BEUDAMED
    FDA Adverse Event Death Summary report: N

    SEPRAFILM ADHESION BARRIER

    MDR report key: 531262 · Received June 23, 2004

    Report

    Report Number
    1220423-2004-00013
    Event Type
    Death
    Date Received
    June 23, 2004
    Date of Event
    November 15, 2003
    Report Date
    June 23, 2004
    Manufacturer
    GENZYME BIOSURGERY
    Product Code
    MCN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    INFO WAS RECEIVED IN 05/2004 FROM A PATIENT'S PHYSICIAN VIA DISTRIBUTOR REGARDING A PT WITH A MEDICAL HISTORY OF DISSEMINATED CANCER TO THE PERITONEUM. IN 11/2003, AN INTRAVENOUS HYPERALIMENTATION WAS PLACED. THE PT UNDERWENT SURGERY "OF THE PYLORUS SIDE OF GASTRECTOMY" SIX DAYS LATER. AFTER RESECTING THE GASTRIC CANCER, A DRAIN WAS PLACED AND THE GASTER WAS ANASTOMOSED BY SUTURING APPARATUS. ONE SHEET OF SEPRAFILM WAS PLACED UNDER THE MEDIAN ABDOMINAL INCISION. THERE WAS NO SEPRAFILM PLACED ON THE ANASTOMOSIS. THE PERITONEUM WAS SUTURED AND THE SKIN WAS SUTURED BY HAND. THE OPERATION TOOK 4 HOURS. DRAINAGE WAS DONE AFTER THE OPERATION. THE ESTIMATED BLOOD LOSS WAS 594 GRAMS WITHOUT TRANSFUSION. AFTER THE OPERATION, FLOMOXEF SODIUM WAS STARTED FOR POST-OPERATIVE INFECTION PROPHYLAXIS. TWO DAYS AFTER, THE PT HAD A WBC OF 21,000/MM^3 AND THE NEXT DAY, A WBC OF 18,100/MM^3 AND A CRP OF 30.1 MG/L, SUBILEUS AND PLEURAL EFFUSION. THE FOLLOWING DAY, CT SCAN OF THE ABDOMEN REVEALED A FLUID COLLECTION IN THE ABDOMEN AND A DRAIN WAS PLACED IN THE MEDIAN INCISION. THE DAY AFTER, RE-CELIOTOMY WAS PERFORMED FOR ENTEROSTOMY AND PERITONEAL DRAINAGE. THIS REVEALED AN ANASTOMOTIC LEAK OF THE DUODENAL STAMP. THE SEPRAFILM HAD TURNED TO SLUDGE AND WAS REMOVED. AFTER THE OPERATION, THE PT BEGAN TO RECOVER. IN SAME DAY, THE PT WAS STARTED ON FREEZE-DRIED SULFONATED HUMAN NORMAL IMMUNOGLOBULIN FOR SEPSIS, OCTREOTIDE ACETATE FOR PANCREATITIS, ULINASTATIN FOR CARDIOVASCULAR FAILURE AND IMIPENEM CILASTATION FOR INFECTION. FOUR DAYS LATER, THE SPLENIC ARTERY WAS FOUND TO BE BLEEDING. THE PT WAS TREATED WITH HEMOSTASIS, IRRIGATION AND ANGIORRHAPY. ONE WEEK LATER, THE SPLENIC ARTERY WAS AGAIN FOUND TO BE BLEEDING, WHICH WAS TREATED WITH COMPRESSION AND TRANSCATHETER ARTERIAL EMBOLIZATION. IN 12/2003, THE GAUZE WAS REMOVED. IN 12/2003, THE PT EXPERIENCED A RE-OCCURRENCE OF BLEEDING FROM THE SPLENIC ARTERY. THE PT DIED IN 12/2003. THE RELATIONSHIP BETWEEN THE EVENTS AND SEPRAFILM WAS CONSIDERED UNLIKELY, PER THE REPORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEPRAFILM ADHESION BARRIER RESORBABLE ADHESION BARRIER MCN GENZYME BIOSURGERY UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death| R