BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZER TORQVUE 45 DELIVERY SYSTEM

    MDR report key: 4261086 · Received November 19, 2014

    Report

    Report Number
    2135147-2014-00116
    Event Type
    Injury
    Date Received
    November 19, 2014
    Date of Event
    November 29, 2010
    Report Date
    October 20, 2014
    Manufacturer
    AGA MEDICAL CORPORATION
    Product Code
    DQY
    PMA / PMN Number
    PK072313
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SJM COULD NOT EVALUATE THE DTV45 INVOLVED IN THIS INCIDENT SINCE IT WAS NOT RETURNED TO US. THE DELIVERY SYSTEM¿S MANUFACTURING RECORDS COULD NOT BE REVIEWED SINCE THE LOT NUMBER FOR THE AFFECTED PRODUCT WAS NOT PROVIDED TO SJM. THE CAUSE OF THE REPORTED EVENT REMAINS UNKNOWN.

    Description of Event or Problem · 1

    DURING A PFO PROCEDURE WHEN A 9F AMPLATZER TORQVUE 45 DELIVERY SYSTEM (DTV45) WAS PLACED, AN AIR EMBOLISM OCCURRED. THIS AIR EMBOLISM LED TO HYPOXIC BRAIN DAMAGE AND MEDIA INFARCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    750064 AMPLATZER TORQVUE 45 DELIVERY SYSTEM DELIVERY SYSTEM DQY AGA MEDICAL CORPORATION 9-ITV09F45/80

    Patients

    Seq Age Sex Outcome Treatment
    1 Other