BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUNTHER TULIP FEMORAL VENA CAVA FILTER SET

    MDR report key: 6460232 · Received April 5, 2017

    Report

    Report Number
    1820334-2017-00725
    Event Type
    Injury
    Date Received
    April 5, 2017
    Date of Event
    January 25, 2011
    Report Date
    August 31, 2017
    Manufacturer
    COOK INC
    Product Code
    DTK
    PMA / PMN Number
    K090140
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    WILLIAM COOK EUROPE INITIALLY REPORTED EVENT UNDER MFR REPORT # 3002808486-2017-00858. 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.

    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 "PULMONARY EMBOLISM AFTER IMPLANT OF DEVICE AND UNABLE TO BE RETRIEVED". COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED. 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. 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

    THIS ADDITIONAL INFORMATION WAS RECEIVED ON 03/07/2017 AS FOLLOWS: THE PATIENT ALLEGEDLY RECEIVED DEVICE IMPLANT VIA RIGHT FEMORAL VEIN ON (B)(6) 2010 BY DUE TO DVT AND LARGE BILATERAL PES. THE PATIENT ALLEGES HAVING PULMONARY EMBOLISM AFTER IMPLANT OF DEVICE. PATIENT ALLEGES AN ATTEMPTED ROUTINE REMOVAL WAS PERFORMED ON (B)(6) 2011. THE [PT] ALLEGES THE REMOVAL ATTEMPT FAILED AND THAT HE STILL HAS BLOOD CLOTS IN EACH LUNG AS OF (B)(6) 2016. IT WAS REPORTED THAT THE DEVICE IS UNABLE TO BE RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243471 GUNTHER TULIP FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK INC

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Life Threatening