BEUDAMED
    FDA Adverse Event Death Summary report: N

    DENVER SHUNT

    MDR report key: 1333052 · Received December 31, 2008

    Report

    Report Number
    1333052
    Event Type
    Death
    Date Received
    December 31, 2008
    Date of Event
    September 17, 2008
    Report Date
    September 29, 2008
    Manufacturer
    CARDINAL HEALTH
    Product Code
    KPM
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT WAS DIAGNOSED WITH LARGE INFECTED RETROPERITONEAL LYMPHATIC MALFORMATION WITH HYDRONEPHROSIS IN 2008. A PARTIAL RESECTION WAS PERFORMED TWO MONTHS LATER. SHE HAD PERSISTENT CHYLOUS ASCITES UNRESPONSIVE TO MEDICAL MANAGEMENT AND NUMEROUS DRAINAGES OF THE PERITONEAL FLUID. A DENVER SHUNT WAS PLACED TWO MONTH LATER. THE SHUNT INITIALLY WORKED WELL BUT SHE THEN BEGAN ACCUMULATING CHYLOUS ASCITES AGAIN. SHE UNDERWENT DIAGNOSTIC FLUOROSCOPY THE FOLLOWING MONTH, TO DETERMINE IF THE SHUNT NEEDED TO BE REPLACED OR REPAIRED. THE CONTRAST STUDY DEMONSTRATED THAT THE TIP OF THE SHUNT HAD MIGRATED BACK TO THE R BRACHIOCEPHALIC VEIN REGION WITH A FIBRIN SHEATH AROUND THE TIP OF THE CATHETER. DRAINAGE OF THE ASCETIC FLUID WAS INITIATED USING A CLOSED SYSTEM WITH A GLASS SUCTION BOTTLE. DURING THE DRAINAGE, THE PT SUFFERED AN ACUTE AIR EMBOLISM AND EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DENVER SHUNT DENVER SHUNT KPM CARDINAL HEALTH 10443

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Death