BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    G2 FILTER SYSTEM

    MDR report key: 1903606 · Received November 16, 2010

    Report

    Report Number
    2020394-2010-00338
    Event Type
    Malfunction
    Date Received
    November 16, 2010
    Date of Event
    October 27, 2010
    Report Date
    October 27, 2010
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER FOR THE DEVICE IS NOT KNOWN. THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. THE FILTER REMAINS IMPLANTED IN THE PT. THEREFORE, A DEVICE EVALUATION COULD NOT BE PERFORMED. THE COMPLAINT INVESTIGATION IS INCONCLUSIVE. THE DEFINITIVE ROOT CAUSE IS UNK. ONE DIGITAL SUBTRACTION IMAGE WAS RECEIVED AND REVIEWED. NO LABELING WAS VISIBLE ON THE IMAGE. THE IVC FILTER IS CONFIRMED TO HAVE A BARD G2 CONFIGURATION. THE VENA CAVAGRAM SHOWS A G2 FILTER TILTED IN THE IVC APPROX 30 DEGREES AND ANGLED TO THE RIGHT. ONE FILTER ARM APPEARS TO BE ANGLED UPWARD IN A CEPHALAD DIRECTION APPROX 70 DEGREES FROM ITS ORIGINAL POSITION. NO LIMBS APPEAR TO BE UNUSUAL IN CONFIGURATION; HOWEVER, NOT ALL FILTER LIMBS ARE VISIBLE. THE IMAGE QUALITY IS VERY POOR AND AN ACCURATE ASSESSMENT OF THE FILTER LIMB CONFIGURATION CANNOT BE PERFORMED. THE IVC LUMEN IS NOT COMPLETELY OPACIFIED WITH CONTRAST DURING THE INJECTION; THEREFORE, AN EVALUATION FOR PERFORATION BY A FILTER LIMB CANNOT BE DETERMINED. CONTRAST EXTRAVASATION CANNOT BE SEEN. BASED ON THE IMAGE PROVIDED, A FILTER TILT CAN BE CONFIRMED. A PERFORATION OF THE IVC CANNOT BE CONFIRMED. THE DEFINITIVE ROOT CAUSE IS UNK. THE CURRENT IFU (INSTRUCTIONS FOR USE) STATES: POTENTIAL COMPLICATIONS: COMPLICATIONS MAY OCCUR AT ANY TIME DURING OR AFTER THE PROCEDURE. POSSIBLE COMPLICATIONS INCLUDE, BUT ARE NOT LIMITED TO: PERFORATION OR OTHER ACUTE OR CHRONIC DAMAGE OF THE IVC WALL. FILTER TILT. FILTER MALPOSITION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO A SCHEDULED RETRIEVAL, IMAGING DEMONSTRATED THAT THE FILTER WAS TILTED AND ONE OF THE FILTER LEGS APPEARED TO BE POINTING IN A CEPHALAD DIRECTION. REPORTEDLY, THE PHYSICIAN STATED THAT THE FILTER LEG APPEARED TO BE OUTSIDE OF THE CAVA WALL AND EXTRAVASATION WAS NOTED. IN ADDITION, THE PHYSICIAN STATED THE APEX OF THE FILTER APPEARED TO BE OUTSIDE THE CONTRAST COLUMN, HOWEVER, NO EXTRAVASATION WAS SEEN. ATTEMPTS TO RETRIEVE THE FILTER WERE NOT PERFORMED AND THE FILTER WILL REMAIN PERMANENTLY IMPLANTED. THE PT IS ASYMPTOMATIC.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR