BEUDAMED
    FDA Adverse Event Death Summary report: N

    ADVANTAGE SLING SYSTEM

    MDR report key: 1080874 · Received July 23, 2008

    Report

    Report Number
    3005099803-2008-01246
    Event Type
    Death
    Date Received
    July 23, 2008
    Date of Event
    June 20, 2008
    Report Date
    June 23, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FTL
    PMA / PMN Number
    K020110
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC THAT AN ADVANTAGE MID-URETHERAL SLING WAS IMPLANTED; THE SLING PLACEMENT WENT SMOOTH AND THE PT WAS SENT HOME. THE FOLLOWING DAY THE PT RETURNED TO THE HOSP, PRESENTED WITH SEVERE ABDOMINAL PAIN. A GENERAL SURGEON WAS CALLED IN AND EMERGENCY SURGERY WAS PERFORMED. THE PHYSICIAN UNKNOWINGLY PIERCED THE SMALL BOWEL WITH THE TROCAR DURING THE PROCEDURE THE DAY BEFORE. THE GENERAL SURGEON ATTEMPTED TO REPAIR THE SMALL BOWEL PERFORATION. THE GENERAL SURGEON NOTED SEVERE SMALL BOWEL ADHESIONS AND AN ABNORMAL BOWEL LOCATION. THE ADHESION WAS LOCATED HIGH NEAR THE ABDOMINAL WALL/TOP OF THE PUBIC BONE. ADDITIONALLY, THE PT PRESENTED WITH A FRACTURE OF THE PUBLIC BONE. PHYSICIAN STATED NOT SURE IF IT HAPPENED DURING THE SURGERY. THE PT STAYED OVERNIGHT AT THE HOSP AND EXPIRED THE NEXT DAY. THE PHYSICIAN BELIEVES THE PERFORATED BOWEL CAUSED SEPSIS AND NECROTIZING FASCIITIS AND THIS IS WHAT CAUSED THE PT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANTAGE SLING SYSTEM FTL BOSTON SCIENTIFIC CORPORATION M006850200051 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death| R