BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 1930274 · Received December 16, 2010

    Report

    Report Number
    2135147-2010-00178
    Event Type
    Injury
    Date Received
    December 16, 2010
    Date of Event
    November 11, 2010
    Report Date
    January 26, 2011
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    PMA / PMN Number
    P000039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGA MEDICAL COULD NOT EVALUATE THE ASO INVOLVED IN THIS INCIDENT SINCE IT WAS NOT RETURNED TO US. THE DEVICE'S MANUFACTURING RECORDS COULD NOT BE REVIEWED SINCE THE LOT NUMBER WAS NOT PROVIDED. HOWEVER, EACH DEVICE IS INSPECTED BY CERTIFIED OPERATORS TO ENSURE EACH DEVICE IS ACCEPTABLE DURING MANUFACTURING AND PRIOR TO SHIPMENT. REVIEW OF THE MEDICAL RECORDS AND IMAGES BY AGA'S MEDICAL CONSULTANT RESULTED IN THE FOLLOWING FINDINGS: THIS PATIENT UNDERWENT ASO PLACEMENT FOR A SECUNDUM ATRIAL SEPTAL DEFECT (ASD). THE ASO EMBOLIZED THE DAY OF THE PROCEDURE AND WAS RETRIEVED PERCUTANEOUSLY FROM THE AORTA. NO INFORMATION WHETHER ANOTHER DEVICE WAS ATTEMPTED WAS REPORTED. ONE CD WITH TWO ECHOCARDIOGRAMS WAS PROVIDED FOR REVIEW. THE FIRST ECHOCARDIOGRAM WAS THE TEE THAT WAS PERFORMED DURING THE ASO IMPLANTATION. THE SECOND ECHOCARDIOGRAM WAS THE TTE AND DID NOT PROVIDE MUCH VALUABLE INFORMATION FOR THIS REVIEW. HOWEVER, THE TEE WAS OF GOOD QUALITY AND SHOWED A MEDIUM SIZED ASD WITH A LEFT TO RIGHT SHUNT. THE ATRIAL SEPTUM WAS THIN, ANEURYSMAL AND BOWED INTO THE RIGHT ATRIUM. THE AORTIC RIM WAS ACCEPTABLE IN SIZE (SMALLER THAN 5MM BUT NOT ABSENT). THE POSTERIOR RIM WAS THIN, REDUNDANT AND ANEURYSMAL AND THE IVC AND AV VALVE RIMS WERE ADEQUATE. THE POSTERIOR RIM HAD ANOTHER DEFECT THAT WAS SMALL. THE MAIN DEFECT MEASURED 15MM IN SHORT-AXIS VIEW BEFORE BALLOON SIZING WAS PERFORMED. THE CATHETER WAS SEEN ACROSS THE DEFECT AND THE DEFECT WAS BALLOON SIZED WITH A STOP-FLOW DIAMETER OF 14MM. A 16MM ASO WAS PLACED AND THE MINNESOTA WIGGLE WAS PERFORMED AND THE ASO WAS FOUND TO BE STABLE. THE ASO WAS RELEASED AND BY REPORT, THE ASO EMBOLIZED LATER AND WAS SUCCESSFULLY RETRIEVED. ACCORDING TO AGA'S MEDICAL CONSULTANT, THE FOLLOWING INFERENCES WERE MADE AFTER REVIEWING THE ECHOCARDIOGRAM: AT LEAST TWO DEFECTS WERE NOTED: ONE LARGE MAIN DEFECT OF ABOUT 15MM IN DIAMETER AND A SECOND SMALL DEFECT. THE SECOND DEFECT WAS FAIRLY CLOSE TO THE LARGE DEFECT AND WAS IN THE POSTERIOR ATRIAL SEPTAL RIM. THE CATHETER/SHEATH WAS THROUGH THE SMALLER DEFECT AND THE BALLOON SIZING WAS PERFORMED WHILE THE BALLOON WAS IN THE SMALLER DEFECT. BECAUSE OF THE REDUNDANT NATURE OF THE DEFECT, IT STRETCHED EASILY DURING BALLOON SIZING. BY SLOWLY SCROLLING THROUGH THE ECHO LOOPS, IT WAS EVIDENT THAT THE TRUE WAIST OF THE DEFECT WAS MUCH SMALLER THAN 1.5CM (ORIGINAL ASD SIZE), AND WAS MEASURED TO BE 1.4CM. BECAUSE OF THE MINIMAL DISTANCE BETWEEN THE TWO DEFECTS, THE INFLATED BALLOON NEARLY OCCLUDED THE LARGER DEFECT DUE TO THE HOURGLASS CONFIGURATION. A PIECE OF SHREDDED SEPTUM WAS CLEARLY SEEN AFTER THE SIZING BALLOON WAS REMOVED. AFTER THE DEVICE WAS PLACED IT REMAINED SECURE AS IT WAS IN THE SMALLER DEFECT (THE WAIST OF THE DEPLOYED ASO WAS ABOUT 1CM AND IT SHOULD HAVE BEEN AT LEAST 15 OR 16MM IF THE DEVICE WAS THROUGH THE LARGER DEFECT). AFTER THE ASO WAS RELEASED AND OVER THE COURSE OF TIME, THE THIN SEPTUM BETWEEN THE TWO DEFECTS THAT HAD BEEN PARTIALLY TORN, GAVE IN AND THE TWO DEFECTS BECAME ONE LARGE DEFECT. THIS RESULTED IN DEVICE EMBOLIZATION.

    Additional Manufacturer Narrative · 1

    AGA MEDICAL COULD NOT EVALUATE THE ASO INVOLVED IN THIS INCIDENT SINCE IT WAS NOT RETURNED TO US, BUT DISCARDED AT THE HOSPITAL.

    Description of Event or Problem · 1

    ACCORDING TO THE INITIAL INFORMATION RECEIVED, ON (B)(6) 2010, A 16MM AMPLATZER SEPTAL OCCLUDER (ASO) EMBOLIZED PRIOR TO PATIENT DISCHARGE. THE ASO WAS PERCUTANEOUSLY RETRIEVED FROM THE ABDOMINAL AORTA. ADDITIONAL INFORMATION HAS BEEN REQUESTED, INCLUDING IMAGING OF THE IMPLANT PROCEDURE AND PATIENT AND DEVICE INFORMATION, BUT HAS NOT YET BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZER SEPTAL OCCLUDER CARDIAC OCCLUSION DEVICE MLV AGA MEDICAL CORPORATION 9-ASD-016 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention