BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUNTHER TULIP FEMORAL VENA CAVA FILTER SET

    MDR report key: 6901102 · Received September 28, 2017

    Report

    Report Number
    1820334-2017-03451
    Event Type
    Injury
    Date Received
    September 28, 2017
    Report Date
    October 17, 2017
    Manufacturer
    COOK INC
    Product Code
    DTK
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 ¿FAILED TO PREVENT PE". COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED WARRANTING SUPPLEMENTATION IN ACCORDANCE WITH 21 C.F.R. 803.56. PE IS A KNOWN RISK IN RELATION TO FILTER IMPLANT REPORTED IN THE PUBLISHED SCIENTIFIC LITERATURE. ALSO, IT IS REPORTED THAT THE PULMONARY EMBOLISM IN SOME CASES MAY ORIGINATE FROM UPPER EXTREMITIES INSTEAD OF LOWER EXTREMITY VEINS. WITH ALL FILTERS, THERE IS SOME RISK OF FURTHER PULMONARY EMBOLISM. NO EVIDENCE TO SUGGEST PRODUCT WAS NOT MANUFACTURED TO SPECIFICATION.

    Additional Manufacturer Narrative · 1

    CORRECTION: ADDITIONAL INFORMATION PROVIDED DETERMINED THAT THIS DEVICE WAS MANUFACTURED BY COOK INC. WITH THE SUBMISSION OF THIS FOLLOW UP REPORT, WILLIAM COOK EUROPE INFORMS THAT THIS COMPLAINT HAS BEEN TRANSFERRED FROM WILLIAM COOK EUROPE TO COOK INC.

    Description of Event or Problem · 1

    PLAINTIFF ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2010 VIA THE LEFT FEMORAL VEIN DUE TO DVT AND PE DESPITE ADEQUATE ANTICOAGULATIVE THERAPY. PER MEDICAL RECORDS, PATIENT IS EXPERIENCING A SMALL VOLUME OF RECURRENT PE DESPITE IVC FILTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680340 GUNTHER TULIP FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening