BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUNTHER TULIP FEMORAL VENA CAVA FILTER SET

    MDR report key: 7083736 · Received December 5, 2017

    Report

    Report Number
    1820334-2017-04283
    Event Type
    Injury
    Date Received
    December 5, 2017
    Report Date
    February 1, 2018
    Manufacturer
    COOK INC
    Product Code
    DTK
    PMA / PMN Number
    K043509
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED : ADVERSE EVENT TO ADVERSE EVENT AND PRODUCT PROBLEM. 510K: K043509. (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION.

    Additional Manufacturer Narrative · 1

    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 'TULIP, TILT, VENA CAVA AND ORGAN PERFORATION, DEVICE UNABLE TO RETRIEVE, EMBEDMENT, ANXIETY'. COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED WARRANTING SUPPLEMENTATION IN ACCORDANCE WITH 21 C.F.R. 803.56. VENA CAVA WALL PERFORATION IS A KNOWN POTENTIAL COMPLICATION OF VENA CAVA FILTERS. BOTH SYMPTOMATIC AND ASYMPTOMATIC EVENTS HAVE BEEN REPORTED. AMONG OTHER CAUSES, VENA CAVA WALL PERFORATION MAY INADVERTENTLY BE INITIATED BY IMPROPER DEPLOYMENT, EXCESSIVE FORCE OR MANIPULATIONS NEAR AN IMPLANTED FILTER (E.G., A SURGICAL PROCEDURE IN THE VICINITY OF A FILTER) AND (OR) PROCEDURES THAT INVOLVE OTHER DEVICES BEING PASSED THROUGH AN IN SITU FILTER. THERE IS A CURRENT DEBATE IN THE PUBLISHED SCIENTIFIC LITERATURE ON A DIFFERENTIATION BETWEEN IVC WALL PERFORATION WITH AND WITHOUT CLINICAL SEQUELAE. E.G. FILTER LEGS MAY BE OUTSIDE THE CONTRAST LUMEN ON IMAGING WITHOUT ACTUALLY PERFORATING THE IVC WALL (KNOWN AS TENTING) AND WITH NO CLINICAL SEQUELAE. IN CONTRAST, PERFORATION OF ADJACENT ORGANS IS REPORTED WITH CLINICAL SEQUELAE. 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. FILTER TILT IS A KNOWN RISK IN RELATION TO FILTER IMPLANT REPORTED IN THE PUBLISHED SCIENTIFIC LITERATURE AND MAY OCCUR DURING PLACEMENT OR DURING IMPLANTING PERIOD. IT IS UNKNOWN IF THE REPORTED ANXIETY IS DIRECTLY RELATED TO THE FILTER AND UNABLE TO IDENTIFY CORRESPONDING FAILURE MODE(S) AT THIS TIME. NO RELEVANT NOTES FOUND IN DEVICE WORK ORDER. NO OTHER COMPLAINTS FOUND IN DEVICE LOT. PRODUCT IS MANUFACTURED AND INSPECTED ACCORDING TO MANUFACTURING INSTRUCTIONS AND QUALITY CONTROL. THERE IS 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). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION.

    Description of Event or Problem · 1

    THIS ADDITIONAL INFORMATION RECEIVED ON 11DEC2017 AS FOLLOWS: [PT] ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2006 VIA THE RIGHT COMMON FEMORAL VEIN DUE TO PRIOR DEEP VEIN THROMBOSIS AND PULMONARY EMBOLISM, PREOP FOR KNEE SURGERY. PT IS ALLEGING TILT, VENA CAVA PERFORATION, DEVICE UNABLE TO BE RETRIEVED, ORGAN PERFORATION (MESENTERIC), EMBEDMENT, ANXIETY. ATTEMPTED DEVICE RETRIEVAL ON (B)(6) 2006, RETRIEVAL WAS UNSUCCESSFUL.

    Description of Event or Problem · 1

    IT IS ALLEGED THAT THE PLAINTIFF RECEIVED A GUNTHER FILTER ON (B)(6) 2006. IT IS ALLEGED THAT THE PLAINTIFF WAS INJURED WITHOUT FURTHER EXPLANATION. HOSPITAL AND MEDICAL RECORDS HAVE BEEN REQUESTED BUT NOT YET PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861846 GUNTHER TULIP FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| O