BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARDIOSEAL CS-23-QL-PFO

    MDR report key: 514224 · Received March 2, 2004

    Report

    Report Number
    1222632-2004-00002
    Event Type
    Death
    Date Received
    March 2, 2004
    Date of Event
    November 20, 2003
    Report Date
    March 2, 2004
    Manufacturer
    NMT MEDICAL, INC.
    Product Code
    MLV
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    IN 2003 DR. PLACED A 23MM CARDIOSEAL DEVICE IN A PT. IN THE CATH LAB WHEN THEY WENT BACK WITH ULTRASOUND THEY FOUND THAT THE DEVICE HAD EMBOLIZED INTO THE RIGHT ATRIUM. IT WAS THEN NOTED THAT THE DEVICE SLID THROUGH THE TRICUSPID VALVE INTO THE RIGHT VENTRICLE AND SUBSEQUENTLY INTO THE LEFT PULMONARY ARTERY. THEY THEN USED A #8 FRENCH GUIDE AND STEERED IT BACK INTO THE SHEATH AS FAR AS THEY COULD AND PULLED IT OUT. THEY COULD NOT GET IT TO COME THROUGH THE SOFT TISSUE SO THEY CUT IT DOWN TO PULL IT OUT. THEY THEN REINSERTED THE SHEATH AND STARTED OVER AGAIN AND SUCCESSFULLY DEPLOYED A #28 CARDIOSEAL DEVICE. THE PT WAS TAKEN TO THE ICU FOR RECOVERY. THE PT WAS HYPOTENSIVE AND HAD A RESPIRATORY ARREST. PT WAS INTUBATED AND HAD A MASSIVE PERICARDIAL TEMPONADE. THE PT CARDIAC ARRESTED AND DIED IN 2003.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIOSEAL CS-23-QL-PFO CARDIOSEAL MLV NMT MEDICAL, INC. CS-23-QL-PFO *

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Death