BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GREENFIELD¿

    MDR report key: 3002541 · Received March 13, 2013

    Report

    Report Number
    2134265-2013-01439
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    February 13, 2013
    Report Date
    February 13, 2013
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    DTK
    PMA / PMN Number
    K964284
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: THE COMPLAINT DEVICE WAS NOT RETURNED FOR ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID #: 2134265-2013-01436. IT WAS REPORTED THAT DURING A VENA CAVA FILTER PLACEMENT PROCEDURE, DEPLOYMENT ISSUES OCCURRED. THE PATIENT PRESENTED WITH CLOT RESTRICTED TO THE RIGHT COMMON FEMORAL VEIN. A 12F GREENFIELD STAINLESS STEEL FILTER WAS ADVANCED INTO THE VENA CAVA AND AN ATTEMPT TO DEPLOY WAS MADE. UPON DEPLOYMENT, THE LEGS OF THE FILTER DID NOT OPEN. A SECOND 12F GREENFIELD STAINLESS STEEL FILTER WAS IMMEDIATELY PLACED RIGHT ABOVE THE FIRST ONE; HOWEVER, UPON DEPLOYMENT THE LEGS DID NOT OPEN AND THE FILTER REMAINED ATTACHED TO THE CATHETER. THE FILTER EVENTUALLY RELEASED, BUT IN THE INFERIOR VENA CAVA (IVC). THE FIRST FILTER EVENTUALLY MIGRATED TO THE RIGHT ILIAC VEIN AND DEPLOYED IN THIS LOCATION. THIS FILTER WAS SECURE; HOWEVER, THE SECOND FILTER IN THE IVC WAS NOT. A VASCULAR SURGEON REMOVED THE SECOND FILTER. THE CASE WAS ABORTED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105696 GREENFIELD¿ FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK BOSTON SCIENTIFIC - CORK M001504000 15610205

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention