BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERIDIAN FILTER SYSTEM - FEMORAL

    MDR report key: 3143041 · Received May 23, 2013

    Report

    Report Number
    2020394-2013-00167
    Event Type
    Injury
    Date Received
    May 23, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 10, 2013
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DTK
    PMA / PMN Number
    K112497
    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 HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE RAW MATERIALS, THE SUBASSEMBLIES, THE MANUFACTURING PROCESS AND THE QUALITY CONTROL TESTING. THIS LOT MET ALL RELEASE CRITERIA. THERE WAS NOTHING FOUND TO INDICATE THERE WAS A MANUFACTURING RELATED CAUSE FOR THIS EVENT. THIS IS THE ONLY COMPLAINT REPORTED TO DATE FOR CORPORATE LOT NUMBER GFW2269 FOR THIS FAILURE MODE. THE DEVICE WAS NOT RETURNED. IMAGES WERE NOT PROVIDED. THE COMPLAINT INVESTIGATION IS INCONCLUSIVE FOR THE REPORTED FILTER LIMB DETACHMENT. BASED UPON THE AVAILABLE INFO, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNK. THE CURRENT IFU (INSTRUCTIONS FOR USE) STATES: WARNINGS/POTENTIAL COMPLICATIONS: FILTER FRACTURES ARE A KNOWN COMPLICATION OF VENA CAVA FILTERS. THERE HAVE BEEN SOME REPORTS OF SERIOUS PULMONARY AND CARDIAC COMPLICATIONS WITH VENA CAVA FILTERS REQUIRING THE RETRIEVAL OF THE FRAGMENT UTILIZING ENDOVASCULAR AND/OR SURGICAL TECHNIQUES. PAIN. NOTE: IT IS POSSIBLE THAT COMPLICATIONS SUCH AS THOSE DESCRIBED IN THE "WARNINGS", "PRECAUTIONS," OR "POTENTIAL COMPLICATIONS" OF THIS INSTRUCTIONS FOR USE MAY AFFECT THE RECOVERABILITY OF THE DEVICE AND RESULT IN THE CLINICIAN'S DECISION TO HAVE THE DEVICE REMAIN PERMANENTLY IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROX TWO MONTHS POST VENA CAVA FILTER IMPLANT, THE PT PRESENTED TO THE HOSPITAL WITH CHEST PAIN AND A DETACHED FILTER LIMB WAS DISCOVERED IN THE RIGHT ATRIUM. A PERICARDIOCENTESIS WAS PERFORMED AND AN ATTEMPT WAS MADE TO RETRIEVE THE DETACHED LIMB FROM THE HEART; HOWEVER, IT APPEARED THAT THE LIMB WAS EMBEDDED IN THE RIGHT ATRIAL WALL AND THE ATTEMPT WAS UNSUCCESSFUL. THE PT WAS TRANSFERRED TO ANOTHER HOSPITAL IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230230 MERIDIAN FILTER SYSTEM - FEMORAL DTK BARD PERIPHERAL VASCULAR, INC. GFWK2269

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R PERICARDIOCENTESIS