BEUDAMED
    FDA Adverse Event Death Summary report: N

    EEA ORVIL

    MDR report key: 8423136 · Received March 14, 2019

    Report

    Report Number
    1219930-2019-01534
    Event Type
    Death
    Date Received
    March 14, 2019
    Date of Event
    April 23, 2014
    Report Date
    March 14, 2019
    Manufacturer
    COVIDIEN LP LLC NORTH HAVEN
    Product Code
    GDW
    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

    (B)(4). TITLE MINIMALLY INVASIVE OESOPHAGECTOMY: PRELIMINARY RESULTS AFTER INTRODUCTION OF AN INTRATHORACIC ANASTOMOSIS SOURCE DIGESTIVE SURGICAL, VOLUME 31, 2014 (95-103) DATE OF PUBLICATION: 23 APRIL 2014. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED, A TOTAL OF 45 OPERABLE PATIENTS WERE SCHEDULED TO UNDERGO MINIMALLY INVASIVE ESOP HAGECTOMY (MIE) WITH INTRATHORACIC ANASTOMOSIS. NINE OF THE 45 PATIENTS WERE UNDER GROUP 1 WHEREIN A CIRCULAR STAPLER WITH AN ORAL ANVIL WAS USED TO CREATE THE INTRATHORACIC ANASTOMOSIS. ONE OF THE FOUR PATIENTS WHO HAD AN ANASTOMOTIC LEAK POST OPERATIVELY, DIED 14 DAYS AFTER THE SURGERY FROM SEPSIS, MYOCARDIAL INFARCTION AND A MAJOR STROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214111 EEA ORVIL STAPLE, IMPLANTABLE GDW COVIDIEN LP LLC NORTH HAVEN EEAORVIL25

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death