BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 1012558 · Received March 15, 2008

    Report

    Report Number
    2135147-2008-00018
    Event Type
    Injury
    Date Received
    March 15, 2008
    Date of Event
    February 11, 2008
    Report Date
    April 21, 2008
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    PMA / PMN Number
    P000039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED FOR ANALYSIS. ECHOCARDIOGRAPHIC IMAGES WERE PROVIDED TO AGA'S CONSULTING PHYSICIAN. THE CONSULTING PHYSICIAN OBSERVED THAT THE PATIENT'S RIMS WERE LIKELY MISSING OR DEFICIENT, AND THE SIZING PERFORMED DETERMINED DID NOT COMPLETELY STOP FLOW THROUGH THE SEPTAL DEFECT. THE PHYSICIAN COULD HAVE USED 22MM OR 24MM DEVICES.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED AT AGA IN THE 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. A DHR SEARCH WAS PERFORMED DOWN TO THE FORMING LEVEL, AND ALL PASSED DEVICE MET SPECIFICATIONS.THE IMAGING OF THE PROCEDURE WAS REVIEWED BY AGA?S MEDICAL CONSULTANT AND THE FOLLOWING OBSERVATIONS WERE REPORTED: THIS PATIENT EXPERIENCED DEVICE EMBOLIZATION IMMEDIATELY AFTER RELEASE FROM THE CABLE. THE DEVICE WAS SUCCESSFULLY REMOVED PERCUTANEOUSLY. THE DEFECT ASSESSMENT SHOWS A DEFICIENT AORTIC RIM. THE SUPERIOR RIM WAS THIN AND FLIMSY AND FLUTTERS WITH THE ATRIAL CYCLE. THE TRUE ATRIAL SEPTUM (SEPTUM THAT CAN HOLD THE DEVICE) WAS ABOUT 19-22 MM IN DIAMETER AND IN SOME VIEWS MAY BE LARGER. BALLOON SIZING WAS PERFORMED AND THE WAIST WAS SEEN TOWARDS THE POSTERIOR SEPTUM. THE STOP-FLOW DIAMETER TOWARD THE AORTIC RIM SIDE WAS NOT ACHIEVED. THE OUTER SIDE OF THE LEFT DISC AFTER DEPLOYMENT FACED THE AORTA, INDICATING THAT THE AORTIC RIM WAS NOT ABSENT AND THE DISC DID NOT PROLAPSE INTO THE RIGHT ATRIUM. BECAUSE OF THE RELATIVE SMALL SIZE OF THE DEVICE, THE LEFT DISC PULLED INTO THE AREA OF THE ATRIAL SEPTUM. AS THE POSTERIOR RIM WAS THIN, THE DEVICE WAS RELATIVELY UNDERSIZED, DID NOT AFFIX TO THE DEFECT, AND EMBOLIZED INTO THE LEFT ATRIUM.

    Description of Event or Problem · 1

    A PHYSICIAN ATTEMPTED IMPLANT OF A 16MM ASD. THE DEVICE WAS MIS-SIZED AND REMOVED. THE PHYSICIAN THEN ATTEMPTED AN 18MM DEVICE. AFTER SEATING THE SECOND DEVICE, EVERYTHING LOOKED GOOD ON ECHO AND FLOURO BUT WHEN RELEASED FROM THE CABLE, IT EMBOLIZED INTO THE LA. A 12F BAIL-OUT SHEATH WAS UNSUCCESSFULLY IN RETRIEVAL. SNARES WERE UTILIZED AND THE DEVICE WAS REMOVED FROM THE BODY. THE PATIENT WAS TAKEN TO PAW AND WATCHED OVERNIGHT. SURGERY WILL BE PERFORMED TO CLOSE THE ASD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZER SEPTAL OCCLUDER CARDIAC OCCLUSION DEVICE MLV AGA MEDICAL CORPORATION 9-ASD-0 M06E16-37

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Required Intervention