BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER SEPTAL OCCLUDER

    MDR report key: 2911315 · Received January 11, 2013

    Report

    Report Number
    2135147-2012-00199
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    December 26, 2012
    Report Date
    December 26, 2012
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    MLV
    PMA / PMN Number
    P000039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN ADDITIONAL 5000 UNITS OF HEPARIN WERE ADMINISTERED. AFTER REATTEMPTING ANOTHER 26MM ASO THEN A 30MM ASO, A 28MM ASO WAS SUCCESSFULLY IMPLANTED. ANALYSIS: THE ASO WAS RETURNED TO SJM WITH THE MALE TVFX CORE WIRE SCREW ATTACHED TO THE ASO'S FEMALE SCREW. 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 INTO AND DEPLOYED FROM A TEST LOADER WITHOUT ANY DEFORMITIES. THE DEVICE WAS RETURNED WITHIN SPECIFICATIONS. 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.

    Description of Event or Problem · 1

    A 10F AMPLATZER TORQVUE FX (TVFX) WAS USED TO DELIVER A 26MM AMPLATZER SEPTAL OCCLUDER (ASO). AS THE 26MM ASO WAS BEING RECAPTURED IN AN EFFORT TO UPSIZE TO A LARGER DEVICE, THE TVFX'S CORE WIRE END SCREW BROKE DURING RECAPTURE CAUSING THE ASO TO EMBOLIZE INTO THE LEFT ATRIUM. THE ASO, WITH THE BROKEN WIRE INTACT, WAS SNARED INTO THE IVC WHERE THE ASO WAS RECAPTURED USING A 16F SHEATH. A 28MM ASO WAS SUCCESSFULLY IMPLANTED AND THE PATIENT IS DOING WELL. THE PHYSICIAN RELATES THE BROKEN CORE WIRE TO THE FACT THAT HE OVERTIGHTENED THE ASO ONTO THE WIRE. PLEASE REFERENCE 2135147-2012-00201 ((B)(4)) FOR A RELATED MEDWATCH FOR THE TVFX DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19141 AMPLATZER SEPTAL OCCLUDER CARDIAC OCCLUSION DEVICE MLV AGA MEDICAL CORPORATION 9-ASD-026 1107139329

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Hospitalization