BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK CELECT NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTERS

    MDR report key: 1891315 · Received November 2, 2010

    Report

    Report Number
    3002808486-2010-00014
    Event Type
    Injury
    Date Received
    November 2, 2010
    Date of Event
    September 7, 2010
    Report Date
    September 9, 2010
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    PMA / PMN Number
    K061815
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE SALES REP HAS BEEN UNABLE TO REACH THE PHYSICIAN IN PERSON. ALL INFORMATION GIVEN HAS BEEN SECOND OR THIRD HAND, OR "MENTIONED IN PASSING". APPARENTLY PT HAD A CELECT FILTER IN PLACE, DWELL TIME UNK. TWO DIFFERENT VERSIONS OF THE INCIDENT HAVE BEEN HEARD. IN ONE THE PT COMPLAINED OF PAIN. ON VISUALIZING ABDOMEN, IT WAS THOUGHT A LEG WAS PROTRUDING THROUGH VENA CAVA AND EXTRAVAZATION COULD BE SEEN FROM THE LOCALE. SIDE VIEW ALLEGEDLY SHOWED LEG PIERCING A SECONDARY VEIN WHICH WAS THE ONE ACTUALLY BLEEDING. FILTER WAS REMOVED SURGICALLY. IN THE SECOND VERSION, THE FILTER LEG WAS SHOWN TO BE PROTRUDING THROUGH THE VENA CAVA INTO A BONE. FILTER WAS REMOVED SURGICALLY AND AS IT WAS REMOVED THE PROTRUDING LEG FRACTURED AND REMAINS IN PT. RETRIEVED FILTER WAS GIVEN TO THE PT TO TAKE HOME. WE HAVE NO WAY TO DETERMINE IF THESE ARE ACTUALLY TWO DIFFERENT COMPLAINT DEVICES IN TWO DIFFERENT PTS OR VARIATIONS ON THE SAME INDIVIDUAL OR IF THEY ARE DEFINITELY CELECT FILTERS. CELECT IS THE FILTER OF CHOICE IN THIS ACCOUNT AND ONE RT TOLD IT "DEFINITELY WAS A CELECT". UPON HEARING THE COMPLAINT THE REP IMMEDIATELY E-MAILED ANOTHER PHYSICIAN (THE NAME SHE HAD BEEN GIVEN) WHO RESPONDED WE SHOULD CONTACT HIS PARTNER THE PHYSICIAN WHO OPERATED ON THE PT. THAT PHYSICIAN WAS E-MAILED BUT DID NOT RECEIVE A RESPONSE FROM HIM. THEIR ACADEMIC COORDINATOR WAS CALLED, LEAVING A MESSAGE BUT HAS NOT HEARD BACK FROM HER WITH A RESPONSE EITHER. MAYBE IN ONE RETELLING OF THE COMPLAINT A PIECE OF FILTER LEG REMAINS IN PT. THE EVALUATION IS BASED ON THE DESCRIPTION ONLY SINCE NO DEVICE OR IMAGES WERE RETURNED TO ASSIST THE INVESTIGATION. IN THE AVAILABLE INFORMATION TWO VERSIONS OF THE INCIDENT ARE GIVEN. THE AVAILABLE INFORMATION DOES NOT GIVE THE OPPORTUNITY TO EVALUATE THE EVENT THOROUGHLY. ALSO IT IS NOT CLEAR WHAT CAUSED THE FILTER TO BE REMOVED SURGICALLY AND NOT BY ENDOVASCULAR PROCEDURE. THEREFORE, BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO CONCLUDE THE EXACT ROOT CAUSE TO THIS EVENT. HOWEVER, FILTER PERFORATION OF THE VENA CAVA WALL IS A WELL KNOWN RISK. SEVERAL CASE REPORTS PUBLISHED IN ARTICLES, DESCRIBE FILTER PERFORATION OF THE VENA CAVA WALL. DESPITE PERFORATION THEY ALL END UP IN SUCCESSFUL FILTER RETRIEVAL. ACCORDING TO ARTICLE [1] "THERE ARE NO PUBLISHED GUIDELINES FOR SURGICAL OR ENDOVASCULAR REMOVAL OF PERFORATED IVC FILTERS. REMOVAL IS CONSIDERED BASED ON THE SEVERITY OF SYMPTOMS AND PERCEIVED LONG TERM ADVERSE OUTCOMES". NO DEVICE WAS REC'D TO ASSIST IN THIS INVESTIGATION. THE APPROPRIATE INTERNAL PERSONNEL WERE NOTIFIED. WE WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOK CELECT NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTERS DTK, FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention