BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 1247107 · Received December 2, 2008

    Report

    Report Number
    2135147-2008-00115
    Event Type
    Injury
    Date Received
    December 2, 2008
    Date of Event
    March 2, 2006
    Report Date
    December 2, 2008
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    PMA / PMN Number
    P000039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGA MEDICAL CONTACTED THE AUTHOR OF THIS ARTICLE AND NO ADDITIONAL INFORMATION HAS BEEN PROVIDED REGARDING THIS EVENT, INCLUDING PATIENT AND DEVICE INFORMATION. THE RESULTS OF THIS INVESTIGATION ARE INCONCLUSIVE SINCE THE IMPLANT ECHOCARDIOGRAMS OR MEDICAL RECORDS WERE NOT PROVIDED TO AGA MEDICAL FOR REVIEW. ECHOCARDIOGRAMS ARE NEEDED TO CONFIRM SIZING AND EVALUATE OTHER PARAMETERS OF THE IMPLANT PROCEDURE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, AGA MEDICAL WILL FILE A SUPPLEMENT REPORT. THE ARTICLE IS ATTACHED TO THIS REPORT. - ATTACHMENT: [A 1044.PDF]

    Description of Event or Problem · 1

    BETWEEN 2003 AND 2007, TOTAL PATIENTS WITH SECUNDUM TYPE ATRIAL SEPTAL DEFECTS (ASD) UNDERWENT ATTEMPTED TRANSCATHETER CLOSURE WITH THE AMPLATZER SEPTAL OCCLUDER (ASO). THERE WERE SOME PATIENTS IN THIS STUDY IN WHOM THE PROCEDURE FAILED. IN THE TWO PEDIATRIC PATIENTS, THE ASD WAS CONSIDERED LARGE FOR THEIR AGE. THE REASON FOR FAILURE WAS DUE TO A SMALL LEFT ATRIAL CAPACITY IN WHICH THE LEFT ATRIAL DISC WAS UNABLE TO EXPAND FULLY. THESE DEVICES WERE NOT RELEASED FROM THE CABLE, THEREFORE, MEDWATCH REPORTS WERE NOT SUBMITTED.IN THE FOUR ADULT PATIENTS IN WHICH THE PROCEDURE FAILED, THE REASONS FOR FAILURE WERE: 1. A LARGE ASD AND THE ASO PROLAPSED INTO THE RIGHT ATRIUM; THIS DEVICE WAS NOT RELEASED FROM THE CABLE. THIS DEVICE WAS NOT RELEASED FROM THE CABLE, THEREFORE, A MEDWATCH WAS NOT SUBMITTED.2. A VERY THIN INTERATRIAL SEPTUM THAT WAS TORN BY THE ASO WHILE THE LEFT ATRIAL DISC WAS PULLED FROM THE LEFT ATRIUM INTO THE RIGHT ATRIUM, INCREASING THE DIAMETER FROM 25MM TO 39MM. (MEDWATCH REPORT # 2135147-2008-00115)3. ASO MIGRATED TO THE RIGHT VENTRICLE IMMEDIATELY. THE ASD SIZE MEASURED BY TEE WAS 36MM AND THE PATIENT HAD VIGOROUS COUGH THAT LED TO ASO DISLODGMENT IMMEDIATELY AFTER RECOVERY FROM GENERAL ANESTHESIA. (MEDWATCH REPORT # 2135147-2008-00136)4. ASO MIGRATED TO THE RIGHT VENTRICLE THE FOLLOWING DAY. THE ASD SIZE MEASURED DURING THE OPERATION WAS 45X25MM, WHICH WAS LARGER THAN THAT MEASURED BY TEE (34MM) IN THE CATHETERIZATION ROOM, AND THUS ASO DISLODGMENT WAS DUE TO THE UNDERESTIMATION OF ASD SIZE. (MEDWATCH REPORT # 2135147-2008-00137)

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention