BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUNTHER TULIP FEMORAL VENA CAVA FILTER SET

    MDR report key: 6537153 · Received May 2, 2017

    Report

    Report Number
    1820334-2017-00967
    Event Type
    Injury
    Date Received
    May 2, 2017
    Date of Event
    September 20, 2011
    Report Date
    May 30, 2019
    Manufacturer
    COOK INC
    Product Code
    DTK
    PMA / PMN Number
    K043509
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    WILLIAM COOK (B)(4) INITIALLY REPORTED EVENT UNDER MFR REPORT #3002808486-2017-00840. NEW INFORMATION WAS RECEIVED IDENTIFYING THAT THE PRODUCT WAS A COOK INC. MANUFACTURED DEVICE. (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE PROVIDED UPON CONCLUSION.

    Additional Manufacturer Narrative · 1

    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, DEVICE UNABLE TO BE RETRIEVED, EMBEDDED, SHORTNESS OF BREATH, LIGHT HEADED, HEADACHES". COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED. 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. 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 "SHORTNESS OF BREATH, LIGHT HEADED AND HEADACHES" ARE 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

    THE FOLLOWING ALLEGATIONS HAVE BEEN INVESTIGATED: VC/ORGAN PERFORATION, EMBEDDED. INVESTIGATION IS REOPENED DUE TO ADDITIONAL INFORMATION PROVIDED. THE REPORTED ALLEGATIONS HAVE BEEN FURTHER INVESTIGATED BASED ON THE INFORMATION PROVIDED TO DATE. VENA CAVA WALL PENETRATION/PERFORATION HAS BEEN REPORTED AND MAY BE EITHER SYMPTOMATIC OR ASYMPTOMATIC. POTENTIAL CAUSES MAY INCLUDE IMPROPER DEPLOYMENT; AND (OR) EXCESSIVE FORCE OR MANIPULATIONS NEAR AN IN-SITU FILTER (E.G., A SURGICAL OR ENDOVASCULAR PROCEDURE IN THE VICINITY OF A FILTER). POTENTIAL ADVERSE EVENTS THAT MAY OCCUR INCLUDE, BUT ARE NOT LIMITED TO, THE FOLLOWING: TRAUMA TO ADJACENT STRUCTURES, VASCULAR TRAUMA, VENA CAVA PERFORATION, VENA CAVA PENETRATION. A FILTER THAT IS EMBEDDED IN THE WALL OF THE IVC MAY BE DIFFICULT TO RETRIEVE. FOR ALL RETRIEVABLE IVC FILTERS, RETRIEVAL BECOMES MORE CHALLENGING WITH TIME, AND THIS IS COMMONLY DUE TO ENCAPSULATION OF THE FILTER LEGS OR HOOK (IN A TILTED FILTER) BY TISSUE INGROWTH. 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. COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    PLAINTIFF ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2011 VIA THE COMMON FEMORAL VEIN DUE TO MOTOR VEHICLE ACCIDENT. PLAINTIFF ALLEGES ATTEMPTED RETRIEVAL ON (B)(6) 2011. PLAINTIFF IS ALLEGING TILT, DEVICE UNABLE TO BE RETRIEVED AS THE TIP OF IVC FILTER IS EMBEDDED IN THE WALL IS AND UNABLE TO SNARE. PLAINTIFF ALSO ALLEGES SHORTNESS OF BREATH, LIGHT HEADED, AND HEADACHES.

    Description of Event or Problem · 1

    DATED 23JUN2017, ABDOMINAL/PELVIC CT REPORTS, "AN IVC FILTER. NO EVIDENCE OF TILTING. ONE OF THE PRONGS EXTENDS INTO THE RIGHT PSOAS MUSCLE. NO THROMBOSIS. THE APEX OF THE FILTER IS SUPERIOR TO THE RENAL VEINS. THE ILIAC VEINS AND DISTAL IVC NOT OPACIFIED BY IV CONTRAST LIKELY DUE TO CONTRAST TIMING." DATED 07AUG2017, REVIEW OF ABDOMINAL/PELVIC CT REPORTS, "POSITIVE FOR CAVAL PERFORATION. SUPERIOR EXTENT OF IVC FILTER L 1-L2 DISC SPACE. INFERIOR EXTENT L2-L3 DISC SPACE. A TOTAL OF FOUR PRONGS PERFORATED THE IVC. MAXIMUM DISTANCE PRONG PERFORATED. CORONAL IMAGES SHOW APPROXIMATELY A 2-DEGREE TILT LEFT-TO-RIGHT. SAGITTAL IMAGES SHOW APPROXIMATELY 10 DEGREE TILT ANTERIOR POSTERIOR. AGAIN, PLEASE NOTE UNABLE TO MEASURE ANGLES. DIAMETER OF IVC DIRECTLY ABOVE FILTER 17 MM X 18 MM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318712 GUNTHER TULIP FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK INC

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Life Threatening