BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G2 FILTER SYSTEM, FEMORAL

    MDR report key: 1131929 · Received August 22, 2008

    Report

    Report Number
    2020394-2008-00238
    Event Type
    Injury
    Date Received
    August 22, 2008
    Date of Event
    August 1, 2008
    Report Date
    August 1, 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
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED, AS THE LOT NUMBER WAS UNKNOWN. THE SAMPLE HAS NOT BEEN RETURNED FOR EVALUATION. BASED ON THE REVIEW OF THE RETURNED ELECTRONIC IMAGES, THE RESULTS OF THE INVESTIGATION ARE CONFIRMED FOR TILTING, MALPOSITION AND PERFORATION. THE ROOT CAUSE OF THIS EVENT IS UNKNOWN. THE CURRENT IFU (INSTRUCTIONS FOR USE) FOR THIS DEVICE STATES: COMPLICATIONS MAY OCCUR AT ANY TIME DURING OR AFTER THE PROCEDURE. POTENTIAL COMPLICATIONS INCLUDE, BUT ARE NOT LIMITED TO: PERFORATION OR OTHER ACUTE OR CHRONIC DAMAGE OF THE IVC WALL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FEMORAL VENA CAVA FILTER THAT WAS IMPLANTED A MONTH EARLIER, WAS TILTED WITH SEVERAL OF THE FILTER LIMBS PERFORATING THE CAVA WALL. THE PATIENT HAD A HISTORY OF DVT AND PE AND WAS ON COUMADIN. THE PATIENT DEVELOPED CHOLECYSTITIS, SO PRIOR TO GALL BLADDER SURGERY, THE PATIENT WAS TAKEN OFF OF COUMADIN AND HAD AN IVC FILTER IMPLANTED PRIOR TO SURGERY. IT WAS THE PHYSICIAN'S BELIEF THAT "IF THEY WAITED FOR THE IVC FILTER TO SEAT PROPERLY, BEFORE UNDERGOING SURGERY, IT MAY NOT HAVE MOVED." WHEN THE PATIENT PRESENTED A MONTH LATER FOR REMOVAL OF THE FILTER, A CT SCAN REVEALED THAT AT LEAST THREE LEGS HAD PERFORMED THE CAVA WALL AND ONE WAS CLOSE TO THE AORTA AND ANOTHER ONE CLOSE TO THE DUODENUM. AN ATTEMPT WAS MADE TO RETRIEVE THE FILTER, BUT UNSUCCESSFULLY, AS IT WAS REPORTED THAT THE APEX WAS TILTED AND EMBEDDED INTO THE CAVA WALL. THE PATIENT WAS SENT HOME, BUT RETURNED THE NEXT DAY WITH ABDOMINAL PAIN. THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL WHERE A VASCULAR SURGEON REMOVED THE FILTER. IT WAS REPORTED THAT AN IVC VENOTOMY WAS PERFORMED. IT WAS REMOVED SURGICALLY BECAUSE IT WAS NOT ONLY TILTED BUT THERE WAS A FIBROUS CAP THAT PROBABLY MADE IT DIFFICULT TO CAPTURE. THE LIMBS WERE IDENTIFIED OUTSIDE THE IVC AND THE PHYSICIAN CUT THE HOOKS WHILE THEY WERE OUT BECAUSE HE DID NOT WANT TO TEAR THE WALL WHILE PULLING THE FILTER OUT. THE PATIENT IS CURRENTLY ASYMPTOMATIC.

    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 31 YR Required Intervention