BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 3033729 · Received April 3, 2013

    Report

    Report Number
    2135147-2013-00029
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    March 15, 2013
    Report Date
    March 15, 2013
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    PMA / PMN Number
    P000039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE AMPLATZER SEPTAL OCCLUDER WAS RECEIVED SJM AND WAS DECONTAMINATED. THE OCCLUDER WAS GROSSLY AND MICROSCOPICALLY EXAMINED, AND NO ANOMALIES WERE FOUND. IT MET DIMENSIONAL SPECIFICATIONS WHEN MEASURED WITH A CALIBRATED CALIPER. THE DEVICE WAS LOADED INTO A TEST 8F LOADER, DEPLOYED AND RETRACTED WITHOUT DIFFICULTY OR DEFORMATION. 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. THIS EVENT WAS REVIEWED BY (B)(4) AND CONFIRMED THAT EROSION OCCURRED.

    Description of Event or Problem · 1

    A PRE-INSERTION TRANSTHORACIC ECHO WAS PERFORMED CONFIRMING THE SIZE OF THE DEFECT AND IDENTIFIED A LARGE SECUNDUM SEPTAL EFFECT WITH A LEFT TO RIGHT SHUNT. A PATIENT WAS IMPLANTED WITH AN 18 MM AMPLATZER SEPTAL OCCLUDER (ASO). A TRANSESOPHAGEAL ECHO (TEE) SHOWED A SLIGHT INDENTATION OF THE AORTIC ROOT BY THE ATRIAL DISC SO IT WAS REMOVED AND REPLACED WITH A 16 MM ASO DEVICE. A FOLLOW UP TEE WAS PERFORMED AND IT CONFIRMED GOOD PLACEMENT. THE FOLLOWING DAY THE PATIENT COMPLAINED OF VAGUE CHEST PAIN AND AN ECHOCARDIOGRAM WAS PERFORMED. THE PATIENT WAS ADMITTED AND MONITORED OVERNIGHT. TWO DAYS POST IMPLANT, THE PATIENT EXPERIENCED SEVERE CHEST PAIN AND SURGICAL REMOVAL OF THE 16 MM ASO AND GORTEX PATCH GRAFT REPAIR OF THE LEFT ATRIA AND AORTA WAS PERFORMED. SURGICAL FINDINGS REVEALED A 3X3 MM HOLE IN THE LEFT ATRIUM AND PERICARDIAL EFFUSION. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS DISCHARGED 5 DAYS LATER IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136393 AMPLATZER SEPTAL OCCLUDER CARDIAC OCCLUSION DEVICE MLV AGA MEDICAL CORPORATION 9-ASD-016 1203149133

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Hospitalization| R