BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENATECH LP VENA CAVA FILTER

    MDR report key: 3030684 · Received March 22, 2013

    Report

    Report Number
    9612452-2013-00001
    Event Type
    Injury
    Date Received
    March 22, 2013
    Date of Event
    January 30, 2013
    Report Date
    March 21, 2013
    Manufacturer
    B. BRAUN MEDICAL SAS
    Product Code
    DTK
    PMA / PMN Number
    K010485
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW: WE HAVE CHECKED THE MFG FILE OF THIS LOT OF VENA CAVA FILTERS, WHICH COMPLIES WITH OUR SPECS AND DOES NOT PRESENT ANY ABNORMALITY. NO OTHER SIMILAR INCIDENTS WERE DECLARED TO US CONCERNING THIS LOT OF 58 VENA CAVA FILTERS, SOLD SINCE AUGUST 2012. INVESTIGATION RESULTS: THE INVOLVED DEVICE IS NOT AVAILABLE FOR INVESTIGATION NOR THE X-RAY PICTURES, CONSEQUENTLY NO THOROUGH INVESTIGATION CAN BE PERFORMED. CONCLUSION: AS NEITHER THE DEVICE NOT X-RAY PICTURES COPY WERE RETURNED TO US FOR EVAL, WE CANNOT CONCLUDE TO THE REAL CAUSE OF THIS INCIDENT. THIS CASE IS REGISTERED FOR STATISTICAL PURPOSE. THIS DATABASE, WHICH WE ACTIVELY MONITOR AND TREND TO ENSURE WE REACT QUICKLY AND EFFECTIVELY TO THE EXPERIENCES REPORTED FROM THE USE OF OUR PRODUCTS. (B)(4). NO CORRECTIVE ACTION IS ENVISAGED.

    Description of Event or Problem · 1

    A VENATECH LP VENA CAVA FILTER WAS PLACED IN THE PT ON (B)(6) 2013 IN THE INTERVENTIONAL RADIOLOGY DEPARTMENT DUE TO DVT. ON (B)(6) 2013, THE PT HAD A CHEST CT TO RULE OUT PE. THE 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, A CHEST CT SHOWED THE 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 NODAL RHYTHM THAT REQUIRED TEMPORARY PACING, AND LATER, A PACEMAKER WAS PLACED ON (B)(6) 2013. THE PT WAS DISCHARGED FROM THE INPATIENT HOSPITAL SETTING TO INPATIENT REHAB ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119565 VENATECH LP VENA CAVA FILTER VENA CAVA FILTER DTK B. BRAUN MEDICAL SAS 31335 L198756V

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R