BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK CARDIO SEAL

    MDR report key: 1011865 · Received March 7, 2008

    Report

    Report Number
    1222632-2008-00004
    Event Type
    Injury
    Date Received
    March 7, 2008
    Date of Event
    January 21, 2008
    Report Date
    March 7, 2008
    Manufacturer
    NMT MEDICAL, INC.
    Product Code
    MLV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE IMPLANT LOT # WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. WE HAVE NO ADD'L INFO SURROUNDING THIS CASE AT THE MOMENT. WE HAVE INITIATED CONTACT WITH THE END-USER AND SUBMITTED A REQUEST FOR THE ER/OR CASE SUMMARIES AS WELL AS REQUESTED TO HAVE THE IMPLANT RETURNED FOR EVAL. NONE OF THE REQUESTED INFO, OR THE IMPLANT WAS REC'D AS YET. WE WILL CONTINUE TO PURSUE THE REQUESTED INFO. UPON RECEIPT WE WILL CONDUCT A THOROUGH INVESTIGATION AND SUBMIT A SUMMARY OF OUR FINDINGS IN A F/U REPORT.

    Description of Event or Problem · 1

    THE END-USER REPORTED A MALE PT UNDERWENT SUCCESSFUL PFO CLOSURE IN 2007, WITHOUT COMPLICATIONS. PT WAS ASYMPTOMATIC UNTIL 2008, WHEN HE PRESENTED IN THE EMERGENCY DEPT WITH SIGNS OF CARDIAC TAMPONADE. THE PT WAS IMMEDIATELY TAKEN FOR SURGERY, WHERE IT WAS DISCOVERED, ONE ARM OF THE IMPLANT HAD ERODED THROUGH THE DOME OF THE LEFT ATRIUM, BENEATH THE PULMONARY ARTERY, AND BENEATH THE ASCENDING AORTA. THE PT SURVIVED AND IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK CARDIO SEAL OCCLUDER MLV NMT MEDICAL, INC. UNK CARDIOSEAL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Life Threatening| R