BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIOSEAL SEPTAL OCCLUDER

    MDR report key: 752164 · Received August 7, 2006

    Report

    Report Number
    MW1039967
    Event Type
    Injury
    Date Received
    August 7, 2006
    Date of Event
    July 20, 2006
    Report Date
    July 24, 2006
    Manufacturer
    NMT TECHNOLOGIES, INC.
    Product Code
    MLV
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A MAN UNDERWENT EVALUATION FOR MULTIPLE NEUROLOGIC EVENTS, INCLUDING AMAUROSIS FUGAX, AND 2 EPISODES OF TRANSIENT HEMISENSORY DEFICITS ASSOCIATED WITH DYSARTHRIA. TEE SHOWED A PFO AND 2 ADD'L FENESTRATIONS OF THE INTERATRIAL SEPTUM. THE REMAINDER OF HIS EVAL WAS NORMAL. NEUROLOGY CONSULTATION RECOMMENDED PFO CLOSURE. THE PPO WAS SIZED AT 12MM WITH A SIZING BALLOON. A 33MM NMT CARDIOSEAL SEPTAL OCCLUDER WAS SUCCESSFULLY IMPLANTED (REF #CS-33-QL-PPO, LOT # 0511170), WHICH CLOSED THE PFO AND FENESTRATIONS. THREE HOURS AFTER THE PROCEDURE, CARDIAC TAMPONADE DEVELOPED. PERCUTANEOUS DRAINAGE SUCCESSFULLY RELEIVED THE TAMPONADE, BUT BLOODY PERICARDIAL DRAINAGE PERSISTED. THE PT WAS TAKEN TO THE OR, WHICH SHOWED A SMALL PERFORATION OF THE AORTA. THIS WAS FELT TO BE SECONDARY TO ONE OF THE LEGS OF THE DEVICE PERFORATING THROUGH THE RIGHT ATRIUM INTO THE AORTA. THE VERY EXPERIENCED CARDIAC SURGEON LEFT THE DEVICE IN PLACE, AND OVERSEWED THE RIGHT ATRIUM AND AORTA WITH PERICARDIAL PATCHES. THE PT IS RECOVERING WELL FROM CARDIAC SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIOSEAL SEPTAL OCCLUDER * MLV NMT TECHNOLOGIES, INC. CS-33-QL-PPO 511170

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| L| O