BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COVERED MOUNTED CP STENT

    MDR report key: 14110779 · Received April 14, 2022

    Report

    Report Number
    1318694-2022-00005
    Event Type
    Injury
    Date Received
    April 14, 2022
    Date of Event
    December 1, 2021
    Report Date
    April 14, 2022
    Manufacturer
    NUMED, INC.
    Product Code
    PNF
    PMA / PMN Number
    P150028
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE WAS NOT RETURNED TO NUMED FOR EVALUATION. THE PRODUCTION TRAVELER (DHR) WAS REVIEWED AND NO ISSUES WERE FOUND. ALL DEVICES IN THIS LOT MET THE CRITERIA FOR RELEASE AND DISTRIBUTION. THERE ARE NO OTHER ASSOCIATED COMPLAINTS WITH THIS LOT OF DEVICES. AS PER THE REPORT FROM THE FOREIGN DISTRIBUTOR, THE STENT DISLODGEMENT WAS MOST LIKELY CAUSED DUE TO THE CALCIUM IN THE PULMONARY VALVE. THEY BELIEVE THAT THE STENT CAUGHT ON THAT CALCIUM AND DISLODGED FROM THE BALLOON CATHETER IT WAS MOUNTED ON.

    Description of Event or Problem · 0

    AS REPORTED BY THE FOREIGN DISTRIBUTOR / USER FACILITY - CP STENT DISLODGED FROM BALLOON PRIOR TO VALVE REPLACEMENT. IT WAS SUCCESSFULLY SNARED. THE STENT WAS MOST LIKELY CAUGHT IN THE CALCIUM IN THE PULMONARY VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190704 COVERED MOUNTED CP STENT AORTIC STENT PNF NUMED, INC. 428 CMCP-3389

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female Required Intervention