BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TITANIUM GREENFIELD VENA CAVA FILTER

    MDR report key: 296855 · Received September 19, 2000

    Report

    Report Number
    6000036-2000-00078
    Event Type
    Malfunction
    Date Received
    September 19, 2000
    Date of Event
    August 17, 2000
    Report Date
    August 21, 2000
    Manufacturer
    MEDI-TECH / A DIV OF BOSTON SCIENTIFIC CORP.
    Product Code
    DTK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THIS FILTER DID NOT APPEAR TO OPEN COMPLETELY FOLLOWING DEPLOYMENT VIA A JUGULAR APPROACH. MANIPULATION OF THE FILTER WITH A DILATOR AND A "J" TIP STYLE GUIDEWIRE WAS UNSUCCESSFUL IN ACHIEVING A COMPLETE OPENING. ANOTHER FILTER WAS THEN DEPLOYED VIA A JUGULAR APPROACH, WHICH ALSO DID NOT APPEAR TO OPEN COMPLETELY. MANIPULATION ATTEMPTS WERE AGAIN UNSUCCESSFUL IN ACHIEVING A COMPLETE OPENING. THE PHYSICIAN FEELS THE PT IS PROTECTED AND A THIRD FILTER WAS NOT PLACED. THIS DEVICE REMAINS IMPLANTED. THEREFORE, NO FAILURE ANALYSIS WILL BE AVAILABLE. F/U INDICATED CONTINUAL FLUSHING OF THE CARRIER SYSTEM DURING THE IMPLANT PROCEDURE WAS NOT PERFORMED WHICH CO BELIEVES MAY HAVE CONTRIBUTED TO THIS EVENT. HOWEVER, CO IS UNABLE TO DETERMINE THE EXACT CAUSE FOR THIS EVENT. DIRECTIONS FOR USE: "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# 6000036-2000-00076.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TITANIUM GREENFIELD VENA CAVA FILTER VENA CAVA FILTER DTK MEDI-TECH / A DIV OF BOSTON SCIENTIFIC CORP. NA 3147575

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN