BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREENFIELD 12 FR SS VENA CAVA FILTER

    MDR report key: 1033243 · Received April 15, 2008

    Report

    Report Number
    2134265-2008-01106
    Event Type
    Injury
    Date Received
    April 15, 2008
    Date of Event
    March 18, 2008
    Report Date
    March 19, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DTK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DELIVERY DEVICE WILL NOT BE RETURNED FOR EVAL, AND THE FILTER REMAINS IMPLANTED; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PROD FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    VOLUNTARY MEDWATCH RECEIVED AND ATTACHED. IT WAS REPORTED THAT DURING A FILTER PLACEMENT PROCEDURE, THE FILTER DID NOT DEPLOY COMPLETELY. THE INSERTION SITE WAS THE LEFT FEMORAL VEIN. FOLLOWING INSERTION OF THE UNK MFR'S GUIDE WIRE, THE TRACT INTO THE LEFT FEMORAL VEIN WAS SEQUENTIALLY DILATED OVER THE GUIDE WIRE. THE GREENFIELD VENA CAVA FILTER WAS THEN PASSED INTO THE INFERIOR VENA CAVA SUCH THAT THE TIP WAS AT THE MIDPORTION OF THE SECOND VERTEBRAL BODY, AND THE LEGS WERE AT THE BOTTOM OF THE THIRD VERTEBRAL BODY. THE GREENFIELD VENA CAVA FILTER WAS DEPLOYED; HOWEVER, IT DID NOT SPRING OPEN. PER FLUOROSCOPY, IT WAS SHOWN THAT "THE UMBRELLA DID NOT DEPLOY COMPLETELY TO FILL THE CIRCUMFERENCE OF THE VENA CAVA." A SECOND GREENFIELD VENA CAVA FILTER WAS PLACED A LITTLE BIT LOWER THAN THE BOTTOM OF THE THIRD LUMBAR VERTEBRAE. THE SECOND FILTER DEPLOYED PROPERLY AND WAS WELL SITUATED. THE PHYSICIAN FELT THAT THE PT WAS ADEQUATELY PROTECTED WITH PLACEMENT OF THE SECOND FILTER. PT STATUS WAS REPORTED AS "OKAY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREENFIELD 12 FR SS VENA CAVA FILTER DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK BOSTON SCIENTIFIC NA 11440611

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Hospitalization| O