BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 1251903 · Received December 8, 2008

    Report

    Report Number
    2135147-2008-00130
    Event Type
    Injury
    Date Received
    December 8, 2008
    Report Date
    December 8, 2008
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    PMA / PMN Number
    P000039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISCARDED POST-SURGICAL PROCEDURE AND WILL NOT BE AVAILABLE FOR INVESTIGATION. REVIEW OF THE MEDICAL RECORDS AND IMAGING BY AGAS MEDICAL CONSULTANT RESULTED IN THE FOLLOWING FINDINGS: THIS WAS A MALE THAT UNDERWENT CLOSURE OF A SECUNDUM ASD. A DETAILED REPORT OF THE IMAGING, TEE AND ICE WERE PROVIDED WITH BOTH THE TEE AND ICE IMAGES BEING ADEQUATE. THE TEE DEMONSTRATED A SECUNDUM ASD. THE ATRIAL SEPTUM IN THE 4-CHAMBER VIEW WAS THIN AND THE ASD WAS NOT SEEN. THE ASD WAS SEEN WELL IN THE SHORT AXIS AND BI-CAVAL VIEWS AND BY AGAS MEDICAL CONSULTANT MEASUREMENT WAS ABOUT 18MM AND 17MM RESPECTIVELY. THE REMAINDER OF THE ANATOMY WAS NORMAL FROM AN ASD POINT OF VIEW. ICE WAS PERFORMED DURING THE DEVICE CLOSURE. THERE WAS A SUGGESTION OF TWO DEFECTS IN THE THIN ATRIAL SEPTUM. THE DISTANCE BETWEEN THE TWO DEFECTS WAS MINIMAL AND THE SEPTUM WAS FRAIL. BALLOON SIZING WAS PERFORMED AND STRONGLY SUGGESTED THAT THERE WERE TWO DEFECTS AT INITIAL INFLATION. WITH FURTHER INFLATION THE DEFECT ENLARGED AND BALLOON SIZING LOOKED ADEQUATE WITH A BALLOON STOP-FLOW DIAMETER OF 19MM. A 20MM AMPLATZER SEPTAL OCCLUDER WAS IMPLANTED WITHOUT ANY DIFFICULTY. THE ECHO IMAGES SHOWED THE LEFT ATRIAL DISC TOWARDS THE AORTA, PROTRUDING INTO THE RIGHT ATRIUM. THE DEVICE EMBOLIZED LATER INTO THE LEFT VENTRICLE. THE PATIENT WAS REFERRED TO SURGERY FOR REMOVAL OF THE DEVICE, REPAIR OF THE DEFECT AND MAZE PROCEDURE. THE ULTIMATE OUTCOME WAS UNEVENTFUL. ACCORDING TO AGAS MEDICAL CONSULTANT, THE DEFECT MEASUREMENT WAS CORRECT. THE BALLOON SIZING WAS ADEQUATE AND PER AGA RECOMMENDATIONS. THE SELECTED DEVICE SIZE WAS CORRECT; HOWEVER, THE DEVICE ORIENTATION AFTER DEPLOYMENT TOWARDS THE AORTIC RIM WAS TROUBLESOME. THE EDGE OF THE LEFT ATRIAL DISC THAT PROTRUDED INTO THE RIGHT ATRIAL SIDE WAS STRONGLY SUGGESTIVE THAT THE DEVICE WAS NOT BEING HELD BY THE TRUE AORTIC RIM. AS THE SEPTUM GAVE IN LATER, THE DEVICE EMBOLIZED. IN SUCH A SITUATION, THE DEVICE WILL NOT EMBOLIZE IF THE ATRIAL SEPTUM THAT HOLDS THE DEVICE DOES NOT "GIVE IN". IN THE MAJORITY OF THE CASES THE SEPTUM REMAINS STABLE AND THE DEVICE DOES NOT EMBOLIZE; HOWEVER, THIS IS A DIFFICULT PROBLEM TO PREDICT AS THE NUMBERS OF CASES ENCOUNTERED WITH THIS TYPE OF ANATOMY ARE FEW. HOWEVER, IF THE EDGE OF THE DEVICE IS SEEN PROTRUDING TOWARD THE OPPOSITE ATRIUM (LEFT EDGE PROTRUDING TO THE RIGHT SIDE), IT SHOULD RAISE THIS POSSIBILITY.

    Description of Event or Problem · 1

    IN 2008, AN AMPLATZER SEPTAL OCCLUDER WAS IMPLANTED. BALLOON SIZING WAS PERFORMED WITH A 24MM AMPLATZER SIZING BALLOON AND MEASURED 18MM. THE PATIENT TOLERATED THE PROCEDURE WELL. THE FOLLOWING MONTH, THE PATIENT PRESENTED TO HIS CARDIOLOGIST WITH CONGESTIVE HEART FAILURE, AND ON ECHOCARDIOGRAPHY IT WAS NOTED THE DEVICE HAD EMBOLIZED TO THE LEFT VENTRICLE OUTFLOW TRACT; HOWEVER, IT WAS UNKNOWN AT WHAT POINT. THE DEVICE WAS SURGICALLY REMOVED AND THE ATRIAL SEPTAL DEFECT WAS SURGICALLY REPAIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZER SEPTAL OCCLUDER AMPLATZER SEPTAL OCCLUDER MLV AGA MEDICAL CORPORATION 9-ASD-020 M06L06-35

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention