BEUDAMED
    FDA Adverse Event Death Summary report: N

    SINGLE USE BILIARY STENT V

    MDR report key: 3875083 · Received June 11, 2014

    Report

    Report Number
    8010047-2014-00304
    Event Type
    Death
    Date Received
    June 11, 2014
    Date of Event
    August 1, 2012
    Report Date
    May 30, 2014
    Manufacturer
    OLYMPUS MEDICAL SYSTEMS CORPORATION
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT STENT WAS NOT RETURNED TO OMSC FOR INVESTIGATION. THE EXACT CAUSE OF THE USER'S EXPERIENCE COULD NOT BE CONCLUSIVELY DETERMINED. THE DOCTOR SAID THAT HE DIDN'T THINK THE PRODUCT PROBLEM. HE THOUGHT THAT THE DUODENAL BEND STENT SHOULDN'T BE PLACED INTO THE PT OVER LONG PERIODS AND IT CAUSED THE STENT MIGRATION. THUS, OMSC CONSIDERS THAT THERE WAS NO PROBLEM IN THE SUBJECT DEVICE. THE PLACEMENT OF THE STENT FOR A LONG TIME CAUSED THE STENT MIGRATION AND BLEEDINGS. THE USER FACILITY REPORTED THAT THEY DIDN'T FIND NEW INTRAHEPATIC BLEEDINGS WITH CT SCAN AFTER THE PT DIED. ACCORDING TO THE REPORT, OMSC THINKS THAT THERE WAS NO CORRELATION BETWEEN THE SUBJECT PRODUCT AND THE PT DEATH. THIS REPORT IS BEING SUBMITTED AS A MEDICAL DEVICE REPORT IN AN ABUNDANCE OF CAUTION.

    Description of Event or Problem · 1

    OLYMPUS MEDICAL SYSTEMS CORP (OMSC) WAS INFORMED THAT THE PT CAME TO THE HOSP DUE TO LOSS OF APPETITE AND BLACK STOOL, AS A RESULT OF CT SCAN, THE DOCTOR FOUND THAT ONE OF TWO STENTS MIGRATED INTO LIVER AND BILIARY BLEEDING WAS SUSPECTED. THE DOCTOR RETRIEVED THE MIGRATED STENT AND INSERTED A DOUBLE LAYER STENT INTO THE PT. AFTER 8 DAYS, THE PT REQUIRED BLOOD TRANSFUSION SINCE SHE BECAME A SHOCK DISEASE AND BLEEDING IN THE RIGHT HEPATIC LOBE OCCURRED. THE DOCTOR PERFORMED ARTERIAL EMBOLIZATION AND SHE BECAME STABLE CONDITION. HOWEVER, AFTER 33 DAYS THE PT DIED OF CARDIOPULMONARY ARREST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343886 SINGLE USE BILIARY STENT V BILIARY STENT FGE OLYMPUS MEDICAL SYSTEMS CORPORATION PBD-V601R-0705

    Patients

    Seq Age Sex Outcome Treatment
    1 98 YR Death