BEUDAMED
    FDA Adverse Event Death Summary report: N

    GUNTHER TULIP FEMORAL VENA CAVA FILTER SET

    MDR report key: 7727997 · Received July 27, 2018

    Report

    Report Number
    1820334-2018-02314
    Event Type
    Death
    Date Received
    July 27, 2018
    Report Date
    August 17, 2018
    Manufacturer
    COOK INC
    Product Code
    DTK
    PMA / PMN Number
    K043509
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS REOPENED DUE TO ADDITIONAL INFORMATION PROVIDED. 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, EMOTIONAL DISTRESS, DECLINING HEALTH, PATIENT DEATH'. 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 PATIENT DEATH IS RELATED TO THE FILTER. 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. UNKNOWN IF THE REPORTED EMOTIONAL DISTRESS AND DECLINING HEALTH IS DIRECTLY RELATED TO THE FILTER AND UNABLE TO IDENTIFY CORRESPONDING FAILURE MODE(S) AT THIS TIME. NO OTHER COMPLAINTS ON LOT. PRODUCT IS MANUFACTURED ACCORDING TO SPECIFICATIONS. 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

    (B)(4). WILLIAM COOK EUROPE INITIALLY REPORTED EVENT UNDER MANUFACTURER REPORT #3002808486-2017-01982. NEW INFORMATION WAS RECEIVED IDENTIFYING THAT THE PRODUCT WAS A COOK INC. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    NO ADDITIONAL INFORMATION REPORTED AT THIS TIME.

    Description of Event or Problem · 1

    THIS ADDITIONAL INFORMATION RECEIVED ON 29JUL2018 AS FOLLOWS: PATIENT ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2014 VIA THE LEFT COMMON FEMORAL VEIN DUE TO DEEP VEIN THROMBOSIS. IT IS ALLEGED THE DEVICE IS UNABLE TO BE RETRIEVED, "LONG TERM IMPLANT HAS CAUSED EMOTIONAL DISTRESS AND DECLINING HEALTH ATTRIBUTING TO PATIENT'S DEATH" . NO FURTHER EXPLANATION REGARDING PATIENT¿S DEATH WAS PROVIDED, BUT HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569850 GUNTHER TULIP FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK INC 4624932

    Patients

    Seq Age Sex Outcome Treatment
    1 Death