BEUDAMED
    FDA Adverse Event Death Summary report: N

    ECHELON*FLEX60 COMPACT

    MDR report key: 2213918 · Received August 17, 2011

    Report

    Report Number
    3005075853-2011-03333
    Event Type
    Death
    Date Received
    August 17, 2011
    Date of Event
    July 22, 2011
    Report Date
    July 26, 2011
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K081146
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT: (B)(4) 2011. INFORMATION WAS NOT PROVIDED BY THE INITIAL CONTACT. INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PNEUMONECTOMY PROCEDURE, A VAT DISSECTION WAS DONE OF THE LEFT INFERIOR PULMONARY VEIN. A FEW MINUTES AFTER THE DOCTOR STAPLED AND DIVIDED THE VEIN PROXIMALLY INCORPORATING CARDIAC MUSCLES; THERE WAS A SUDDEN GUSH OF BLOOD. PRESSURE WAS APPLIED TO CONTROL THE BLEEDING AND THE CHEST WAS OPENED AND EXPLORED, THE BLEEDING SEEMED TO STOP FOR A FEW MINUTES THEN IT STARTED AGAIN. THE MORE PRESSURE WAS APPLIED, THE MORE BLEEDING WORSENED. AFTER 45 MINUTES OF TRYING TO CONTROL THE BLEEDING, THE PATIENT DIED, AND THE WHOLE STAPLE LINE DEHISCED. ADDITIONAL FOLLOWUP: DEVICE WAS DISCARDED BY HOSPITAL. THE RELOAD USED WAS WHITE. NO AUTOPSY OR X-RAY OR VIDEO IS AVAILABLE. LOT NUMBER IS UNKNOWN. ADDITIONAL DETAIL HAS BEEN REQUESTED, NO RESPONSE HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECHELON*FLEX60 COMPACT STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death