BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRESSUREWIRE AERIS

    MDR report key: 3022653 · Received March 21, 2013

    Report

    Report Number
    8030904-2013-00005
    Event Type
    Injury
    Date Received
    March 21, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 8, 2013
    Manufacturer
    ST. JUDE MEDICAL SYSTEMS, AB
    Product Code
    DQX
    PMA / PMN Number
    K113584
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE DEVICE WAS MANUFACTURED ACCORDING TO SJM SPECIFICATION. THERE WAS NO INDICATION THE REPORTED EVENT WAS DUE TO A DEVICE MALFUNCTION OR ANY DEFICIENCY WITH THE INSTRUCTIONS FOR USE REQUIRING CORRECTIVE ACTION. WE WILL CONTINUE TO CLOSELY MONITOR THE PERFORMANCE OF THIS PRODUCT FOR ANY SIGNIFICANT TRENDS.

    Description of Event or Problem · 1

    A WIRE WAS INSERTED INTO THE RIGHT CORONARY ARTERY (RCA) WITH AN AERIS FFR WIRE. FOLLOWING FFR THE WIRE WAS REMOVED AND POST-FFR SHOWED A DISSECTION IN THE RCA. A BALLOON PUMP AND FOUR STENTS WERE REQUIRED TO REPAIR THE DISSECTION. THE PATIENT WAS TRANSPORTED TO ANOTHER FACILITY FOR OBSERVATION AND WAS DISCHARGED 3 DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118700 PRESSUREWIRE AERIS GUIDEWIRE SENSOR DQX ST. JUDE MEDICAL SYSTEMS, AB C12058 124792

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention