BACK OUT OF THE VESSEL AND INTO THE CATHETER. WHEN REMOVED FROM THE BODY, NO STENT WAS OBSERVED ON THE CATHETER. THE STENT WAS LOCATED IN THE PATIENT'S VESSEL. ATTEMPTS TO REMOVE THE STENT WERE UNSUCCESSFUL AND IT PASSED INTO THE PATIENT'S GLUTEAL ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581021 RESOLUTE INTEGRITY RX DES CORONARY DRUG-ELUTING STENT NIQ MEDTRONIC VASCULAR 0007152350

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR NO