BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 4234127 · Received November 7, 2014

    Report

    Report Number
    9612164-2014-01436
    Event Type
    Malfunction
    Date Received
    November 7, 2014
    Date of Event
    October 8, 2014
    Report Date
    November 7, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: (ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED). INHERENT RISK OF PROCEDURE (FAILURE TO DELIVER STENT) CONCLUSION CODE RESULTS. KNOWN INHERENT RISK (FAILURE TO DELIVER STENT). (ROOT CAUSE COULD NOT BE DETERMINED). (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS: INHERENT RISK OF PROCEDURE (STENT FRACTURE). (NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED) - DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW. DEVICE NOT RETURNED FOR EVALUATION. CONCLUSION RESULTS: INHERENT RISK OF PROCEDURE ¿ (STENT FRACTURE). UNABLE TO CONFIRM COMPLAINT (DEVICE NOT RETURNED).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE REPORTING FACILITY CONFIRMED THAT THERE WAS NO DAMAGE TO THE STENT.

    Description of Event or Problem · 1

    A RESOLUTE INTEGRITY DRUG-ELUTING STENT WAS USED TO TREAT A LESION. IT IS REPORTED THAT WHEN THE STENT WAS TRYING TO CROSS THE LESION THE STENT WAS FRACTURED. THE DEVICE WAS REMOVED AND A SHORTER RESOLUTE INTEGRITY WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    718007 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0007220083

    Patients

    Seq Age Sex Outcome Treatment
    1