BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 2133379 · Received June 20, 2011

    Report

    Report Number
    2135147-2011-00072
    Event Type
    Injury
    Date Received
    June 20, 2011
    Date of Event
    June 10, 2011
    Report Date
    September 6, 2011
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    PMA / PMN Number
    P000039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGA MEDICAL COULD NOT EVALUATE THE ASO INVOLVED IN THIS INCIDENT SINCE IT WAS DISCARDED BY THE HOSPITAL POST SURGICAL REMOVAL.

    Additional Manufacturer Narrative · 1

    REVIEW OF THE MEDICAL RECORDS AND IMAGES BY AGAS MEDICAL CONSULTANT RESULTED IN THE FOLLOWING FINDINGS: THIS (B)(6) PATIENT UNDERWENT ASO IMPLANTATION FOR A MODERATE-TO-LARGE ASD. THE INITIAL SEVERAL ATTEMPTS WERE WITH AN 18MM ASO. THESE WERE UNSUCCESSFUL AND THE DEVICE WAS REPLACED WITH 22MM ASO. THE PROCEDURE WENT WELL. THE NEXT MORNING, THE ASO WAS FOUND TO HAVE EMBOLIZED INTO THE LEFT ATRIUM (LA). THE PATIENT WAS SENT FOR SURGICAL REMOVAL OF THE ASO AND PATCH CLOSURE OF THE ASD. ONE CD WITH INTRA-PROCEDURE ECHOCARDIOGRAM (TEE) AND FLUOROSCOPY, POST-DEVICE EMBOLIZATION ECHOCARDIOGRAPHY AND POST SURGICAL PATCH CLOSURE OF ASD ECHO PICTURES WERE PROVIDED. THE ECHOCARDIOGRAM WAS OF EXCELLENT QUALITY. THE TEE EVALUATED ALL ATRIAL SEPTAL RIMS. THE ASD WAS OVAL WITH MAXIMUM DIMENSIONS IN THE BICAVAL VIEW AND MINIMAL DIMENSIONS IN THE SHORT-AXIS AORTIC AND 4-CHAMBER VIEWS. THE AORTIC RIM WAS DEFICIENT IN SEVERAL VIEWS, THE SVC, IVC; POSTERIOR AND SUPERIOR RIMS WERE THIN, FLIMSY AND DID NOT APPEAR STRONG ENOUGH TO HOLD AN ASO. THE AV VALVE RIM WAS WITHIN THE NORMAL LIMITS. THE DEFECT WAS MEASURED TO BE ABOUT 18X13 IN. BI-CAVAL AND SHORT-AXIS VIEWS. HOWEVER, IF THE FLIMSY RIMS HAD BEEN INCLUDED, THE DEFECT WAS ABOUT 25MM IN THE BI-CAVAL VIEW AND ABOUT 20MM IN SHORT-AXIS VIEW. THIS WOULD HAVE BEEN CONFIRMED IF BALLOON SIZING HAD BEEN PERFORMED. AN 18MM ASO HENCE WAS VERY SMALL AND HAD TO BE REMOVED. A 22MM ASO APPEARED ADEQUATE FOR THE DEFECT AND AFTER DEPLOYMENT SAT VERY WELL IN THE ATRIAL SEPTUM. IT SANDWICHED ALL THE RIMS WHICH WERE OPTIMALLY INTERROGATED AND RECORDED. THE ONLY RIM THAT WAS NOT SEEN WAS THE CORONARY SINUS RIM. THE CORONARY SINUS WAS SEEN IN ONE VIEW AFTER 22MM DEVICE IMPLANTATION BUT THE CORONARY SINUS RIM WAS NOT SEEN. 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 ECHOCARDIOGRAM WAS OF EXCELLENT QUALITY. THIN, FLIMSY RIMS IN THE AORTIC, SVC, IVC, POSTERIOR AND SUPERIOR LOCATIONS WERE OBSERVED; THE DEFECT WAS MUCH LARGER THAN 18MM. SINCE BALLOON SIZING WAS NOT PERFORMED, IT LED TO SIGNIFICANT DEVICE UNDERSIZING DURING THE FIRST ATTEMPT. ALTHOUGH THE LEFT ATRIAL DISC OF THE 22MM DEVICE WAS ADEQUATE FOR THE DEFECT, THE RIGHT ATRIAL DISC WAS SMALL FOR THE DEFECT AND HENCE THE DEVICE EMBOLIZED INTO THE LEFT ATRIUM.

    Description of Event or Problem · 1

    ACCORDING TO THE INITIAL INFORMATION RECEIVED, THE ATRIAL SEPTAL DEFECT (ASD) WAS INITIALLY SIZED AND AN 18MM AMPLATZER SEPTAL OCCLUDER (ASO) WAS CHOSEN. UPON DEPLOYMENT, THE 18MM ASO WAS DETERMINED TO BE TOO SMALL AND REMOVED. A 22MM ASO WAS SUCCESSFULLY PLACED. ACCORDING TO A SCAN PERFORMED THE NEXT MORNING, THE 22MM ASO WAS NOTED TO HAVE EMBOLIZED TO THE LEFT ATRIUM. THE PATIENT WAS SENT TO SURGERY LATER THAT AFTERNOON FOR SURGICAL REMOVAL OF THE ASO FROM THE LEFT ATRIUM AND ATRIAL SEPTAL 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-022 1007014552

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Required Intervention