BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 2083471 · Received May 10, 2011

    Report

    Report Number
    2135147-2011-00041
    Event Type
    Injury
    Date Received
    May 10, 2011
    Date of Event
    December 15, 2010
    Report Date
    August 16, 2011
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    PMA / PMN Number
    P000039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 PATIENT UNDERWENT ASD CLOSURE. THE DEFECT WAS 4MM AND AN 8MM ASO WAS PLACED BUT EMBOLIZED. NO TIME SPECIFICATION AS TO WHEN THE ASO EMBOLIZED WAS PROVIDED. ONE CD WITH ANGIOS OF ASO IN PLACE WITH PULL-PUSH MANEUVERS WAS PROVIDED. NO ECHO IMAGES WERE PROVIDED. 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 LOADER WITHOUT ANY DEFORMITIES. 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. ACCORDING TO AGAS MEDICAL CONSULTANT THE FOLLOWING CONCLUSIONS WERE DRAWN: THE FLUOROSCOPIC IMAGES DID NOT PROVIDE ANY INFORMATION AS TO THE CAUSE OF ASO EMBOLIZATION. WE NEED COPIES OF THE ECHOCARDIOGRAM TAKEN DURING DEVICE PLACEMENT TO DETERMINE THE REASON FOR EMBOLIZATION. IT IS VERY UNLIKELY THE 8MM ASO WAS TWICE THE DIAMETER OF THE 4MM DEFECT TO EMBOLIZE UNLESS IT DID NOT SANDWICH THE RIMS OR THE DEFECT WAS CLASSIFIED AS A PFO.

    Description of Event or Problem · 1

    ACCORDING TO THE INITIAL INFORMATION RECEIVED, THE PATIENT EXPERIENCED PULMONARY HYPERTENSION AFTER IMPLANT AND THE 8MM AMPLATZER SEPTAL OCCLUDER (ASO) WAS NOTED TO HAVE EMBOLIZED PER THE ECHOCARDIOGRAM. THE PATIENT WAS SENT TO SURGERY FOR ASO RETRIEVAL AND DEFECT CLOSURE. 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-008 M07M04-12

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Required Intervention