BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDOPATH ETS FLEX45

    MDR report key: 1611860 · Received February 19, 2010

    Report

    Report Number
    3005075853-2010-00719
    Event Type
    Death
    Date Received
    February 19, 2010
    Date of Event
    November 13, 2009
    Report Date
    January 25, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K020779
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4): INFO IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVAL.

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNK PROCEDURE, THE SURGEON TOOK THE INFERIOR MESENTERIC ARTERY WITH THE DEVICE AND THE STAPLE LINE WAS SUCCESSFUL. AT SOME POINT AFTER THE OPERATION, THE STAPLE LINE BEGAN TO BLEED AND THE PT WAS RETURNED TO SURGERY WHERE THE INFERIOR MESENTERIC ARTERY WAS RE-STAPLED THE FOLLOWING DAY BY ANOTHER SURGEON. THE PT LATER EXPERIENCED ACUTE RESPIRATORY DISTRESS SYNDROME AFTER THE PROCEDURE. THE PT THEN SUFFERED A MYOCARDIAL INFARCTION AND EXPIRED. THE DEVICE WAS DISCARDED. ACCORDING TO THE SURGEON, THE BLOOD LOSS OF THE FAILED STAPLE LINE COULD HAVE CAUSED THE PT TO GET ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS) AFTER THE PROCEDURE. THE PT SUFFERED A MYOCARDIAL INFARCTION THAT MAY OR MAY NOT HAVE BEEN CAUSED BY THE ARDS. THERE IS CURRENTLY A (B) (6) AGAINST THE PRIMARY SURGEON. POTENTIAL LOTS WERE PROVIDED AND THE DEVICE HISTORY RECORDS WERE REVIEWED; NO ANOMALIES WERE NOTED DURING THE MANUFACTURER PROCESS.

    Description of Event or Problem · 1

    EES ASSOCIATES SPOKE WITH MR (B) (4). HE INDICATED DURING THE INITIAL PROCEDURE EVERYTHING LOOKED FINE. HE EXPLAINED THAT HE CHECKS EVERY STAPLE LINE AFTER FIRING AND NOTED NO ABNORMALITIES. ANOTHER COLORECTAL SURGEON WAS ALSO PRESENT FOR THE CASE AND OBSERVED NO ISSUES EITHER. APPROXIMATELY 12-15 HOURS POST OP THE PATIENT RETURNED WITH BLEEDING FROM THE STAPLE LINE AND THE COLORECTAL SURGEON WHO OPERATED WITH HIM THE DAY BEFORE WAS ON CALL AND REOPERATED ON THIS PATIENT. THIS SURGEON ADVISED MR (B) (4) THAT AT REOP, THE PELVIS WAS FULL OF BLOOD; THE PATIENT WAS SUCTION ¿PULSATILE BLEEDING¿ WAS OBSERVED AT THE STAPLE LINE. PATIENT RECEIVED 4 UNITS OF BLOOD; HEMOGLOBIN WAS 7. ANOTHER ATW35 WAS USED TO FIRE PROXIMAL TO THE INITIAL STAPLE LINE. THIS STAPLE LINE LOOKED GOOD AND THE PATIENT WAS CLOSED. PATIENT WAS DESCRIBED AS BEING MALNOURISHED, ALBUMIN WAS 31. SINCE THE 2ND PROCEDURE THE PATIENT WAS SLOWLY PROGRESSING, APPROXIMATELY 3 WEEKS LATER PATIENT EXHIBITED PULMONARY EDEMA AND DEVELOPED ADULT RESPIRATORY DISTRESS SYNDROME AND CARDIAC FAILURE AND WAS PLACED ON A VENTILATOR. FIVE WEEKS LATER THE PATIENT DIED OF AN ACUTE CARDIAC EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOPATH ETS FLEX45 GDW STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death