BEUDAMED
    FDA Adverse Event Injury Summary report: N

    G2 FILTER SYSTEM, JUGULAR

    MDR report key: 1141069 · Received August 29, 2008

    Report

    Report Number
    2020394-2008-00243
    Event Type
    Injury
    Date Received
    August 29, 2008
    Date of Event
    August 4, 2008
    Report Date
    August 8, 2008
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K052578
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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 AS IT WILL NOT BE RELEASED BY THE HOSPITAL. BASED ON THE INFORMATION RECEIVED, THE RESULTS ARE INCONCLUSIVE AND THE ROOT CAUSE OF THE EVENT IS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT TO DATE, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. 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: MIGRATION. MOVEMENT OR MIGRATION OF THE FILTER IS A KNOWN COMPLICATION OF VENA CAVA FILTERS. THIS MAY BE CAUSED BY PLACEMENT IN IVC'S WITH DIAMETERS EXCEEDING THE APPROPRIATE LABEL DIMENSIONS SPECIFIED IN THE IFU. PERFORATION OR OTHER ACUTE OR CHRONIC DAMAGE OF THE IVC WALL. THIS WAS A BARIATRIC PATIENT. THE CURRENT IFU (INSTRUCTIONS FOR USE) STATES THE FOLLOWING: THERE HAVE BEEN REPORTS OF COMPLICATIONS INCLUDING DEATH, ASSOCIATED WITH THE USE OF VENA CAVA FILTERS IN MORBIDLY OBESE PATIENTS. THE RISK/BENEFIT RATIO OF ANY OF THESE COMPLICATIONS SHOULD BE WEIGHED AGAINST THE INHERENT RISK/BENEFIT RATIO FOR A PATIENT WHO IS AT RISK OF PULMONARY EMBOLISM WITHOUT INTERVENTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN REPORTED AN INCIDENT OF ALLEGED CAUDAL MIGRATION AND PERFORATION FROM A JUGULAR IVC FILTER. THIS WAS A BARIATRIC PATIENT, PRE SURGERY. THE FILTER WAS IMPLANTED AND WITHIN A FEW DAYS, THE PATIENT PRESENTED TO THE ER WITH PAIN (SITE UNKNOWN). A CT WAS DONE AND ALLEGEDLY THE PHYSICIAN CONFIRMED THE MIGRATION AND PERFORATION. RETRIEVAL OF THE FILTER WAS CONFIRMED, BUT DATES AND DETAILS ARE UNKNOWN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention