BEUDAMED
    FDA Adverse Event Death Summary report: N

    STAPLE, IMPLANTABLE

    MDR report key: 6085612 · Received November 8, 2016

    Report

    Report Number
    3005075853-2016-06379
    Event Type
    Death
    Date Received
    November 8, 2016
    Date of Event
    October 10, 2016
    Report Date
    October 21, 2016
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K110385
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION REQUESTED AND RECEIVED: INDICATION OF THE SURGERY WAS MORBID OBESITY; SLEEVE GASTRECTOMY; LEAK IDENTIFIED AFTER 10 DAYS OF SURGERY; FUNDUS OF STOMACH; NO BUTTRESSING MATERIAL USED; NO IDENTIFIABLE ISSUES IN PRIMARY PROCEDURE APART FROM FEW BLEEDERS, WHICH WAS CONTROLLED BY CLIPPING ON TABLE; CAUSE OF DEATH UNKNOWN, IDENTIFIED AS STAPLE LEAK AT FUNDUS REGION, CAUSE MAY BE THE BOLUS OF FOOD PATIENT HAD; NO IDEA ABOUT AUTOPSY, IF DONE RESULTS SHOULD BE AVAILABLE WITH DR. (B)(6) AND CAN GET THE SAME.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION RECEIVED FROM CALL WITH SURGEON: PER THE SURGEON: THE PATIENT WAS A (B)(6) FEMALE PATIENT. INTRA-OPERATIVELY, A 36 FR BOUGIE WAS USED AND A GST60B CARTRIDGE WAS USED IN THE FUNDUS AREA. THE SLEEVE WAS CREATED USING A COMBINATION OF GREEN AND BLUE GST CARTRIDGES WITH NO BUTTRESSING MATERIAL. THE STAPLE LINES LOOKED GOOD. THE PATIENT WAS DISCHARGED TWO DAYS POST-OPERATIVELY AND WAS UNDER THE CARE OF HER MOTHER. ON POST-OPERATIVE DAY 9, THE PATIENT WENT INTO SHOCK. A CT SCAN REVEALED A LEAK IN THE FUNDUS AREA OF THE SLEEVE. THE PATIENT WAS REOPERATED AND THE 2-3 CENTIMETER LEAK IDENTIFIED AT THE LAST FIRING OF THE SLEEVE WAS OVERSEWN. THE PATIENT PASSED AWAY WITHIN 24 HOURS. THE PATIENT WAS NOT DIABETIC AND HAD NO OTHER CO-MORBID CONDITIONS. HOWEVER, THE PATIENT SUFFERED FROM A GENETIC PROBLEM THAT RESULTED IN OVEREATING WITH NO SATIETY. THE SURGEON IS QUESTIONING WHETHER THE PATIENT COULD HAVE OVEREATEN CAUSING INCREASED PRESSURE ON THE STAPLE LINE. THE MOTHER HAD SAID SHE WAS COMPLIANT; ALTHOUGH, IT IS POSSIBLE THAT THE DAUGHTER COULD HAVE OVEREATEN WHEN THE MOTHER WENT TO PICK UP ANOTHER CHILD. ANOTHER THEORY WAS POSSIBLE ISCHEMIA, HOWEVER, THE SURGEON STATED THAT DURING HIS SLEEVE CASES, HE IS CAREFUL NOT TO OVER DISSECT IN THE AREA OF THE FUNDUS AND HE DOES THE FUNDUS FIRINGS APPROXIMATELY 0.5-1CM FROM THE BOUGIE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER AN UNKNOWN PROCEDURE, A LEAK ON STAPLE LINE IN A YOUNG PATIENT AND PATIENT EXPIRED AFTER TEN DAYS OF SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737086 STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Death GST60B X4, GST60D X1