BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUNTHER TULIP JUGULAR VENA CAVA FILTER SET

    MDR report key: 7008964 · Received November 8, 2017

    Report

    Report Number
    1820334-2017-03882
    Event Type
    Malfunction
    Date Received
    November 8, 2017
    Report Date
    April 17, 2019
    Manufacturer
    COOK INC
    Product Code
    DTK
    UDI-DI
    10827002330174
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    WILLIAM COOK EUROPE INITIALLY REPORTED EVENT UNDER MFR REPORT # 1820344-2017-03883. 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

    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 'VENA CAVA PERFORATION, PAIN IN- KNEES, HIP, SIDE, ABDOMEN, BACK'. 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. WHILE PAIN IN KNEES, HIP, SIDE ABDOMEN AND BACK IS REPORTED, WE ARE UNABLE TO IDENTIFY A CORRESPONDING FAILURE MODE AT THIS TIME. (B)(4) 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.

    Additional Manufacturer Narrative · 1

    PER QUALITY ENGINEERING REVIEW, THE ADDITIONAL INFORMATION PROVIDED FOR THIS COMPLAINT DOES NOT CHANGE THE PREVIOUS INVESTIGATION CONCLUSION. THEREFORE, NO NEW INVESTIGATION ACTIVITIES WILL BE CONDUCTED AT THIS TIME. COOK WILL REOPEN ITS INVESTIGATION IF FURTHER INFORMATION IS RECEIVED WARRANTING SUPPLEMENTATION IN ACCORDANCE WITH 21 C.F.R. 803.56.

    Description of Event or Problem · 1

    PATIENT RECEIVED AN IMPLANT ON (B)(6) 2011 VIA THE RIGHT INTERNAL JUGULAR VEIN DUE TO PULMONARY EMBOLISM, PRE-OP HIP SURGERY. PATIENT IS ALLEGING VENA CAVA PERFORATION, PAIN IN- KNEES, HIP, SIDE, ABDOMEN, BACK. WITHOUT FURTHER DETAILS.

    Description of Event or Problem · 1

    PER PHYSICIAN'S REVIEW OF ABDOMINAL CT, DATED (B)(6) 2017, "POSITIVE FOR CAVAL PERFORATION. SUPERIOR IVC FILTER AT THE L 1-L2 DISC SPACE, INFERIOR IVC FILTER MID BODY OF L3. NO EVIDENCE OF MIGRATION. NO TILT OF IVC. AT LEAST FOUR PRONGS OF IVC FILTER HAVE PERFORATED IVC."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    788277 GUNTHER TULIP JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK INC G33017 10827002330174

    Patients

    Seq Age Sex Outcome Treatment
    1