BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TITANIUM GREENFIELD VENA CAVA FILTER

    MDR report key: 246591 · Received October 25, 1999

    Report

    Report Number
    6000036-1999-00142
    Event Type
    Malfunction
    Date Received
    October 25, 1999
    Date of Event
    September 29, 1999
    Report Date
    September 30, 1999
    Manufacturer
    MEDI-TECH A DIVISION OF BOSTON SCIENTIFIC CORP.
    Product Code
    DTK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED A FILTER DID NOT APPEAR TO OPEN COMPLETELY FOLLOWING DEPLOYMENT VIA A JUGULAR APPROACH. ANOTHER FILTER WAS THEN DEPLOYED VIA A JUGULAR APPROACH, AND ALSO DID NOT APPEAR TO OPEN COMPLETELY. A THIRD FILTER WAS SUCCESSFULLY PLACED VIA A JUGULAR APPROACH WITHOUT ANY PT COMPLICATIONS. THIS DEVICE REMAINS IMPLANTED. THEREFORE, NO FAILURE ANALYSIS WILL BE AVAILABLE. IT WAS INDICATED CONTINUAL FLUSHING OF THE CARRIER SYSTEM DURING THE IMPLANT PROCEDURE WAS NOT PERFORMED, WHICH THE CO BELIEVES MAY HAVE CONTRIBUTED TO THIS EVENT. HOWEVER, THE CO IS UNABLE TO DETERMINE THE EXACT CAUSE FOR THIS EVENT. DIRECTIONS FOR USE STATE: "DO NOT ATTEMPT TO MOVE OR MANIPULATE AN ENGAGED FILTER...IN MOST CASES, A SECOND FILTER, PROPERLY PLACED, SHOULD BE IMPLANTED FOR PROTECTION AGAINST RECURRENT PE... THE INTRODUCER CATHETER MUST BE FLUSHED THROUGH THE FLUSH PORT BY FREQUENT INJECTION OR CONTINUOUS INFUSION OF STERILE HEPARINIZED SALINE DURING THE IMPLANT PROCEDURE... INSUFFICIENT FLUSHING CAN ALLOW THROMBUS FORMATION INSIDE THE TITANIUM GREENFIELD VENA CAVA FILTER WHICH CAN BIND THE LEGS AND PREVENT COMPLETE OPENING UPON RELEASE." SAME CASE AS MFR REPORT # 6000036-1999-00143.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TITANIUM GREENFIELD VENA CAVA FILTER Implant VENA CAVA FILTER DTK MEDI-TECH A DIVISION OF BOSTON SCIENTIFIC CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN