BEUDAMED
    FDA Adverse Event Death Summary report: N

    PROLENE POLYPROPYLENE SUTURE

    MDR report key: 3173623 · Received June 17, 2013

    Report

    Report Number
    2210968-2013-07085
    Event Type
    Death
    Date Received
    June 17, 2013
    Date of Event
    March 29, 2013
    Report Date
    May 21, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    GAW
    PMA / PMN Number
    N16374
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THE SUTURE WAS USED FOR CONTINUOUS AND INTERRUPTED SEWING. THE PATIENT¿S SYMPTOM OF HEMORRHAGIC SHOCK WAS A DROP IN PRESSURE. THE PATIENT UNDERWENT AN EMERGENCY RE-OPERATION ON (B)(6) 2013. THE BLEEDING SITE WAS IDENTIFIED IN THE SECOND HEPATIC PORTAL. THE SURGEON SAW THAT THE SUTURE WAS BROKEN. THE SURGEON ALSO SAW THAT THE INTACT SUTURE LINE TORE THROUGH THE VENOUS WALL TISSUE. THE SURGEON USED A CLAMP TO ATTEMPT TO REPAIR THE BLEEDING SITE, BUT THE PATIENT LOST ABOUT 4000CC OF BLOOD. A 4000CC BLOOD TRANSFUSION WAS PERFORMED. THE RE-OPERATION WAS NOT COMPLETED. THE PATIENT DIED DURING THE RE-OPERATION ON (B)(6) 2013 AND THE CAUSE OF DEATH WAS HEMORRHAGIC SHOCK. THE SURGEON OPINES THAT THE SUTURE BREAKAGE WAS A CONTRIBUTING FACTOR TO THE HEMORRHAGIC SHOCK AND PATIENT¿S DEATH. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A RADICAL RESECTION OF HILAR HOLANGIOCARCINOMA AND RIGHT LOBECTOMY OF LIVER ON (B)(6) 2013 AND SUTURE WAS USED ON THE RIGHT HEPATIC VEIN. ON (B)(6) 2013, SIX DAYS AFTER THE OPERATION, THE PATIENT FELT SICK, COUGHED AND HIS ABDOMINAL PRESSURE INCREASED. THEN THE PATIENT WENT INTO HEMORRHAGIC SHOCK. THE SURGEON DID EMERGENCY MEASURES IMMEDIATELY, BUT THE PATIENT DIED ON (B)(6) 2013. ADDITIONAL PATIENT AND EVENT INFO WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273819 PROLENE POLYPROPYLENE SUTURE SUTURE, NON-ABSORBABLE GAW ETHICON, INC. NA EEE108

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death| R