BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER DUCT OCCLUDER

    MDR report key: 2161432 · Received July 13, 2011

    Report

    Report Number
    2135147-2011-00089
    Event Type
    Injury
    Date Received
    July 13, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 22, 2011
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MAE
    PMA / PMN Number
    P020024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION INCLUDING IMAGES WERE REQUESTED. WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE, AN AMENDED REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    DEVICE "MIGRATION" WAS INITIALLY REPORTED TO US, HOWEVER, OUR MEDICAL CONSULTANT WHO REVIEWED THE IMAGING CONCLUDED THAT THE DEVICE "EMBOLIZED" FROM ITS INTENDED LOCATION. THEREFORE, WE UPDATED OUR EVENT RECORD TO ACCOUNT FOR THIS CHANGE.WE HAVE LOGGED THIS EVENT IN OUR COMPLAINT HANDLING SYSTEM AND WILL CONTINUE TO MONITOR OVERALL PRODUCT PERFORMANCE TO IDENTIFY ANY PATTERNS IN FIELD EVENTS

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS: THE AMPLATZER DUCT OCCLUDER WAS RETURNED TO AGA MEDICAL BLOODY WITH PARTIAL TISSUE INGROWTH. 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 COULD NOT BE ATTACHED TO A TEST DELIVERY CABLE FOR LOADING AND DEPLOYMENT TESTS AS THE DEVICE'S END SCREW WAS BLOCKED WITH TISSUE INGROWTH. 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. IMAGING REVIEW: REVIEW OF THE MEDICAL RECORDS AND IMAGES BY AGAS MEDICAL CONSULTANT RESULTED IN THE FOLLOWING FINDINGS: THIS (B)(6), UNDERWENT PDA CLOSURE WITH A 6/4MM ADO. THE NEXT DAY, HOWEVER, THE DEVICE WAS SEEN TO HAVE EMBOLIZED INTO THE DESCENDING AORTA. THE PATIENT WAS REFERRED FOR SURGERY. THE DEVICE WAS REMOVED AND THE PDA LIGATED. THREE CDS WERE PROVIDED FOR REVIEW: TWO CONTAINED THE ECHOCARDIOGRAMS AND ONE CONTAINED THE CINE-ANGIOGRAMS. THE ECHO CDS SHOWED PDA WITH LEFT TO RIGHT FLOW. THE ECHO OBTAINED AFTER THE DEVICE HAD EMBOLIZED SHOWED THE DEVICE IN THE DESCENDING AORTA. THE CINEANGIOGRAMS SHOWED THE PDA WITH A GOOD-SIZE AMPULLA AND ITS LENGTH WAS ADEQUATE FOR DEVICE PLACEMENT. ALTHOUGH NO MEASUREMENTS WERE RECORDED IN THE ANGIOS THAT WERE SUBMITTED FOR REVIEW, THE PDA DEVICE APPEARED TO BE IN GOOD POSITION FOLLOWING DEVICE PLACEMENT. THERE WAS TRACE RESIDUAL SHUNT ACROSS THE PDA. THE WAIST OF THE DEVICE WAS CONSTRICTED AND HENCE THE DEVICE WAS OF APPROPRIATE SIZE. CONCLUSION: ACCORDING TO AGAS MEDICAL CONSULTANT, THE EXACT CAUSE OF EMBOLIZATION COULD NOT BE DETERMINED SINCE THE DEVICE SIZE AND PLACEMENT WERE OPTIMAL INCLUDING OPTIMAL EVALUATION OF THE PDA PRIOR TO DEVICE PLACEMENT AND OPTIMAL DEVICE SELECTION BASED UPON THE MORPHOLOGY OF THE DEFECT.

    Description of Event or Problem · 1

    ACCORDING TO THE INITIAL INFORMATION RECEIVED, A 6/4MM AMPLATZER DUCT OCCLUDER (ADO) WAS SUCCESSFULLY IMPLANTED IN A (B)(6) FEMALE PATIENT ((B)(6)) ON (B)(6) 2011. THE DEFECT WAS MEASURED USING THE GUIDANCE OF A SIZING BALLOON, ECHOCARDIOGRAM AND FLUOROSCOPY. DEVICE POSITION WAS VERIFIED ON ULTRASOUND. THE NEXT DAY, A REPEAT ULTRASOUND WAS TAKEN WHICH SHOWED THE ADO HAD MIGRATED TO THE AORTA. THE PATIENT WAS REFERRED FOR SURGERY TO HAVE THE ADO REMOVED. THE PATIENT WAS IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZER DUCT OCCLUDER CARDIAC OCCLUSION DEVICE MAE AGA MEDICAL CORPORATION 9-PDA-004 1003170717

    Patients

    Seq Age Sex Outcome Treatment
    1 18 MO Required Intervention