BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 2212310 · Received August 15, 2011

    Report

    Report Number
    2135147-2011-00105
    Event Type
    Injury
    Date Received
    August 15, 2011
    Date of Event
    June 20, 2011
    Report Date
    July 15, 2011
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    PMA / PMN Number
    P000039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE AMPLATZER SEPTAL OCCLUDER 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 9F TORQVUE 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. ALSO, WE REQUESTED ADDITIONAL INFORMATION INCLUDING IMAGES AND MEDICAL RECORDS; WHEN OUR INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    IMAGING REVIEW: REVIEW OF THE MEDICAL RECORDS AND IMAGES BY AGAS MEDICAL CONSULTANT RESULTED IN THE FOLLOWING FINDINGS: THIS (B)(6) MALE PATIENT UNDERWENT ASO PLACEMENT FOR A LARGE ATRIAL SEPTAL DEFECT (ASD). THE RIGHT ATRIAL DISC COULD NOT BE DEPLOYED PROPERLY DESPITE MULTIPLE ATTEMPTS AND KEPT PROLAPSING INTO THE RIGHT ATRIUM. DURING ONE OF THE ATTEMPTS, IT GOT ENTANGLED INTO THE TRICUSPID VALVE CHORDA AND COULD NOT BE SEPARATED. THE PATIENT WAS REFERRED FOR SURGICAL REMOVAL OF THE DEVICE. ONE CD WAS PROVIDED WHICH CONTAINED TWO FLUOROSCOPIC LOOPS OF THE EMBOLIZED DEVICE. THE DEVICE WAS NOT ATTACHED TO THE DELIVERY CABLE AND APPEARED TO MOVE FREELY IN AND OUT OF THE TRICUSPID VALVE. ALSO RECEIVED WAS A SHORT NOTE FROM THE SURGEON STATING THAT THE SIZE OF THE DEVICE WAS ADEQUATE. IN FACT, AFTER THE PHYSICIAN UNTANGLED AND REMOVED THE DEVICE, HE PLACED THE DEVICE TO CHECK ITS SIZE IN THE ASD AND APPEARED TO SIT WELL. HE FINALLY REMOVED THE DEVICE AND CLOSED THE DEFECT WITH A PERICARDIAL PATCH. IN ADDITION TO THE ABOVE NOTE, TRANS-ESOPHAGEAL ECHOCARDIOGRAM (TEE) STILL IMAGES WERE PROVIDED ILLUSTRATING THE DEFECT BEING MEASURED, THE AV VALVE RIM, SUPERIOR RIM AND THE SVC RIM. TEE INTERPRETATION WAS PROVIDED AS WELL BUT DID NOT CONTRIBUTE TO THE FINDINGS. CONCLUSION ACCORDING TO AGAS MEDICAL CONSULTANT THE FOLLOWING CONCLUSIONS WERE DRAWN: BASED UPON THE LIMITED STILL IMAGES AND FLUORO IMAGES, THE FOLLOWING INFERENCES CAN BE MADE: THE FACT THAT THE DEVICE BECAME ENTANGLED IN THE TRICUSPID VALVE WHEN IT ACCIDENTALLY DETACHED FROM THE CABLE WHILE BEING RETRACTED INTO THE DELIVERY SHEATH IS TYPICALLY OBSERVED WHEN THE DEVICE IS RECAPTURED SEVERAL TIMES. IN ADDITION, WHILE APPLYING CLOCKWISE TORQUE ON THE SHEATH, THE DEVICE MAY BECOME UNSCREWED FROM THE DELIVERY CABLE INADVERTENTLY. THE DEVICE PROLAPSED MOST LIKELY DUE TO THE ABSENCE OF AN IVC RIM AS THIS WAS THE ONLY RIM NOT SHOWN ON THE ECHO STILL IMAGES. THE SVC RIM WAS GENEROUS WHICH IS SUGGESTIVE OF AN INFERIOR ASD.

    Description of Event or Problem · 1

    ACCORDING TO THE INITIAL INFORMATION RECEIVED, A 24MM AMPLATZER SEPTAL OCCLUDER (ASO) WAS ATTEMPTED IN AN (B)(6) YEAR-OLD PATIENT ((B)(6) KG). THE DEFECT WAS SIZED USING A TRANS-ESOPHAGEAL ECHOCARDIOGRAM REVEALING THE FOLLOWING MEASUREMENTS: 20MM ATRIAL SEPTAL DEFECT (SECUNDUM); 13MM INFERIOR RIM; 8.7MM SUPERIOR RIM; 6.8MM ANTERIOR RIM. AFTER THE LEFT ATRIAL (LA) DISC WAS DEPLOYED, THE ASO WAS DRAWN TOWARD THE SEPTUM AND THE LA DISC PROLAPSED THROUGH THE DEFECT. DESPITE REPEATED ATTEMPTS, THE ASO CONTINUED TO PROLAPSE THROUGH THE DEFECT OR SLIP INTO THE RIGHT ATRIUM. DURING THE LAST ATTEMPT, THE ASO EMBOLIZED INTO THE TRICUSPID VALVE AND COULD NOT BE RETRIEVED. THE PATIENT WAS REFERRED FOR SURGERY TO HAVE THE ASO RETRIEVED AND THE DEFECT SURGICALLY CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMPLATZER SEPTAL OCCLUDER CARDIAC OCCLUSION DEVICE MLV AGA MEDICAL CORPORATION 9-ASD-024 1103245000

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Required Intervention