BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUNTHER TULIP FEMORAL VENA CAVA FILTER SET

    MDR report key: 6569472 · Received May 16, 2017

    Report

    Report Number
    1820334-2017-01033
    Event Type
    Injury
    Date Received
    May 16, 2017
    Date of Event
    January 25, 2011
    Report Date
    August 31, 2017
    Manufacturer
    COOK INC
    Product Code
    DTK
    PMA / PMN Number
    K043509
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) INITIALLY REPORTED EVENT UNDER MFR REPORT #3002808486-2017-00844 NEW INFORMATION WAS RECEIVED IDENTIFYING THAT THE PRODUCT WAS A COOK INC. THE ORIGINAL DATE OF AWARENESS IS 03/09/2017, IT WAS NOTED ON 05/10/2017 THE ALLEGED DEVICE IS A COOK INC DEVICE. THE EVENT IS CURRENTLY UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE PROVIDED UPON CONCLUSION.

    Additional Manufacturer Narrative · 1

    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, UNABLE TO RETRIEVE, CLOT IN FILTER, IMPROPER BLOOD FLOW: LE SWELLING, IMPAIRED SEXUAL RELATIONS'. COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED. 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. IVC THROMBOTIC OCCLUSION AS AN OUTCOME FOR COOK IVC FILTERS IS ADDRESSED IN THE PUBLISHED SCIENTIFIC LITERATURE. IVC THROMBOTIC OCCLUSION IS DEFINED AS THE PRESENCE OF AN OCCLUDING THROMBUS IN THE IVC AFTER FILTER INSERTION AND DOCUMENTED BY ULTRASOUND (US), CT, MR IMAGING OR VENOGRAPHY; THIS MAY BE SYMPTOMATIC OR ASYMPTOMATIC. UNKNOWN IF THE REPORTED IMPROPER BLOOD FLOW: LE SWELLING, IMPAIRED SEXUAL RELATIONS IS DIRECTLY RELATED TO THE FILTER AND UNABLE TO IDENTIFY A CORRESPONDING FAILURE MODE 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.

    Description of Event or Problem · 1

    PLAINTIFF ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2010 VIA THE FEMORAL VEIN DUE TO THE INABILITY TO ANTICOAGULATE. PLAINTIFF ALLEGEDLY HAD A REMOVAL (UNSUCCESSFUL) ATTEMPT (B)(6) 2011 BUT PROCEDURE NOTES STATE THAT THERE WAS EVIDENCE OF CHRONIC SCARRING AND CLOT BURDEN IN THE FILTER' AND THEREFORE ABANDONED THE REMOVAL ATTEMPT. PLAINTIFF IS ALLEGING DEVICE IS UNABLE TO BE RETRIEVED, OTHER: UNNECESSARY PROCEDURE, OTHER: SWELLING IN LOWER LIMBS, OTHER: IMPROPER BLOOD FLOW, OTHER: IMPAIRED SEXUAL RELATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350265 GUNTHER TULIP FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK INC

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Life Threatening