BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER® SEPTAL OCCLUDER

    MDR report key: 1913708 · Received December 3, 2010

    Report

    Report Number
    2135147-2010-00172
    Event Type
    Injury
    Date Received
    December 3, 2010
    Date of Event
    October 30, 2010
    Report Date
    May 27, 2011
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    PMA / PMN Number
    P000039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS REVIEWED BY AGA MEDICAL EROSION BOARD CHAIR ON (B)(6) 2011 AND DEFINITE EROSION WAS CONFIRMED.

    Additional Manufacturer Narrative · 1

    REVIEW OF THE MEDICAL RECORDS AND IMAGES BY AGAS MEDICAL CONSULTANT RESULTED IN THE FOLLOWING FINDINGS: THIS (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT ASO PLACEMENT FOR A SECUNDUM ASD. THE PROCEDURE WAS UNEVENTFUL. SHE WAS READMITTED ELEVEN (11) DAYS LATER WITH CARDIAC TAMPONADE. PERICARDIOCENTESIS WAS PERFORMED AND BLOODY PERICARDIAL FLUID WAS REMOVED. AFTER THE CHEST WAS OPENED, A PERFORATION AT THE ROOF OF THE LEFT ATRIUM WAS SEEN. THE ASO WAS EXPLANTED, THE DEFECTS IN THE ATRIAL SEPTUM WERE CLOSED (ASD AND PFO) AND THE LEFT ATRIAL ROOF WAS REPAIRED. ONE CD WAS PROVIDED. THIS CD DID NOT PROVIDE ANY MEANINGFUL INFORMATION. IT SHOWED FLUOROSCOPY OF BALLOON SIZING AND DEVICE PLACEMENT. ECHOCARDIOGRAPHIC IMAGES AND SURGEONS NOTE WOULD BE VERY HELPFUL, ESPECIALLY THE ECHOCARDIOGRAM PERFORMED DURING THE PROCEDURE. THE ASO WAS RECEIVED IN ITS ORIGINAL CONFIGURATION WITH FLAT DISCS. THE DEVICE SURFACE (BOTH RIGHT AND LEFT DISCS) WAS PARTIALLY COVERED BY THIN LAYER OF FIBRIN. THE DEVICE WAS MEASURED AND THE SIZE WAS CONFIRMED TO MEET THE 19MM ASO DIMENSIONAL SPECIFICATIONS. ALL THE PATCHES AND SEWING THREADS WERE INTACT AND NO BROKEN WIRES WERE DETECTED. THERE WERE NO ABNORMALITIES NOTED WITH THE RETURNED DEVICE. 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 DESCRIPTION OF THE EVENT AND THE LOCATION OF THE PERFORATION ARE HIGHLY SUGGESTIVE OF DEVICE-RELATED PERFORATION. WITHOUT THE AVAILABILITY OF PRE-PROCEDURE OR INTRA-PROCEDURE ECHOCARDIOGRAM, NO DETERMINATION CAN BE MADE REGARDING DEVICE SIZE SELECTION, APPROPRIATE BALLOON SIZING OR THE TYPE OF DEFECT (HIGH RISK). ALTHOUGH THERE WAS INSUFFICIENT INFORMATION (OPERATIVE REPORT), THIS EVENT CAN BE CONSIDERED A DEVICE-RELATED PERFORATION BASED ON THE SITE OF THE PERFORATION, WHICH IS VERY TYPICAL OF ALL PREVIOUSLY DESCRIBED DEVICE-RELATED PERFORATIONS.

    Description of Event or Problem · 1

    THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH CARDIAC TAMPONADE ELEVEN (11) DAYS POST IMPLANT OF AN AMPLATZER SEPTAL OCCLUDER (ASO). PERICARDIAL CAVITY PUNCTURE WAS PERFORMED IN THE OR AND BLOOD WAS DETECTED. URGENT OPEN HEART SURGERY WAS PERFORMED AND A PERFORATION OF THE LEFT ATRIUM WITH THE LA DISC WAS OBSERVED. THE ASO WAS REMOVED AND THE ASD AND PFO WERE CLOSED AND LA PLASTY WAS PERFORMED. THE INITIAL DEFECT HAD AN ELONGATED NARROW CONFIGURATION THAT EXPANDED FROM THE AORTA TO THE SVC. THE AORTIC RIM WAS ABSENT AND THE SVC RIM WAS MARGINAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZER® SEPTAL OCCLUDER CARDIAC OCCLUSION DEVICE MLV AGA MEDICAL CORPORATION 9-ASD-019 0912107578

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Required Intervention