BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUNTHER TULIP JUGULAR & FEMORAL VENA CAVA FILTER SET

    MDR report key: 6587053 · Received May 24, 2017

    Report

    Report Number
    1820334-2017-01250
    Event Type
    Injury
    Date Received
    May 24, 2017
    Report Date
    September 27, 2017
    Manufacturer
    COOK INC
    Product Code
    DTK
    UDI-DI
    10827002213606
    PMA / PMN Number
    K072240
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED FROM ADVERSE EVENT TO ADVERSE EVENT AND PRODUCT PROBLEM. ADDITIONAL INFORMATION INVESTIGATION - 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, "TULIP, DEVICE IS UNABLE TO BE RETRIEVED, BLEEDING." 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 DEVICE IS UNABLE TO BE RETRIEVED AND BLEEDING 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.

    Additional Manufacturer Narrative · 1

    THE EVENT IS CURRENTLY UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE PROVIDED UPON CONCLUSION. (B)(4).

    Description of Event or Problem · 1

    IT IS ALLEGED THAT [PT] RECEIVED A GUNTHER TULIP FILTER ON (B)(6) 2015. THIS ADDITIONAL INFORMATION RECEIVED ON APRIL 27, 2017 AS FOLLOWS: PLAINTIFF ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2015 VIA THE RIGHT FEMORAL VEIN DUE TO LEFT COMMON FEMORAL VEIN DEEP VEIN THROMBOSIS (DVT) AND PULMONARY EMBOLISM (PE). PLAINTIFF IS ALLEGING DEVICE IS UNABLE TO BE RETRIEVED AND BLEEDING. ADDITIONAL INFORMATION PROVIDED DETERMINED THAT THIS DEVICE WAS MANUFACTURED BY COOK INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369782 GUNTHER TULIP JUGULAR & FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK INC G21360 10827002213606

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening