BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUNTHER TULIP JUGULAR VENA CAVA FILTER SET

    MDR report key: 7083793 · Received December 5, 2017

    Report

    Report Number
    1820334-2017-04284
    Event Type
    Injury
    Date Received
    December 5, 2017
    Report Date
    February 2, 2018
    Manufacturer
    COOK INC
    Product Code
    DTK
    PMA / PMN Number
    K072240
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE OR UNCHANGED. 510 (K) K072240. (B)(4). 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 'TILT, VENA CAVA PERFORATION, AORTIC PERFORATION'. 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. 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. UNABLE TO DETERMINE IF REPORTED ANXIETY IS RELATED TO FILTER AND UNABLE TO IDENTIFY CORRESPONDING FAILURE MODE 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. 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 · 0

    THIS ADDITIONAL INFORMATION RECEIVED ON 11DEC2017AS FOLLOWS: PATIENT ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2008 VIA THE RIGHT INTERNAL JUGULAR VEIN DUE TO ACUTE DEEP VEIN THROMBOSIS WITHIN THE RIGHT LOWER EXTREMITY AND COMMON FEMORAL VEIN. PATIENT IS ALLEGING TILT, VENA CAVA PERFORATION, AND AORTIC PERFORATION. PATIENT FURTHER ALLEGES ANXIETY.

    Additional Manufacturer Narrative · 1

    THE EVENT IS CURRENTLY UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE PROVIDED UPON CONCLUSION.

    Additional Manufacturer Narrative · 1

    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 FOL LOWS: PATIENT ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2008 VIA THE RIGHT INTERNAL JUGULAR VEIN DUE TO ACUTE DEEP VEIN THROMBOSIS WITHIN THE RIGHT LOWER EXTREMITY AND COMMON FEMORAL VEIN. PATIENT IS ALLEGING TILT, VENA CAVA PERFORATION, AND AORTIC PERFORATION.

    Description of Event or Problem · 1

    IT IS ALLEGED THAT THE PLAINTIFF RECEIVED A GUNTHER FILTER ON (B)(6) 2008. 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
    863057 GUNTHER TULIP JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| O