BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 1243365 · Received November 26, 2008

    Report

    Report Number
    2135147-2008-00109
    Event Type
    Injury
    Date Received
    November 26, 2008
    Date of Event
    August 1, 2005
    Report Date
    May 25, 2011
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    PMA / PMN Number
    P000039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THIS INVESTIGATION ARE INCONCLUSIVE SINCE THE IMPLANT ECHOCARDIOGRAMS OR MEDICAL RECORDS WERE NOT PROVIDED TO AGA MEDICAL FOR REVIEW. ECHOCARDIOGRAMS ARE NEEDED TO CONFIRM SIZING AND EVALUATE OTHER PARAMETERS OF THE IMPLANT PROCEDURE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, AGA MEDICAL WILL FILE A SUPPLEMENT REPORT.

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS REVIEWED BY AGA MEDICAL EROSION BOARD CHAIRS ON 29 APRIL 2011 AND DEFINITE EROSION WAS CONFIRMED.

    Description of Event or Problem · 1

    A 17MM AMPLATZER SEPTAL OCCLUDER WAS IMPLANTED IN AN ASD THAT MEASURED 13 X 15MM ON ECHO, WITH A STRETCHED BALLOON DIAMETER OF 17.5MM WITH ADEQUATE RIMS. THE INTERATRIAL SEPTUM MEASURED 37MM IN TOTAL LENGTH. THERE WAS NO RESIDUAL SHUNT OR IMPINGENT ON INTRACARDIAC STRUCTURES. THE PATIENT WAS ASYMPTOMATIC BEFORE COLLAPSE ONE DAY POST-IMPLANT. URGENT ECHO SHOWED A SIGNIFICANT PERICARDIAL EFFUSION WITH SIGNS OF TAMPONADE. PERICARDIOCENTESIS WAS PERFORMED, WHICH REVEALED DARK, GROSS BLOOD. WITH THE PATIENT BECOMING UNSTABLE, SHE WAS INTUBATED. ONCE STABILIZED, EMERGENT SURGICAL EXPLORATION FOUND A HEMOPERICARDIUM, AND PERFORATIONS WERE IDENTIFIED IN THE ANTEROSUPERIOR RIGHT ATRIAL WALL AND THE CONTIGUOUS NONCORONARY SINUS OF THE AORTIC ROOT. THE AORTA WAS OPENED, THE DEVICE WAS REMOVED AND THE PERFORATIONS AND ASD WERE REPAIRED. THE POSTOPERATIVE COURSE WAS UNEVENTFUL AND FREE OF NEUROLOGICAL EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZER SEPTAL OCCLUDER CARDIAC OCCLUSION DEVICE MLV AGA MEDICAL CORPORATION 9-ASD-017

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Required Intervention