BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 2840686 · Received November 20, 2012

    Report

    Report Number
    2135147-2012-00173
    Event Type
    Injury
    Date Received
    November 20, 2012
    Date of Event
    October 19, 2012
    Report Date
    November 2, 2012
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    PMA / PMN Number
    P000039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING MANUFACTURING, THIS DEVICE UNDERWENT A SERIES OF INSPECTIONS AND TESTS TO CONFIRM PROPER FUNCTION, INCLUDING A TEST SIMULATING LOADING AND DEPLOYMENT. A REVIEW OF MANUFACTURING DOCUMENTATION CONFIRMED THIS DEVICE SUCCESSFULLY COMPLETED THESE TESTS. THE AMPLATZER SEPTAL OCCLUDER WAS RETURNED TO SJM IN ITS ORIGINAL CONFIGURATION. FOLLOWING DECONTAMINATION, THE DEVICE WAS MEASURED AND THE SIZE WAS CONFIRMED TO MEET DIMENSIONAL SPECIFICATIONS. THE DEVICE WAS EXAMINED MICROSCOPICALLY AND NO DEFECTS WERE OBSERVED. THE DEVICE WAS LOADED AND DEPLOYED FROM A TEST 8F TORQVUE LOADER WITHOUT ANY DEFORMITIES. OUR INVESTIGATION WAS NOT ABLE TO DETERMINE THE CAUSE OF THE EVENT. BASED ON THE INFORMATION RECEIVED, THE CAUSE REMAINS UNKNOWN.

    Description of Event or Problem · 1

    A 20 MM AMPLATZER SEPTAL OCCLUDER (ASO) WAS DEPLOYED, BUT APPEARED TO LIE IN A PERPENDICULAR PLANE UNDER FLUOROSCOPY AND TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE). THE ASO WAS REMOVED AND AN 18 MM ASO WAS PREPPED AND ADVANCED THROUGH THE DELIVERY SYSTEM ACROSS THE DEFECT. THERE APPEARED TO BE SOME IMPINGEMENT AT THE RIGHT LOWER PULMONARY VEIN ORIFICE AND THERE WAS A SMALL ANTEROINFERIOR DEFECT, WHICH APPEARED AT THE RIGHT AND LEFT ARTERIAL DISCS OF THE ASO. THE ASO WAS RELEASED FROM THE DELIVERY CABLE AND SUBSEQUENT TRANSESOPHAGEAL ECHOCARDIOGRAMS (TEE) SHOWED CONTINUED IMPINGEMENT ON THE LEFT LOWER PULMONARY VEIN ORIFICE AND SHUNTING THROUGH THE ANTEROINFERIOR DEFECT. AFTER MULTIPLE ATTEMPTS, THE DEVICE WAS SNARED AND THE PATIENT WAS SCHEDULED FOR SURGICAL REPAIR OF THE ATRIAL SEPTAL DEFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZER SEPTAL OCCLUDER CARDIAC OCCLUSION DEVICE MLV AGA MEDICAL CORPORATION 9-ASD-018 1107279791

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Hospitalization| R