BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 4780749 · Received May 19, 2015

    Report

    Report Number
    9612164-2015-00711
    Event Type
    Malfunction
    Date Received
    May 19, 2015
    Date of Event
    April 6, 2015
    Report Date
    April 20, 2015
    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: INHERENT RISK OF PROCEDURE (STENT DEFORMATION). (NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED) - DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW. RELATED TO OPERATIONAL CONTEXT (INTERACTION WITH GUIDE CATHETER CAUSED THE DEFORMATION). DEVICE NOT RETURNED FOR EVALUATION. EVALUATION CONCLUSION: KNOWN INHERENT RISK (STENT DEFORMATION). UNABLE TO CONFIRM COMPLAINT (DEVICE NOT RETURNED). RELATED TO OPERATIONAL CONTEXT (INTERACTION WITH GUIDE CATHETER CAUSED THE DEFORMATION). DEVICE NOT RETURNED -NO EVALUATION WILL BE PERFORMED. (B)(4).

    Description of Event or Problem · 1

    PHYSICIAN WAS ATTEMPTING TO IMPLANT ONE RESOLUTE INTEGRITY DRUG-ELUTING STENT TO A CALCIFIED AND TORTUOUS LESION IN THE LCX BUT IT FAILED TO CROSS THE LESION AND WHEN IT WAS REMOVED STENT STRUTS WHERE NOTED TO BE DEFORMED. PHYSICIAN USED ANOTHER RESOLUTE INTEGRITY OF THE SAME SIZE TO COMPLETE THE PROCEDURE. THE PHYSICIAN SAID THE STENT STRUT GOT CAUGHT ON THE GUIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326413 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0007463158

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR