BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUNTHER TULIP FEMORAL VENA CAVA FILTER SET

    MDR report key: 7133913 · Received December 20, 2017

    Report

    Report Number
    1820334-2017-04669
    Event Type
    Malfunction
    Date Received
    December 20, 2017
    Report Date
    January 26, 2018
    Manufacturer
    COOK INC
    Product Code
    DTK
    UDI-DI
    10827002330167
    PMA / PMN Number
    K043509
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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 'IN PLACE MORE THAN 90 DAYS AND TOO RISKY TO ATTEMPT RETRIEVAL; FEAR OF MIGRATION OR FRACTURE'. COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED WARRANTING SUPPLEMENTATION IN ACCORDANCE WITH 21 C.F.R. 803.56. 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 FEAR OF MIGRATION OR FRACTURE 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.

    Additional Manufacturer Narrative · 1

    WILLIAM COOK (B)(4) INITIALLY REPORTED EVENT UNDER MANUFACTURER REPORT #3002808486-2017-01938. NEW INFORMATION WAS RECEIVED IDENTIFYING THAT THE PRODUCT WAS A COOK INC. (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE PROVIDED UPON CONCLUSION.

    Description of Event or Problem · 1

    PATIENT RECEIVED AN IMPLANT ON (B)(6) 2012 VIA THE RIGHT COMMON FEMORAL VEIN DUE TO UPCOMING BACK SURGERY. PATIENT ALLEGING THAT THE FILTER HAS BEEN IN PLACE MORE THAN 90 DAYS AND IT'S TOO RISKY TO ATTEMPT RETRIEVAL WITHOUT PROVIDING FURTHER DETAILS. PATIENT IS ALLEGING TO HAVE FEAR OF POTENTIAL MIGRATION AND OR FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    915171 GUNTHER TULIP FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK INC G33016 10827002330167

    Patients

    Seq Age Sex Outcome Treatment
    1