BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 2039346 · Received April 5, 2011

    Report

    Report Number
    2135147-2011-00027
    Event Type
    Injury
    Date Received
    April 5, 2011
    Date of Event
    April 4, 2011
    Report Date
    April 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 32MM ASO WAS RETURNED TO AGA MEDICAL IN ITS ORIGINAL CONFIGURATION WITH DRIED BLOOD. DURING DECONTAMINATION, THE STITCHING WAS INADVERTENTLY DAMAGED DURING ATTEMPTS TO REMOVE THE DRIED BLOOD; HOWEVER, THE STITCHING WAS INTACT PRIOR TO DECONTAMINATION. 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. DURING MANUFACTURING, THIS DEVICE UNDERWENT A SERIES OF INSPECTIONS AND TESTS TO CONFIRM PROPER FUNCTION, INCLUDING A TEST SIMULATING LOADING AND DEPLOYMENT AND VERIFICATION OF DEVICE SIZING. A REVIEW OF MANUFACTURING DOCUMENTATION CONFIRMED THIS DEVICE SUCCESSFULLY COMPLETED THESE TESTS. REVIEW OF THE MEDICAL RECORDS AND IMAGES BY AGA'S MEDICAL CONSULTANT RESULTED IN THE FOLLOWING FINDINGS: THIS ADULT FEMALE PATIENT UNDERWENT ASO PLACEMENT FOR A LARGE ATRIAL SEPTAL DEFECT (ASD). THE ASO EMBOLIZED WHILE THE PATIENT WAS IN THE HOSPITAL AND THE PATIENT UNDERWENT A REPEAT CATH. IT IS UNCLEAR IF ATTEMPTS WERE MADE TO RETRIEVE THE ASO PERCUTANEOUSLY AND THE PATIENT UNDERWENT SURGICAL REMOVAL OF THE ASO AND CLOSURE OF THE ASD. FOUR CDS WERE PROVIDED FOR REVIEW. TWO CONTAINED ECHOCARDIOGRAMS OF THE IMPLANTATION AND TWO CDS CONTAINED FLUOROSCOPIC IMAGES OF THE BALLOON SIZING, THE ASO IMPLANTATION PROCEDURE AND OF THE EMBOLIZED ASO. THE PROCEDURE WAS PERFORMED UNDER TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) GUIDANCE. THE SCANNING OF THE ATRIAL SEPTUM WAS OF FAIR QUALITY. THE RECORDED IMAGES WERE IN BI-CAVAL VIEW MOSTLY, A FEW IN SHORT-AXIS VIEW AND NO IMAGES IN 4-CHAMBER VIEW. THE ATRIAL SEPTUM WAS THIN AND FLAILING IN THE IVC AND THE POSTERIOR RIM AREA. THE AORTIC RIM WAS ABSENT IN AT LEAST ONE VIEW AND THE SUPERIOR AND AV VALVE RIMS WERE NOT INTERROGATED. THE STATIC DIAMETER OF THE DEFECT WAS ROUGHLY 28MM IN THE BI-CAVAL VIEW. THE DEFECT WAS OVAL IN SHAPE AND WAS DYNAMIC IN NATURE. BALLOON SIZING WAS PERFORMED AND IT APPEARED THAT IT WAS SOMEWHAT DIFFICULT TO KEEP THE BALLOON ASTRIDE THE ASD. NEVERTHELESS, THE DIAMETER OF THE DEFECT WAS MORE THAN 32MM WHEN STOP-FLOW DIAMETER WAS ACHIEVED DURING BALLOON SIZING. AFTER A SUCCESSFUL DEPLOYMENT, THE ASO APPEARED TO HAVE A THIN PROFILE AND BARELY HUNG ON TO THE ATRIAL SEPTUM. THE CD OF THE FLUOROSCOPY REVEALED THE EFFORTS OF BALLOON SIZING FOLLOWED BY ASO PLACEMENT. THE FIRST FEW ATTEMPTS AT PROPER DEPLOYMENT FAILED. AFTER THE ASO WAS IMPLANTED IT HAD A VERY THIN PROFILE. ACCORDING TO AGA'S MEDICAL CONSULTANT, THE FOLLOWING CONCLUSIONS WERE DRAWN: THIS WAS A COMPLEX DEFECT WITH THIN RIMS. THIS WAS AN OVAL DEFECT WHICH WAS HYPER-DYNAMIC IN NATURE. THE SIZE OF THE DEFECT WAS UNDERESTIMATED EVEN DURING BALLOON SIZING AS THE SIZING BALLOON KEPT MOVING IN AND OUT OF THE DEFECT. THERE WERE ADEQUATE BUT THIN IVC AND POSTERIOR RIMS, A GOOD SIZED SVC RIM, AND THE AORTIC RIM WAS ABSENT. THE PRIMARY CAUSE OF THIS DEVICE EMBOLIZATION WAS DEVICE UNDERSIZING. ADDITIONALLY, THE SEPTUM SHOULD HAVE BEEN INTERROGATED BEFORE AND AFTER DEVICE PLACEMENT THOROUGHLY. THIS MAY HAVE PREVENTED EMBOLIZATION OF THE DEVICE.

    Description of Event or Problem · 1

    ACCORDING TO THE INITIAL INFORMATION RECEIVED, THE 32MM AMPLATZER SEPTAL OCCLUDER EMBOLIZED PRIOR TO DISCHARGE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, INCLUDING IMAGING OF THE IMPLANT PROCEDURE AND PATIENT INFORMATION, BUT HAS NOT YET BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZER SEPTAL OCCLUDER CARDIAC OCCLUSION DEVICE MLV AGA MEDICAL CORPORATION 9-ASD-032 0909084495

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Required Intervention