BEUDAMED
    FDA Adverse Event Death Summary report: N

    EEA

    MDR report key: 8432818 · Received March 19, 2019

    Report

    Report Number
    1219930-2019-01621
    Event Type
    Death
    Date Received
    March 19, 2019
    Date of Event
    April 23, 2014
    Report Date
    March 19, 2019
    Manufacturer
    US SURGICAL PUERTO RICO
    Product Code
    GDW
    UDI-DI
    10884523005530
    PMA / PMN Number
    K062850
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE MINIMALLY INVASIVE OESOPHAGECTOMY: PRELIMINARY RESULTS AFTER INTRODUCTION OF AN INTRATHORACIC ANASTOMOSIS SOURCE DIGESTIVE SURGICAL, 2014 (95-103) DATE OF PUBLICATION: 23 APRIL 2014. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. [PE# (B)(4)].

    Description of Event or Problem · 1

    ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED FROM JANUARY 2011 UNTIL AUGUST 2012, A TOTAL OF 45 OPERABLE PATIENTS WERE SCHEDULED TO UNDERGO MINIMALLY INVASIVE ESOPHAGECTOMY (MIE) WITH INTRATHORACIC ANASTOMOSIS. EIGHTEEN OUT OF THE 45 PATIENTS WERE UNDER GROUP 2 WHEREIN A CIRCULAR STAPLER WAS USED TO CREATE AN INTRATHORACIC ANASTOMOSIS ALONG WITH ITS ANVIL BEING INSERTED THROUGH ONE OF THE PORTS AND SECURED WITH 2 PURSE STRINGS USING THE STITCHING DEVICE AND SUTURE. ONE OF THE PATIENT'S POST-OPERATIVE COURSE COMPLICATED BY CHYLE LEAKAGE, AND THIS WAS MANAGED CONSERVATIVELY WITH TOTAL PARENTERAL FEEDING DURING 6 DAYS. A CONTRAST SWALLOW CT SCAN 4 DAYS POST-OPERATIVELY SHOWED NO SIGNS OF ANASTOMOTIC LEAKAGE. THE PATIENT DIED 25 DAYS AFTER SURGERY OF MASSIVE HEMORRHAGE FROM A GASTRO-AORTIC FISTULA AT THE LEVEL OF THE ANASTOMOSIS REQUIRING EMERGENCY SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227699 EEA STAPLE, IMPLANTABLE GDW US SURGICAL PUERTO RICO EEA28 10884523005530

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death