BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENATECH LP

    MDR report key: 6867960 · Received September 15, 2017

    Report

    Report Number
    9612452-2017-00043
    Event Type
    Injury
    Date Received
    September 15, 2017
    Date of Event
    August 7, 2017
    Report Date
    September 14, 2017
    Manufacturer
    B.BRAUN MEDICAL SAS
    Product Code
    DTK
    UDI-DI
    04038653918164
    PMA / PMN Number
    K010485
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH HISTORY REVIEW: THE MANUFACTURING FILE OF THIS BATCH OF VENA CAVA FILTERS HAS BEEN REVIEWED. IT COMPLIES WITH OUR SPECIFICATIONS AND DOES NOT PRESENT ANY DISCREPANCY. NO OTHER INCIDENT HAS BEEN REPORTED ON THE BATCH SOLD SINCE APRIL 2017. THE EXAMINATION OF THE X-RAY DATED ON (B)(6) 2017 SHOWS: -PARTIALLY EXPANDED VENATECH LP FILTER IMPLANTED IN THE INFRA-RENAL IVC. NO FILTER ARM OR STABILIZER TANGLING NOTED. BALLOON DILATATION OF FILTER ATTEMPTED, RESULTING IN FILTER MOVEMENT TO RIGHT RENAL VEIN. FILTER REPOSITIONED TO INFRA-RENAL IVC VIA ENDOVASCULAR FORCEPS, RESULTING IN COMPLETELY EXPANDED LP FILTER. CONCLUSION: THE ELEMENTS IN OUR POSSESSION DO NOT ALLOW US TO FIND THE EXACT ROOT CAUSE OF THE FILTER NON-EXPANSION. HOWEVER NO FILTER ARM TANGLING IS NOTED AND AFTER MANIPULATION THE ARMS COULD BE OPENED. THIS SEEMS TO INDICATE THAT THE EXPANSION FAILURE IS NOT DUE TO A MANUFACTURING DEFECT. AS IT IS A RARE ISSUE, NO CORRECTIVE ACTION IS ENVISAGED. B BRAUN MEDICAL SAS HAS PROVIDED ALL THE INFORMATION CURRENTLY AVAILABLE. IN SPITE OF ALL REASONABLE EFFORTS BEING MADE TO OBTAIN FURTHER INFORMATION, AT THIS TIME WE HAVE NOT MET WITH SUCCESS.

    Description of Event or Problem · 1

    FILTER LEGS DID NOT OPEN. DEVICE DID NOT MOVE UPON IMPLANTATION, BUT WAS PARTIALLY PUSHED INTO THE RENAL VEIN UPON BALLOON MANIPULATION. PHYSICIAN HAD TO GRASP THE FILTER LEGS TO PULL THE FILTER BACK INTO THE IVC. THE LP FILTER WAS PLACED AFTER A TEMPORARY FILTER WAS REMOVED UPON DETERMINATION THAT THE PATIENT WOULD NEED PERMANENT FILTRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649386 VENATECH LP VENA CAVE FILTER SYSTEM DTK B.BRAUN MEDICAL SAS 31335 36918454 04038653918164

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention