BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TITANIUM GREENFIELD VENA CAVA FILTER

    MDR report key: 161896 · Received April 7, 1998

    Report

    Report Number
    6000036-1998-00080
    Event Type
    Malfunction
    Date Received
    April 7, 1998
    Report Date
    April 6, 1998
    Manufacturer
    MEDI-TECH A DIV. OF BOSTON SCIENTIFIC CORP.
    Product Code
    DTK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO RECEIVED AFTER INITIAL MEDWATCH REPORT WAS FILED REVEALED THIS TERMINAL PT EXPIRED DUE TO AN UNRELATED PULMONARY CONDITION.

    Description of Event or Problem · 1

    IT WAS REPORTED A FILTER DID NOT APPEAR TO OPEN COMPLETELY FOLLOWING DEPLOYMENT VIA A JUGULAR APPROACH. THIS FILTER WAS THEN PLACED WHICH ALSO DID NOT APPEAR TO OPEN COMPLETELY. THE PHYSICIAN CHOSE NOT TO PLACE A THIRD FILTER. THE PHYSICIAN INDICATED THE SHAPE OF THE CAVA MAY HAVE CONTRIBUTED TO THIS EVENT. THIS DEVICE REMAINS IMPLANTED. THEREFORE, NO FAILURE ANALYSIS WILL BE AVAILABLE. IT WAS INDICATED A PRE-PLACEMENT CAVOGRAM WAS NOT PERFORMED PRIOR TO FILTER PLACEMENT AND CONTINUAL FLUSHING OF THE CARRIER SYS DURING THE IMPLANT PROCEDURE WAS NOT PERFORMED. CO BELIEVES THESE FACTORS, AS WELL AS THE SHAPE OF THE CAVA, MAY HAVE CONTRIBUTED TO THIS EVENT. CO'S DIRECTIONS FOR USE STATE: "AN INFERIOR VENA CAVOGRAM MUST BE PERFORMED PRIOR TO TITANIUM GREENFIELD VENA CAVA FILTER INSERTION. THIS PROCEDURE DETERMINES CAVAL PATENCY AND DIAMETER AND IS USED TO EVALUATE THE INFERIOR VENA CAVA FOR THE PRESENCE OF THROMBUS AND CONGENITAL ANOMALIES...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 #6000036-1998-00067.

    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 DIV. OF BOSTON SCIENTIFIC CORP. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN