BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUNTHER TULIP FEMORAL VENA CAVA FILTER SET

    MDR report key: 7515485 · Received May 15, 2018

    Report

    Report Number
    1820334-2018-01493
    Event Type
    Malfunction
    Date Received
    May 15, 2018
    Date of Event
    June 16, 2010
    Report Date
    June 13, 2018
    Manufacturer
    COOK INC
    Product Code
    DTK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    WILLIAM COOK EUROPE INITIALLY REPORTED EVENT UNDER MANUFACTURER REPORT #: 3002808486-2016-00515. NEW INFORMATION WAS RECEIVED IDENTIFYING THAT THE PRODUCT WAS A COOK INC. (B)(4). THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Additional Manufacturer Narrative · 1

    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 ¿UNABLE TO RETRIEVE, EMBEDMENT, PAIN, ANXIETY". COOK WILL REOPEN ITS INVESTIGATION AFTER FURTHER INFORMATION CONCERNING ALLEGED PATIENT SUFFERINGS IS RECEIVED AND WILL SUPPLEMENT IN ACCORDANCE WITH 21 C.F.R.803.56 WHEN APPROPRIATE. A FILTER THAT IS EMBEDDED IN THE WALL OF THE IVC MAY BE DIFFICULT TO RETRIEVE. 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 PAIN IS DIRECTLY RELATED TO THE FILTER. UNKNOWN IF THE REPORTED ANXIETY IS DIRECTLY RELATED TO THE FILTER AND UNABLE TO IDENTIFY A CORRESPONDING FAILURE MODE AT THIS POINT IN 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

    PT ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2009 VIA THE COMMON FEMORAL VEIN DUE TO MOTOR VEHICLE COLLISION INTRACRANIAL INJURY WITH INTRACRANIAL HEMORRHAGE AND INABILITY TO RECEIVE ANTICOAGULATION FOR DEEP VEIN THROMBOSIS PROPHYLAXIS. PT ALLEGES DEVICE UNABLE TO RETRIEVE, EMBEDMENT (CAVAL WALL). PT FURTHER ALLEGES PAIN, ANXIETY. UNSUCCESSFUL FILTER RETRIEVAL ATTEMPT ON (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356261 GUNTHER TULIP FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK INC

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR