BEUDAMED
    FDA Adverse Event Death Summary report: N

    G2 FILTER SYSTEM FEMORAL

    MDR report key: 1053107 · Received May 28, 2008

    Report

    Report Number
    2020394-2008-00145
    Event Type
    Death
    Date Received
    May 28, 2008
    Report Date
    May 7, 2008
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K062887
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED, AS THE LOT NUMBER WAS UNK. THE SAMPLE WAS NOT RETURNED FOR EVAL, SO A SAMPLE EVAL COULD NOT BE PERFORMED. BASED ON THE INFO RECEIVED, THE RESULTS ARE INCONCLUSIVE AND THE ROOT CAUSE OF THE EVENT IS UNK. THE CURRENT IFU (INFO FOR USE) FOR THIS DEVICE STATES THE FOLLOWING: PERFORATION OR OTHER ACUTE OR CHRONIC DAMAGE OF THE IVC WALL. THE ABOVE COMPLICATIONS HAVE BEEN ASSOCIATED WITH SERIOUS ADVERSE EVENTS SUCH AS MEDICAL INTERVENTION AND/OR DEATH. THERE HAVE BEEN REPORTS OF COMPLICATIONS, INCLUDING DEATH, ASSOCIATED WITH THE USE OF VENA CAVA FILTERS IN MORBIDLY OBESE PTS. THE RISK/BENEFIT RATIO OF ANY OF THESE COMPLICATIONS SHOULD BE WEIGHED AGAINST THE INHERENT RISK/BENEFIT FOR A PT WHO IS AT RISK OF PULMONARY EMBOLISM WITHOUT INTERVENTION.

    Description of Event or Problem · 1

    A PT THAT WAS STATUS POST BARIATRIC SURGERY, PRESENTED TO THE ER WITH LEG AND CHEST PAIN. US AND CT CONFIRMED THAT THE PT HAD FREE FLOATING CLOTS IN THE POPLITEAL VEINS AND A PE. THE DATE OF THE ER VISIT IS UNK. THE PT WAS ADMITTED TO THE ICU, PLACED ON HEPARIN, AND A G2 FILTER WAS IMPLANTED. AFTER 6 DAYS IN THE ICU, THE PT BEGAN HAVING INCREASED SYMPTOMS OF ABDOMINAL PAIN AND DIFFICULTY BREATHING. A CT ANGIOGRAM OF THE ABDOMEN AND PELVIS WAS PERFORMED. THE WRITTEN REPORT STATED THAT "ONE" STRUT APPEARED TO BE OUTSIDE THE CAVA WALL. IT WAS LATER REPORTED THAT THERE WERE "TWO" STRUTS AND THE "APEX" OUTSIDE OF THE CAVA WALL. IT APPEARED THAT THERE WAS "BLEEDING IN THE BELLY" SO A VASCULAR SURGEON WAS CONSULTED AND THE PT WAS IMMEDIATELY TRANSFERRED TO A LARGER HOSP. IT WAS REPORTED THAT THE FILTER WAS SURGICALLY REMOVED AND ANOTHER FILTER WAS IMPLANTED. THE PT DIED SOMETIME AFTER THE SURGERY. DEFINITIVE CAUSE OF DEATH IS UNK AND IT IS UNK IF AN AUTOPSY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 G2 FILTER SYSTEM FEMORAL DTK BARD PERIPHERAL VASCULAR, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Death