BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENATECH LP VENA CAVA FILTER

    MDR report key: 4484758 · Received February 2, 2015

    Report

    Report Number
    3006332832-2015-00004
    Event Type
    Injury
    Date Received
    February 2, 2015
    Date of Event
    January 2, 2015
    Report Date
    February 2, 2015
    Manufacturer
    B. BRAUN MEDICAL SAS
    Product Code
    DTK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT PLACEMENT OF A VENATECH LP FILTER FOLLOWING A TRAUMATIC INJURY IN 2012. THE FILTER WAS PLACED AT AN OUTSIDE INSTITUTION. THE PATIENT WAS SEEN ON (B)(6) 2015 FOR ROUTINE PRE-OP CLEARANCE RELATED TO A SEPARATE ISSUE AND A CHEST X-RAY IDENTIFIED THAT THE FILTER HAD FRACTURED AND FRAGMENTS MIGRATED. THE PATIENT WAS EVALUATED BY INTERVENTIONAL RADIOLOGY AND CARDIAC SURGERY IS ANTICIPATED TO BE NECESSARY TO REMOVE THE MIGRATED FRAGMENTS. IMPORTER NARRATIVE AMENDMENT: B. BRAUN INTERVENTIONAL SYSTEMS INC. WOULD LIKE IT RECOGNIZED THAT THE INSTITUTION THAT ORIGINALLY PLACED THE FILTER IS UNKNOWN AND THAT IT IS UNKNOWN IF THE FILTER HAD MIGRATED, ONLY THAT THE FRAGMENTS WERE FOUND IN THE RIGHT ATRIUM. IT APPEARS FROM THE FILM REVIEW THAT THE FILTER WAS DISLODGED DURING A SUBSEQUENT VENOUS INTERVENTION, BUT THIS CANNOT BE CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73580 VENATECH LP VENA CAVA FILTER VENA CAVA FILTER DTK B. BRAUN MEDICAL SAS 31335

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R