BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENATECH LP FILTER

    MDR report key: 6762764 · Received August 3, 2017

    Report

    Report Number
    9612452-2017-00033
    Event Type
    Injury
    Date Received
    August 3, 2017
    Date of Event
    June 26, 2015
    Report Date
    July 11, 2017
    Manufacturer
    B .BRAUN MEDICAL SAS
    Product Code
    DTK
    PMA / PMN Number
    K010485
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DESPITE REQUESTS, EITHER PRECISE INFORMATION ABOUT THE DEVICE NOR ABOUT THE INCIDENT NOR X-RAY PICTURES ARE AVAILABLE FOR ANALYSIS. BATCH HISTORY REVIEW: THE BATCH OF THE INVOLVED DEVICE IS UNKNOWN. INVESTIGATION: DESPITE REQUESTS, EITHER PRECISE INFORMATION ABOUT THE INCIDENT NOR X-RAY PICTURES ARE AVAILABLE FOR ANALYSIS. CONSEQUENTLY NO THOROUGH INVESTIGATION CAN BE PERFORMED. NO CONCLUSION CAN BE DRAWN. 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

    ON OR ABOUT (B)(6) 2003, PATIENT WAS IMPLANTED WITH A BRAUN VENATECH FILTER. ON (B)(6) 2015, PATIENT UNDERWENT A CT SCAN OF THE ABDOMEN AND PELVIS. EXAMINATION OF THE CT SCAN REVEALED THAT BOTH THE LEFT AND THE RIGHT POSTEROLATERAL STRUTS HAVE PENETRATED THROUGH THE CAVAL WALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544727 VENATECH LP FILTER VENA CAVA FILTER DTK B .BRAUN MEDICAL SAS

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability