BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMPLATZER TORQVUE DELIVERY SYSTEM

    MDR report key: 6131493 · Received November 29, 2016

    Report

    Report Number
    2135147-2016-00120
    Event Type
    Death
    Date Received
    November 29, 2016
    Report Date
    November 11, 2016
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    DQY
    PMA / PMN Number
    K072313
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE REFER TO (B)(4) FOR A RELATED REPORT FOR THE ASO. (B)(4). THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. OUR INVESTIGATION WAS LIMITED TO THE REVIEW OF THE DEVICE HISTORY RECORD, WHICH SHOWED THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED AND INDICATED COMPLETE IN ACCORDANCE WITH SJM SPECIFICATIONS AND PROCEDURES. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    IN EARLY (B)(6) 2016, A 9F AMPLATZER TORQVUE 45 DELIVERY SYSTEM (DTV45) WAS SELECTED TO IMPLANT A 28MM AMPLATZER SEPTAL OCCLUDER (ASO). DURING THE PROCEDURE, HOWEVER, THE ASO WAS NOTED TO HAVE PREMATURELY DETACHED FROM THE DELIVERY CABLE WHILE THE ASO WAS INSIDE THE DELIVERY SHEATH. THIS OBSERVATION WAS NOTED ON X-RAY. MULTIPLE ATTEMPTS WERE MADE TO SNARE THE ASO WHILE IT WAS INSIDE THE DELIVERY SHEATH; HOWEVER, WHEN THE ATTEMPTS WERE UNSUCCESSFUL THE USER ELECTED TO ADVANCE THE ASO THROUGH THE SHEATH INTO THE RIGHT ATRIUM WHERE ADDITIONAL ATTEMPTS WERE MADE TO SNARE THE ASO. PER REPORT, THE ASO EMBOLIZED INTO THE LA OR LAA DUE TO EXCESSIVE MANIPULATION OF BOTH THE SNARE AND THE DTV45 SHEATH. THE DTV45 SHEATH WAS ADVANCED INTO THE LA IN AN ATTEMPT TO RECAPTURE THE DEVICE CAUSING THE ASO TO EMBOLIZE FROM THE INITIAL LOCATION TO THE LV. THE PATIENT BECAME BRADYCARDIC AND ON ECHO, THERE WAS EVIDENCE OF CARDIAC TAMPONADE WHICH WAS SUSPECTED TO HAVE BEEN CAUSED BY EXCESSIVE MANIPULATION OF THE DTV45 SHEATH. DESPITE CPR AND PERICARDIOCENTESIS, THE PATIENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783876 AMPLATZER TORQVUE DELIVERY SYSTEM DELIVERY SYSTEM DQY AGA MEDICAL CORPORATION 9-ITV09F45/80 5410402

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R