BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREENFIELD 12FR SS VENA CAVA FILTER

    MDR report key: 1033244 · Received April 15, 2008

    Report

    Report Number
    2134265-2008-01101
    Event Type
    Injury
    Date Received
    April 15, 2008
    Date of Event
    March 5, 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 FACILITY MEDWATCH RECEIVED AND ATTACHED. IT WAS REPORTED THAT DURING A FILTER PLACEMENT PROCEDURE, THE FILTER DID NOT DEPLOY. THE INSERTION SITE WAS THE LEFT FEMORAL VEIN. FOLLOWING INSERTION OF AN UNK MFR'S GUIDE WIRE, THE TRACT INTO THE FEMORAL VEIN WAS SEQUENTIALLY DILATED OVER THE GUIDE WIRE. THE GREENFIELD VENA CAVA FILTER WAS THEN PASSED INTO THE INFERIOR VENA CAVA AND FLUOROSCOPICALLY GUIDED TO DEPLOY OVER THE SECOND AND THIRD LUMBAR VERTEBRAE WITH THE FEET OF THE FILTER AT THE LOWER EDGE OF THE VERTEBRAL BODY AND THE TIP IN THE MIDPORTION OF THE SECOND LUMBAR VERTEBRAL BODY. HOWEVER, THE LEGS OF THE GREENFIELD VENA CAVA FILTER APPEARED TO BE CROSSED AND NOT OPENED COMPLETELY. THEREFORE, A SECOND FILTER WAS PLACED SUCCESSFULLY JUST BELOW THE ORIGINAL ONE. THE PHYSICIAN FEELS THAT THE PT IS ADEQUATELY PROTECTED FOLLOWING PLACEMENT OF THE SECOND FILTER. PT STATUS WAS REPORTED AS "OKAY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GREENFIELD 12FR SS VENA CAVA FILTER DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK BOSTON SCIENTIFIC NA 11344412

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| O