BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUNTHER TULIP JUGULAR VENA CAVA FILTER SET

    MDR report key: 6604676 · Received June 1, 2017

    Report

    Report Number
    1820334-2017-01344
    Event Type
    Injury
    Date Received
    June 1, 2017
    Report Date
    August 16, 2017
    Manufacturer
    COOK INC
    Product Code
    DTK
    UDI-DI
    10827002330174
    PMA / PMN Number
    K072240
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT IS CURRENTLY UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE PROVIDED UPON CONCLUSION. WILLIAM COOK EUROPE INITIALLY REPORTED EVENT UNDER MANUFACTURER REPORT # 3002808486-2016-00430. NEW INFORMATION WAS RECEIVED IDENTIFYING THAT THE PRODUCT WAS A COOK INC.

    Additional Manufacturer Narrative · 1

    INVESTIGATIVE EVALUATION- IT HAS NOT BEEN POSSIBLE TO FURTHER INVESTIGATE OR EVALUATE THIS ALLEGED EVENT BASED ON THE LIMITED INFORMATION PROVIDED TO DATE VIA THE OPERATIVE NOTE STATING "PLAINTIFF IS ALLEGING DEVICE IS UNABLE TO BE RETRIEVED, EMBEDDED, PAIN¿. COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED WARRANTING SUPPLEMENTATION IN ACCORDANCE WITH 21 C.F.R. 803.56. UNKNOWN IF THE REPORTED ¿PAIN¿ IS DIRECTLY RELATED TO THE FILTER AND UNABLE TO IDENTIFY A CORRESPONDING FAILURE MODE AT THIS POINT IN TIME. 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. 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.

    Description of Event or Problem · 1

    PLAINTIFF ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2011 VIA THE RIGHT INTERNAL JUGULAR VEIN DUE TO DEEP VEIN THROMBOSIS (DVT), PULMONARY EMBOLISM (PE) HIGH RISK FOR BLEEDING COMPLICATIONS FROM ANTICOAGULATION. PLAINTIFF ALLEGES ATTEMPTED RETRIEVAL ON (B)(6) 2012 AND (B)(6) 2012. PLAINTIFF IS ALLEGING DEVICE IS UNABLE TO BE RETRIEVED, EMBEDDED, PAIN. ADDITIONAL INFORMATION PROVIDED DETERMINED THAT THIS DEVICE WAS MANUFACTURED BY COOK INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387319 GUNTHER TULIP JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK INC G33017 10827002330174

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR