BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREENFIELD 12FR SS VENA CAVA FILTER

    MDR report key: 1033358 · Received April 24, 2008

    Report

    Report Number
    2134265-2008-01176
    Event Type
    Injury
    Date Received
    April 24, 2008
    Date of Event
    March 21, 2008
    Report Date
    March 25, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DTK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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

    IT WAS REPORTED THAT DURING AN INFERIOR VENA CAVA FILTER PLACEMENT PROCEDURE, DEPLOYMENT DIFFICULTIES WERE ENCOUNTERED. FOLLOWING A VENACAVOGRAM, THE INFERIOR VENA CAVA WAS DETERMINED TO BE PATENT AND 26MM. THE GREENFIELD VENA CAVA FILTER WAS THEN ADVANCED WITH THE SUPERIOR TIP TARGETED AT THE LEVEL OF THE CONFLUENCE OF THE RENAL VEINS, AT THE LEVEL OF THE LOWER BODY L1. UPON DEPLOYMENT, THERE WAS INCOMPLETE EXPANSION OF 2 OF THE FILTER LEGS, AND SOME MOTION OF THE FILTER WITH RESPIRATIONS. THROUGH THE DEPLOYMENT SHEATH, MANIPULATIONS WITH A GLIDEWIRE WERE ATTEMPTED, HOWEVER, THIS WAS UNSUCCESSFUL. THE FILTER PLACEMENT SHEATH WAS EXCHANGED WITH A VASCULAR SHEATH, AND A 10MM SNARE CATHETER WAS THEN INSERTED AND PLACED OVER THE NOSE OF THE FILTER TO SECURE IT. THE SNARE WAS TIGHTENED/LOOSENED IN AN EFFORT TO DEPLOY THE FILTER, HOWEVER THIS WAS UNSUCCESSFUL. THE SNARE WAS THEN WITHDRAWN TO THE LEVEL OF MID-FILTER AND TIGHTENED/LOOSENED WHICH THEN SUCCESSFULLY DEPLOYED THE GREENFIELD VENA CAVA FILTER COMPLETELY. THE SNARE WAS THEN REMOVED, AND FULL DEPLOYMENT OF THE FILTER WAS CONFIRMED BY VENOCAVOGRAM. NO PT COMPLICATIONS WERE REPORTED, AND THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. 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 Required Intervention