BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK CARDIOSEAL

    MDR report key: 441713 · Received February 8, 2003

    Report

    Report Number
    1222632-2003-00004
    Event Type
    Injury
    Date Received
    February 8, 2003
    Date of Event
    January 7, 2003
    Report Date
    February 6, 2003
    Manufacturer
    NMT MEDICAL, INC.
    Product Code
    MLV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A PT WITH SEVERAL EPISODES OF VISUAL CHANGES AND CONFUSION FROM TIAS AND CVAS OVER THE PAST SEVERAL YEARS SECONDARY TO A "PFO" AND ATRIAL SEPTAL DEFECT RECEIVED A CARDIOSEAL SEPTAL OCCLUDER IN 2001. THE PT'S PAST MEDICAL HISTORY INCLUDES RECURRENT TIAS TIMES 10 PLUS YEARS AND MIGRAINES TIMES 10 YEARS. THE "PFO" WAS CHARACTERIZED AS A LONG TUNNEL "PFO" (15 TO 17 MM) AND WAS CLOSED VIA A TRANSSEPTAL APPROACH. POST "PFO" CLOSURE THE PT WAS PLACED ON ASA 82 MG Q.D. AND PLAVIX 75 MG Q.D. TIMES ONE MONTH AS WELL AS TOPROL XL 25 MG Q.D., VERAPAMIL 180 MG. Q.D. TIME ONE YEAR AND TOPOMAX 60 MG. P.P. Q.D. TIMES 2 MONTHS. THE PT PRESENTED IN 2003 REPORTING TWO EPISODES WHICH THE PT CHARACTERIZED AS "STROKES", IN 2002 THE PT DID HAVE A SUDDEN ONSET OF RIGHT HEMIANOPSIA WITH RESIDUAL RIGHT EYE VISUAL LOSS CONTINUING THROUGH 2003. THE PT ALSO REPORTED AN EPISODE OF DIZZINESS, WHICH WAS TRANSIENT, INCREASED SHORTNESS OF BREATH AND PALPITATIONS APPROXIMATELY 2 TIMES PER DAY. AN ECHOCARDIOGRAM REVEALED A CLOT IN THE LA ADHERENT TO THE CARDIOSEAL SEPTAL OCCLUDER. THE PT WAS PLACED ON IV HEPARIN FOR ANTICOAGULATION AND WHEN THEIR PTT WAS >60 PT WAS STARTED ON COUMADIN 10 MG. Q.H.S. A FOLLOW UP ECHOCARDIOGRAM 3 DAYS LATER REVEALED NO CLOT AND THE PT WAS DISCHARGED. DISCHARGE MEDICATIONS ASA 81 MG Q..D., PLAVIX 75 MG Q.D. TIMES 6 MONTHS, COUMADIN 5 MG Q.D. ALTERNATING WITH 2.5. MG Q.D., LOVENOX 60 MG SUBCU B.I.D. TIMES 3 DAYS, TOPROL XL 25 MG. Q.D., TOPOMAX 60 MG. Q.D. FOLLOW UP CLINIC VISITS WERE TO BE SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK CARDIOSEAL UNK CARDIOSEAL MLV NMT MEDICAL, INC. CS-33-QL-PFO 0212003

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other| R