BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER® SEPTAL OCCLUDER

    MDR report key: 2240781 · Received September 9, 2011

    Report

    Report Number
    2135147-2011-00104
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    December 22, 2010
    Report Date
    November 1, 2011
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    PMA / PMN Number
    P000039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IMAGING REVIEW: REVIEW OF THE INTRA-PROCEDURE ECHOCARDIOGRAM BY AGAS MEDICAL CONSULTANT RESULTED IN THE FOLLOWING FINDINGS: THIS ADULT MALE UNDERWENT CLOSURE OF A PFO WITH AN ASO. AFTER THE ASO WAS RELEASED, IT MIGRATED TOWARD THE LEFT ATRIUM BUT STAYED IN THE ATRIAL TUNNEL. THE ASO WAS SNARED AND REMOVED. THE PROCEDURE WAS NOT ATTEMPTED AGAIN. THE PROCEDURE WAS PERFORMED UNDER TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) GUIDANCE. THE ATRIAL SEPTUM WAS EVALUATED IN ALL THREE STANDARD VIEWS. THE 4-CHAMBER VIEW AT 0-DEGREES SHOWED COMPLICATED ATRIAL LEVEL COMMUNICATIONS. A DEFINITE ATRIAL LEVEL COMMUNICATION TYPICAL OF A PFO (FROM AORTIC SIDE WITH LEFT-TO-RIGHT FLOW) WAS OBSERVED, HOWEVER, THE SEPTUM PRIMUM WAS THIN, REDUNDANT AND STRETCHED TOWARD THE SEPTUM SECUNDUM TOWARD THE POSTERIOR RIM, WHERE IT SEEMED TO ATTACH ON THE LEFT SIDE OF THE SEPTUM SECUNDUM. THE AORTIC RIM, POSTERIOR RIM, THE AV VALVE RIM, THE SVC AND THE IVC RIMS WERE ADEQUATE AND OF GOOD SIZE. THE THIN SEPTUM PRIMUM HAD MULTIPLE OPENINGS (PFO TYPE, FENESTRATIONS, AND AN ADDITIONAL DEFECT TOWARD THE POSTERIOR RIM WHICH WAS SEPARATED FROM THE PFO BY A SIGNIFICANT DISTANCE). BALLOON SIZING WAS PERFORMED AND THE STRETCHED DIAMETER OF THE DEFECT RANGED FROM 26.4 TO 27MM. A 28MM ASO WAS DEPLOYED AND RELEASED. IN THE SHORT-AXIS VIEW, THE ASO WAS STABLE AS THE RIGHT ATRIAL DISC COVERED THE AORTIC RIM ADEQUATELY. IN THE BI-CAVAL VIEW, HOWEVER, THE SVC RIM WAS NOT COVERED ADEQUATELY. AFTER THE ASO WAS RELEASED, THE RIGHT ATRIAL DISC MIGRATED INTO THE LEFT SIDE OF THE SVC RIM. THIS MIGRATION UNCOVERED THE ATRIAL SEPTAL TUNNEL AND RESIDUAL SHUNT WAS SEEN FROM THE TUNNEL IN ADDITION TO THE DEFECT TOWARD THE POSTERIOR RIM. ANALYSIS RESULTS: AGA MEDICAL COULD NOT EVALUATE THE PRODUCT INVOLVED IN THIS EVENT SINCE IT WAS NOT RETURNED TO US. MANUFACTURING RECORD REVIEW: 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. CONCLUSION: ACCORDING TO AGAS MEDICAL CONSULTANT THE FOLLOWING CONCLUSIONS WERE DRAWN: THE DEFECT WAS A VERY COMPLEX PFO AND RESULTED IN THE MIGRATION OF THE ASO. MULTIPLE LEVEL ATRIAL SEPTAL SHUNTING WAS OBSERVED WITH A REDUNDANT ATRIAL SEPTUM. THIN, REDUNDANT, CURTAIN LIKE SEPTUM PRIMUM WAS ATTACHED ON THE LEFT SIDE OF THE SEPTUM SECUNDUM TOWARD THE AORTIC, SVC, AND POSTERIOR RIMS. THE DISTANCE BETWEEN THE EDGE OF SEPTUM SECUNDUM TOWARD THE IVC SIDE AND THE SVC WAS ABOUT 38MM. THE ASO RIGHT ATRIAL DISC MEASURES 38MM. THERE WAS NO MARGIN OF SAFETY WITH A 28MM ASO; AND THEREFORE, MIGRATED INTO THE LEFT ATRIAL SIDE OF THE SVC.

    Description of Event or Problem · 1

    ACCORDING TO THE INFORMATION RECEIVED, DURING IMPLANT OF THE AMPLATZER SEPTAL OCCLUDER (ASO), THE RIGHT ATRIAL DEVICE EMBOLIZED INTO THE TUNNEL AFTER THE DELIVERY CABLE WAS DETACHED AND IT WAS REMOVED WITH A SNARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZER® SEPTAL OCCLUDER CARDIAC OCCLUSION DEVICE MLV AGA MEDICAL CORPORATION 9-ASD-028

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention