BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUNTHER TULIP JUGULAR VENA CAVA FILTER SET

    MDR report key: 6834208 · Received August 31, 2017

    Report

    Report Number
    1820334-2017-02845
    Event Type
    Malfunction
    Date Received
    August 31, 2017
    Report Date
    October 16, 2017
    Manufacturer
    COOK INC
    Product Code
    DTK
    PMA / PMN Number
    K072240
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    FILTER RETRIEVAL IS OCCASIONALLY DIFFICULT. THIS IS WELL-KNOWN FROM PUBLISHED SCIENTIFIC LITERATURE WHERE FILTER RETRIEVALS ARE REFERRED TO AS SIMPLE VS. COMPLEX. SEVERAL CASE REPORTS PUBLISHED IN SCIENTIFIC LITERATURE DESCRIBE COMPLEX CASES WITH SUCCESSFUL ENDOVASCULAR FILTER RETRIEVALS USING ADDITIONAL, ADVANCED TECHNIQUES. FILTER TILT IS A KNOWN RISK IN RELATION TO FILTER IMPLANT REPORTED IN THE PUBLISHED SCIENTIFIC LITERATURE AND MAY OCCUR DURING PLACEMENT OR DURING IMPLANTING PERIOD. UNKNOWN IF THE REPORTED CHEST, PELVIC + RIGHT SHOULDER PAIN IS DIRECTLY RELATED TO THE FILTER AND UNABLE TO IDENTIFY CORRESPONDING FAILURE MODE(S) AT THIS TIME. NO EVIDENCE TO SUGGEST THAT THIS DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS AND NOTHING INDICATES THAT THE FILTER DID NOT PERFORM AS INTENDED, E.G. INTENDED FOR THE PREVENTION OF RECURRENT PULMONARY EMBOLISM (PE) VIA PLACEMENT IN THE VENA CAVA.

    Additional Manufacturer Narrative · 1

    WILLIAM COOK (B)(4) INITIALLY REPORTED EVENT UNDER MFR REPORT # 3002808486-2017-01604. NEW INFORMATION WAS RECEIVED IDENTIFYING THAT THE PRODUCT WAS A COOK INC. MANUFACTURED DEVICE. (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE PROVIDED UPON CONCLUSION.

    Description of Event or Problem · 1

    PATIENT ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2010 VIA THE RIGHT INTERNAL JUGULAR VEIN DUE TO BILATERAL PULMONARY EMBOLI. PATIENT IS ALLEGING TILT, DEVICE IS UNABLE TO BE RETRIEVED, EMBEDDED; CHEST, PELVIC, AND RIGHT SHOULDER PAIN WITHOUT FURTHER DETAILS. NO RETRIEVAL ATTEMPTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614355 GUNTHER TULIP JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK INC

    Patients

    Seq Age Sex Outcome Treatment
    1