BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 2161399 · Received July 13, 2011

    Report

    Report Number
    2135147-2011-00088
    Event Type
    Injury
    Date Received
    July 13, 2011
    Date of Event
    June 16, 2011
    Report Date
    September 20, 2011
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    PMA / PMN Number
    P000039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IMAGE REVIEW. AGA REQUESTED FURTHER INFORMATION REGARDING THIS CASE, BUT MEDICAL RECORDS AND IMAGES WERE NOT PROVIDED. ECHOCARDIOGRAMS ARE NEEDED TO CONFIRM SIZING AND EVALUATE OTHER PARAMETERS OF THE IMPLANT PROCEDURE. DEVICE ANALYSIS. THE AMPLATZER SEPTAL OCCLUDER WAS RETURNED TO AGA MEDICAL 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 LOADER WITHOUT ANY DEFORMITIES. 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. CONCLUSION: THE RESULTS OF THIS INVESTIGATION ARE INCONCLUSIVE SINCE NO ADDITIONAL INFORMATION WAS RECEIVED. THE CAUSE OF THIS EVENT REMAINS UNKNOWN.

    Additional Manufacturer Narrative · 1

    PROCEDURAL IMAGES RECEIVED INCLUDED FLUOROSCOPIC IMAGES OF BALLOON SIZING AND THE EMBOLIZED DEVICE, TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) DURING DEPLOYMENT AND POST EMBOLIZATION AND DEVICE RETRIEVAL. REVIEW OF THE IMAGES BY SJM'S MEDICAL CONSULTANT INDICATED THAT THE BALLOON DIAMETER WAS 20MM AND TEE SIZING 19.4MM AND A 20 MM DEVICE WAS PLACED. THE DEFECT APPEARED TO BE OVAL SHAPED WITH A MAXIMUM DIMENSION IN SUPERIOR INFERIOR AXIS. THE FIRST ATTEMPT AT PLACEMENT WAS UNSUCCESSFUL AND THE DEVICE PROLAPSED IN THE RIGHT ATRIUM. AFTER MULTIPLE ATTEMPTS, THE DEVICE WAS SNARED AND PULLED INTO THE SHEATH. A DIFFERENT SHEATH WAS USED AND SUBSEQUENT PLACEMENT WAS SUCCESSFUL. MODERATE REGURGITATION OF THE TRICUSPID VALVE WAS SEEN AFTER DEVICE RETRIEVAL. THE CAUSE OF THE EMBOLIZATION DID NOT APPEAR TO BE DEVICE RELATED BUT RATHER RELATED TO PATIENT ANATOMY AND DEVICE SELECTION.

    Description of Event or Problem · 1

    ACCORDING TO THE INITIAL INFORMATION RECEIVED, A 20MM AMPLATZER SEPTAL OCCLUDER (ASO) WAS MEASURED USING BALLOON-SIZING AND IMPLANTED UNDER THE GUIDANCE OF A TRANSESOPHAGEAL ECHOCARDIOGRAM AND FLUOROSCOPY. A 9F AMPLATZER TORQUE 45 DELIVERY SHEATH ((B)(4)) WAS USED BUT DID NOT FORM THE CORRECT POSITION SO A 10F (B)(4) SHEATH WAS THEN PLACED FOR DELIVERY. UPON ACHIEVING HEMOSTASIS, THE PATIENT STARTED HAVING PVC'S AND FLUOROSCOPY REVEALED THE (B)(4) HAD MIGRATED TO THE RIGHT VENTRICLE. A 15MM SNARE CATHETER WAS USED TO RETRIEVE THE (B)(4). DEVICE. THE PATIENT WAS STABLE. ADDITIONAL INFORMATION INCLUDING IMAGES HAVE BEEN REQUESTED; WHEN MORE INFORMATION AVAILABLE, AN UPDATED REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZER SEPTAL OCCLUDER CARDIAC OCCLUSION DEVICE MLV AGA MEDICAL CORPORATION 9-ASD-020 1003040274

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Required Intervention