BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 3772013 · Received April 25, 2014

    Report

    Report Number
    9612164-2014-00444
    Event Type
    Injury
    Date Received
    April 25, 2014
    Date of Event
    March 27, 2014
    Report Date
    March 29, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: (ROOT CAUSE UNDETERMINED). INHERENT RISK OF PROCEDURE (OCCLUSION). NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED (DEVICE OR PROCEDURAL IMAGES WERE NOT RETURNED FOR REVIEW). EVALUATION CONCLUSIONS: (ROOT CAUSE UNDETERMINED). INHERENT RISK OF PROCEDURE (OCCLUSION). UNABLE TO CONFIRM COMPLAINT (DEVICE OR PROCEDURAL IMAGES WERE NOT RETURNED FOR REVIEW). (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PHYSICIAN DEPLOYED A RESOLUTE INTEGRITY 2.50 X 14 MM DRUG ELUTING STENT SUCCESSFULLY IN A RCA LESION WITH 99% STENOSIS. THERE WERE NO PREVIOUS STENTS IN THE RCA VESSEL. THE STENT WAS POST-DILATED WITH A NON-MEDTRONIC BALLOON TWICE AND APPEARED TO BE WELL OPPOSED. AFTER 20 MINS HOWEVER, THERE APPEARED TO BE TISSUE INSIDE THE STENT, THE PHYSICIAN DESCRIBED THIS AS "PLAQUE PROLAPSE." ANOTHER UNKNOWN BALLOON WAS USED BUT THE TISSUE APPEARED AGAIN AFTER THIS DILATATION. NITRO WAS ADMINISTERED WITH NO RESOLUTION OCCURRING SO THE PHYSICIAN PLACED A NON-MEDTRONIC STENT INSIDE THE RESOLUTE STENT. PATIENT WAS DISCHARGED WITH NO ADDITIONAL COMPLICATIONS OR ADVERSE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250932 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0006909207

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR