BEUDAMED
    FDA Adverse Event Death Summary report: N

    VENATECH LP

    MDR report key: 7391373 · Received April 3, 2018

    Report

    Report Number
    9612452-2018-00016
    Event Type
    Death
    Date Received
    April 3, 2018
    Date of Event
    February 25, 2016
    Report Date
    March 30, 2018
    Manufacturer
    B.BRAUN MEDICAL SAS
    Product Code
    DTK
    PMA / PMN Number
    K010485
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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 (B)(6) 2015, PATIENT WAS IMPLANTED WITH THE LP FILTER AT NORTHWESTERN MEMORIAL HOSPITAL. ON (B)(6) 2016, PERCUTANEOUS REMOVAL OF THE LP FILTER WHICH HAD ALLEGEDLY MIGRATED TO THE HEART WAS PERFORMED AT RUSH UNIVERSITY MEDICAL CENTER. REMOVAL OF RESIDUAL THROMBUS IN THE RIGHT ATRIUM WAS ATTEMPTED DURING THE PROCEDURE, HOWEVER, A PORTION OF THE THROMBUS WAS UNABLE TO BE REMOVED. ON (B)(6) 2016, PATIENT PASSED AWAY AS A RESULT OF METASTATIC LUNG CANCER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235023 VENATECH LP VENA CAVA FILTER DTK B.BRAUN MEDICAL SAS 31335

    Patients

    Seq Age Sex Outcome Treatment
    1 Death