BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK CELECT JUGULAR VENA CAVA FILTER SET

    MDR report key: 3962664 · Received July 16, 2014

    Report

    Report Number
    3002808486-2014-00024
    Event Type
    Injury
    Date Received
    July 16, 2014
    Date of Event
    June 19, 2012
    Report Date
    June 29, 2017
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    PMA / PMN Number
    K073374
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CATALOG #: UNK AS INFO WAS NOT PROVIDED EXCEPT REFERRED TO AS COOK CELECT FILTER. EXPIRATION DATE: UNK AS LOT # IS UNK. SUMMARY OF INVESTIGATION FINDINGS: RPN AND LOT NUMBER WERE NOT PROVIDED THEREFORE THE DEVICE HISTORY RECORD CANNOT BE INVESTIGATED. HOWEVER, NOTING INDICATES THE DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATION. AS NO DEVICE, IMAGING STUDIES OR HOSPITAL OR MEDICAL RECORDS HAVE BEEN PROVIDED OUR INVESTIGATION HAS BEEN LIMITED TO THE ALLEGATIONS IN THE LITIGATION. CONSEQUENTLY, BASED ON VERY LIMITED INFO IT IS DIFFICULT TO CONFIRM AND/OR COMMENT ON THE ALLEGED FILTER PERFORATION AND FILTER FRACTURE. THE COOK CELECT FILTER WAS ALLEGEDLY PLACED IN SVC, WHICH IS OFF LABEL USE, SINCE THE FILTER IS INTENDED FOR PLACEMENT IN THE IVC. INSTRUCTIONS FOR USE LIST DAMAGE TO THE VENA CAVA, AND VENA CAVA PERFORATION AS POTENTIAL ADVERSE EVENTS. SUCH EVENTS HAVE ALSO BEEN REPORTED IN THE PUBLISHED MEDICAL AND SCIENTIFIC LITERATURE. THE EXACT ROOT CAUSE FOR THE ALLEGED FILTER FRACTURE AND FILTER PERFORATION CANNOT BE DETERMINED BASED ON THE LIMITED INFO PROVIDED. MONITORING OF SIMILAR REPORTS WILL CONTINUE.

    Description of Event or Problem · 1

    ALLEGATIONS ACCORDING TO COMPLAINT: PT HAD A COOK IVC FILTER IMPLANTED ON OR ABOUT (B)(6) 2009 AND A COOK CELECT (SVC) FILTER PLACED IN THE SUPERIOR VENA CVA ON (B)(6) 2009. THERE WERE NO COMPLICATIONS AT THE TIME OF IMPLANTATION. THEN, AROUND THE END OF (B)(6) 2012, THE PT PRESENTED FOR IMAGING AS HE HAD UNK SHORTNESS OF BREATH. THE IMAGING ALLEGEDLY SHOWED THAT A LEG FROM ONE OF THE FILTERS HAD A BROKEN OFF AND EMBOLIZED TO HIS CHEST (B)(4). HOWEVER, ON OR ABOUT (B)(6) 2012, PT WAS INFORMED THAT BOTH OF HIS FILTERS WOULD NEED TO BE REMOVED BECAUSE HIS SVC FILTER HAD A FRACTURED LEG THAT HAD EMBOLIZED TO HIS LUNG AND BOTH FILTERS HAD SOME LEG PENETRATIONS (B)(4). FURTHER, THE PT WAS INFORMED THAT HIS FILTERS NEEDED TO BE REMOVED BECAUSE THEY MAY CONTINUE TO FRACTURE OVER TIME IF THEY WERE LEFT IN PLACE. THUS, THE PT UNDERWENT REMOVAL WHICH WAS COMPLEX BUT ULTIMATELY SUCCESSFUL. IT IS FURTHER ALLEGED THAT "THE FRACTURED STRUT FROM HIS SVC FILTER REMAINS IN THE LOWER LOBE OF HIS LUNG". PATIENT OUTCOME: IT IS ALLEGED THAT "FILTERS HAD BEEN THE CAUSE OF HIS PAIN AND SHORTNESS OF BREATH."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414974 COOK CELECT JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE E2417829

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Male Other| R| L