BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER® SEPTAL OCCLUDER

    MDR report key: 2183009 · Received July 28, 2011

    Report

    Report Number
    2135147-2011-00092
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    July 6, 2011
    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
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IMAGING REVIEW: REVIEW OF FOUR CDS AND CATHETERIZATION FLOW SHEETS BY AGAS MEDICAL CONSULTANT RESULTED IN THE FOLLOWING FINDINGS: THE PROCEDURE WAS PERFORMED UNDER TEE GUIDANCE. A THOROUGH TEE WAS PERFORMED TO DELINEATE THE PATIENT'S CARDIAC ANATOMY. THE AV VALVES WERE OFFSET WITH THE TRICUSPID VALVE HIGHER THAN THE MITRAL VALVE - TYPICAL OF CORRECTED TRANSPOSITION. THERE WAS NO AORTIC RIM SEEN IN ONE VIEW. THE POSTERIOR RIM WAS OF GOOD SIZE BUT SLIGHTLY THIN TOWARD ITS TIP. THE SVC AND IVC RIMS WERE OF GOOD SIZE. THE RIM TOWARD THE PULMONARY VEIN WAS GOOD SIZED AS WELL. THE STATIC DIAMETER MEASURED FROM 13-16MM. HOWEVER, TEE VIEWS BEFORE BALLOON SIZING, SHOWED THE DEFECT AS 19MM IN 45-DEGREES AND 83-DEGREES. THE DEFECT WAS SMALL IN BI-CAVAL VIEW. BALLOON SIZING WAS PERFORMED WITH BBRAUN 25MM BALLOON USING STOP-FLOW TECHNIQUE. THE DIAMETER WAS MEASURED 17.5MM AND AN 18MM ASO WAS CHOSEN. AFTER THE ASO WAS DEPLOYED, THE RIGHT DISC APPEARED TILTED TOWARD THE LEFT SIDE. THERE WAS HINT OF SHUNT IN 4-CHAMBER VIEW CLOSE TO THE AV VALVES AND IN BI-CAVAL VIEW CLOSE TO THE IVC RIM. THE ASO WAS STABLE TOWARD THE PULMONARY VENOUS SIDE AND PROTRUDING SLIGHTLY IN THE PULMONARY VEIN WITHOUT ANY EVIDENCE OF OBSTRUCTION. IT APPEARED STABLE IN BI-CAVAL VIEW ALBEIT SOME SHUNT TOWARD THE IVC RIMS. SEVERAL ECHO LOOPS SHOWED EMBOLIZED ASO IN THE MORPHOLOGIC RIGHT VENTRICLE WITH SUGGESTION OF ENTRAPMENT UNDER THE TRICUSPID VALVE. ANALYSIS RESULTS: THE ASO 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 8F LOADER WITHOUT ANY DEFORMITIES. 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. A REVIEW OF MANUFACTURING DOCUMENTATION CONFIRMED THIS DEVICE SUCCESSFULLY COMPLETED THESE TESTS CONCLUSION: ACCORDING TO AGAS MEDICAL CONSULTANT, THE FOLLOWING CONCLUSIONS WERE DRAWN: BALLOON SIZING WAS PERFORMED ACCORDING TO THE INSTRUCTIONS FOR USE. THE DEFECT WAS OVAL AND THE CARDIAC ANATOMY WAS COMPLEX. A 4-CHAMBER VIEW SHOWED THE ASO WAS UNSTABLE AS THE RIGHT DISC TILTED TOWARD THE LEFT SIDE AND LATER EMBOLIZED TO THE LEFT SIDE. THERE WAS EVIDENCE OF RESIDUAL SHUNT TOWARD THE IVC RIM AND THE AV VALVE RIM. THE ASO WAS ENTRAPPED UNDER THE TRICUSPID VALVE CHORDAE REQUIRING SURGICAL REMOVAL.

    Description of Event or Problem · 1

    A (B)(6) YEAR-OLD HAD A HISTORY OF CORRECTED TRANSPOSITION, SUB-PULMONARY STENOSIS, ATRIAL SEPTAL DEFECT (ASD) WITH BI-DIRECTIONAL SHUNTING, AND HISTORY OF RIGHT-TO-LEFT SHUNT WITH EXERCISE. THE PATIENT UNDERWENT CARDIAC CATHETERIZATION PROCEDURE FOR DEVICE CLOSURE OF THE ASD. THE DEFECT WAS BALLOON SIZED TO STOP-FLOW TO 17MM. AN 18MM AMPLATZER SEPTAL OCCLUDER (ASO) WAS IMPLANTED. THE ASO WAS CLOSE TO THE RIGHT UPPER PULMONARY VEIN BUT DID NOT AFFECT FLOW. THE ASO WAS RELEASED AND WAS STABLE ON TEE AND FLUOROSCOPY. THE FOLLOWING DAY, X-RAY DEMONSTRATED THE DEVICE EMBOLIZED TO THE RIGHT VENTRICLE AND WAS CONFIRMED BY ECHO. THE PATIENT WAS TAKEN TO THE OR FOR DEVICE REMOVAL AND ASD PATCH CLOSURE. THE ASO WAS ENTANGLED IN THE TRICUSPID VALVE LEAFLET CHORDAE; THEREFORE, PERCUTANEOUS REMOVAL COULD NOT BE ATTEMPTED. ALSO, THERE WERE NO OTHER GOOD OPTIONS OF DEVICE CLOSURE AS A LARGER DEVICE WOULD HAVE LIKELY PUSHED INTO THE PULMONARY VEIN ORIFICE. THE PATIENT DID WELL IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZER® SEPTAL OCCLUDER CARDIAC OCCLUSION DEVICE MLV AGA MEDICAL CORPORATION 9-ASD-018 M07H27-17

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Required Intervention