BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESOLUTE INTEGRITY OTW

    MDR report key: 3012824 · Received March 20, 2013

    Report

    Report Number
    9612164-2013-00318
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    February 18, 2013
    Report Date
    February 19, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: STENT DISLODGEMENT/FAILURE TO DELIVER STENT. HIGHLY DISEASED VESSEL. DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW. CONCLUSION: STENT DISLODGEMENT/FAILURE TO DELIVER STENT. HIGHLY DISEASED VESSEL. DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW. (B)(4).

    Description of Event or Problem · 1

    FOUR RESOLUTE INTEGRITY DRUG ELUTING STENTS WERE IMPLANTED IN AN IMA GRAFT. THE ENTIRE VESSEL WAS DISEASED. HIGH RESISTANCE WAS FELT TRYING TO PLACE A 5TH STENT DISTAL TO THE 4TH. THE STENT CAME OFF THE BALLOON IN THE OSTIAL LESION. NO ABNORMALITY WAS NOTED DURING PREPARATION OF RESOLUTE DEVICE. INFORMATION PROVIDED CONFIRMS FORCE WAS USED DURING THE ATTEMPTED DELIVERY AND THE STENT GOT CAUGHT ON CALCIUM. THE STENT WAS NOT REMOVED AND THE PATIENT IS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114803 RESOLUTE INTEGRITY OTW STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1