BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 2133755 · Received June 20, 2011

    Report

    Report Number
    2135147-2011-00082
    Event Type
    Injury
    Date Received
    June 20, 2011
    Date of Event
    June 10, 2011
    Report Date
    September 20, 2011
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    PMA / PMN Number
    P000039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE MEDICAL RECORDS AND IMAGES BY AGAS MEDICAL CONSULTANT RESULTED IN THE FOLLOWING FINDINGS: THIS (B)(6) MALE WAS FOUND TO HAVE AN ATRIAL LEVEL COMMUNICATION. HE UNDERWENT ASO PLACEMENT AFTER BALLOON SIZING. AFTER RELEASE, THE DEVICE EMBOLIZED TO THE AORTA. IT WAS SUCCESSFULLY SNARED AND REMOVED. A 30 MM PFO OCCLUDER WAS PLACED WITHOUT ANY ADDITIONAL COMPLICATIONS. TWO CDS WERE PROVIDED FOR REVIEW. ONE CD HAD FLUOROSCOPIC IMAGES OF BALLOON SIZING, EMBOLIZED DEVICE AND DEVICE RETRIEVAL. THE RETRIEVAL WAS FOLLOWED BY PLACEMENT OF AMPLATZER PFO AND APPEARED TO BE STABLE. THE 2ND CD HAD FEW ECHOCARDIOGRAPHIC IMAGES OF THE ATRIAL SEPTAL ANATOMY PRIMARILY. NO ECHO IMAGES OF THE INITIAL DEVICE PLACEMENT OR THE PFO DEVICE PLACEMENT WERE PROVIDED. DURING MANUFACTURING, THIS DEVICE UNDERWENT A SERIES OF INSPECTIONS, INCLUDING VERIFICATION OF DEVICE SIZING. REVIEW OF MANUFACTURING DOCUMENTATION CONFIRMED THIS DEVICE SUCCESSFULLY PASSED THESE INSPECTIONS. ACCORDING TO AGAS MEDICAL CONSULTANT THE FOLLOWING CONCLUSIONS WERE DRAWN: THE ECHO IMAGES SHOWED ATRIAL SEPTAL RIMS IN SHORT AXIS VIEW. THE AORTIC RIM WAS ADEQUATE; THE POSTERIOR RIM WAS THIN AND FLAILING. THE POSTERIOR RIM (SEPTUM PRIMUM) PARTIALLY OVERLAPPED THE AORTIC RIM. THERE WAS SEPARATION BETWEEN THESE RIMS WHICH CONSTITUTED AN ATRIAL LEVEL COMMUNICATION. HOWEVER, ANATOMICALLY, THE DEFECT WAS A PATULOUS PFO WITH THIN POSTERIOR RIM, AND THE OPENING WAS TYPICAL OF A SLIT LIKE OPENING TYPICAL OF PFO. THE ASO WITH SMALLER RIGHT ATRIAL DISC DID NOT OVERLAP THE LIMBUS AND HENCE, EMBOLIZED INTO THE LEFT ATRIUM AND TO THE AORTA. A PFO DEVICE WAS IDEAL FOR THIS PATULOUS PFO WITH THIN POSTERIOR RIMS. THE 30MM PFO WAS THE CORRECT SIZE FOR THIS DEFECT. THE PRIMARY CAUSE OF EMBOLIZATION WAS INCORRECT SELECTION OF THE ASO.

    Description of Event or Problem · 1

    ACCORDING TO THE INITIAL INFORMATION RECEIVED, THE ATRIAL SEPTAL DEFECT WAS SIZED WITH A SIZING BALLOON AND ECHOCARDIOGRAM WITH A MEASUREMENT OF 13.5MM. A 14MM AMPLATZER SEPTAL OCCLUDER (ASO) WAS DEPLOYED, THE POSITION WAS VERIFIED BY X-RAY AND ECHOCARDIOGRAM AND THE ASO WAS RELEASED. THE ASO MOVED AND EMBOLIZED TO THE AORTA. THE ASO WAS PERCUTANEOUSLY RETRIEVED WITH A 14F SNARE. A 30MM AMPLATZER PFO OCCLUDER WAS SUCCESSFULLY IMPLANTED. THE PATIENT WAS NOTED TO BE STABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, INCLUDING IMAGING OF THE IMPLANT PROCEDURE, 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-014 1102173546

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention