BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENATECH LP

    MDR report key: 2973853 · Received February 15, 2013

    Report

    Report Number
    MW5029028
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    January 30, 2012
    Report Date
    February 13, 2013
    Manufacturer
    B. BRAUN
    Product Code
    DTK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013, VENATECH LP FILTER WAS PLACED DUE TO DVT. ON (B)(6) 2013, PT HAD A CHEST CT TO RULE OUT PULMONARY EMBOLUS. CHEST CT SHOWED MULTIPLE BILATERAL PULMONARY EMBOLI WITH THE VENOUS FILTER SEEN WITHIN THE INTRAHEPATIC SEGMENT OF THE INFERIOR VENA CAVA. ON (B)(6) 2013, CHEST CT SHOWED THAT THE VENOUS FILTER WAS LARGELY IN THE RIGHT VENTRICLE WITH PARTIAL ATTACHMENT TO THE TRICUSPID VALVE. ON (B)(6) 2013, THE PT HAD SURGERY TO REMOVE THE DISLODGED CAVAL FILTER WITHIN THE RIGHT VENTRICLE. THE PT HAD A MODEL RHYTHM THAT REQUIRED TEMPORARY PACING, AND LATER A PERMANENT PACEMAKER WAS REQUIRED, PLACED ON (B)(6) 2013. THE PT WAS DISCHARGED FROM THE IMPATIENT HOSPITAL SETTING TO IMPATIENT REHAB ON (B)(6) 2013. THE CARDIOTHORACIC SURGEON NOTES THAT THE MFR WAS CONTACTED AND IT WAS FELT POSSIBLE THAT A LARGE CLOT MAY HAVE DISLODGE THE FILTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69536 VENATECH LP VENA CAVA FILTER DTK B. BRAUN L198756V

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention