BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 1003918 · Received February 29, 2008

    Report

    Report Number
    2135147-2007-00044
    Event Type
    Injury
    Date Received
    February 29, 2008
    Date of Event
    July 28, 2007
    Report Date
    September 12, 2008
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    PMA / PMN Number
    P000039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO AGA?S MEDICAL CONSULTANT, THE IMPLANT ECHO FROM 2002 SHOWED TWO AND POSSIBLY THREE DEFECTS, AND SEPTAL TISSUE IS THIN AND MAY NOT BE CAPALE OF HOLDING THE DEVICE. THE DEVICE WAS PLACED, AND A RESIDUAL SHUNT FROM THE SECOND HOLE WAS PRESENT. ECHOS FROM 2002 TO 2003 SHOW THE DEVICE WAS "OK." AN ECHO, TAKEN IN 2007, SHOWED THE DEVICE PERPENDICULAR TO THE ATRIAL SEPTUM. INTRAOPERATIVE PICTURES SHOW THE DEVICE PERPENDICULAR TO THE DEFECT, AND PICTURES POST-REMOVAL SHOW ENDOTHELIALIZATION WITH TISSUE INGROWTH BETWEEN THE DISKS. THE MEDICAL CONSULTANT REPORTED THAT AS THE SECOND DEFECT COULD NOT HAVE OCCLUDED EVEN WITH AGGRESSIVE BALLOON SIZING. THE IDEAL WAY TO CLOSE THIS DEFECT WOULD HAVE BEEN TO ATTEMPT TO PLACE TWO DEVICES. THE THIN SEPTUM DIVIDING THE DEFECTS WOULD HAVE BEEN THE LIMITED FACTOR EVEN WITH THE TWO DEVICE SCENARIO. THIS DEVICE WOULD HAVE EMBOLIZED BUT INSTEAD IT ROTATED OVER THE THIN SEPTUM AND SAT PERPENDICULAR TO THE DEFECT. AS THE DEFECT ESSENTIALLY STAYED OPEN. THE DEVICE DID NOT EMBOLIZED AND RATHER SAT IN THE SEPTUM CLOSE TO THE AV VALVE. OUR INVESTIGATION CONFIRMED THE RETURNED DEVICE WAS SIGNIFICANTLY DEFORMED BECAUSE OF THE PARTIAL DISLODGMENT. THE INCOMPLETE DEVICE ENDOTHELIAL COVERAGE WAS RELATED TO THE BULGING OF THE DISC, WHICH SIGNIFICANTLY REDUCED THE PROCESS OF ENDOTHELIAZATION.

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS REVIEWED BY AGA'S ASD EROSION ADJUDICATION BOARD ON JULY 14, 2008 AND THE FOLLOWING OBSERVATIONS WERE REPORTED: THIS PATIENT DID NOT EXPERIENCE AN EROSION, THE DEVICE WAS MALPOSITIONED ON INITIAL IMPLANT, AND THE PATIENT ALSO HAD A SECOND DEFECT.

    Description of Event or Problem · 1

    THE IMPLANTING PHYSICIAN REPORTED AN EROSION THROUGH THE POSTERIOR WALL OF THE HEART. THIS WAS THE PHYSICIAN?S FIRST IMPLANT WITH A PROCTOR. PICTURES OF THE SURGERY AND THE DEVICE ARE AVAILABLE AND HAVE BEEN REQUESTED. THE PHYSICIAN IS OUT OF THE COUNTRY FOR TWO WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZER SEPTAL OCCLUDER CARDIAC OCCLUSION DEVICE MLV AGA MEDICAL CORPORATION 9-ASD-032 M01G03-14

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention