BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6000036-1999-00169

    MDR report key: 257040 · Received December 28, 1999

    Report

    Report Number
    6000036-1999-00169
    Event Type
    Malfunction
    Date Received
    December 28, 1999
    Report Date
    November 30, 1999
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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 LEFT FEMORAL APPROACH. ANOTHER FILTER WAS PLACED WHICH ALSO DID NOT APPEAR TO OPEN COMPLETELY, HOWEVER, THE PHYSICIAN FEELS THE PATIENT IS ADEQUATELY PROTECTED AND NO FURTHER ACTION WAS TAKEN. 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 SYSTEM DURING THE IMPLANT PROCEDURE WAS NOT PERFORMED. ALSO, THE ROUTE OF INSERTION WAS LEFT FEMORAL. CO BELIEVE THESE FACTORS MAY HAVE CONTRIBUTED TO THIS EVENT. HOWEVER, CO IS UNABLE TO DETERMINE THE EXACT CAUSE FOR THIS EVENT. OUR 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...DO NOT ATTEMPT A LEFT SIDE INSERTION UNLESS ALL OTHER ATTEMPTS ARE IMPOSSIBLE. SHEATH KINKING OR INSERTION DIFFICULTIES MAY RESULT DUE TO TORTUOUS LEFT-SIDED ANATOMY. THIS PRODUCT IS DESIGNED FOR RIGHT SIDED INSERTION VIA EITHER RIGHT INTERNAL JUGULAR OR RIGHT FEMORAL VEIN."

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN