BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GUNTHER TULIP FEMORAL VENA CAVA FILTER SET

    MDR report key: 7300632 · Received February 27, 2018

    Report

    Report Number
    1820334-2018-00506
    Event Type
    Injury
    Date Received
    February 27, 2018
    Report Date
    June 18, 2018
    Manufacturer
    COOK INC
    Product Code
    DTK
    PMA / PMN Number
    K043509
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 0

    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 'TILT, ORGAN PERFORATION-MESENTERIC, 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. 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. UNKNOWN IF THE REPORTED ANXIETY IS DIRECTLY RELATED TO THE FILTER AND UNABLE TO IDENTIFY CORRESPONDING FAILURE MODE(S) AT THIS 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. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED. 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 'TILT, ORGAN PERFORATION-MESENTERIC, 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. 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. UNKNOWN IF THE REPORTED ANXIETY IS DIRECTLY RELATED TO THE FILTER AND UNABLE TO IDENTIFY CORRESPONDING FAILURE MODE(S) AT THIS 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. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. VESSELS, PERFORATION OF (2135), NOT LISTED IN IFU THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    THIS ADDITIONAL INFORMATION RECEIVED ON 24MAY2018 AS FOLLOWS: PT IS ALLEGING VENA CAVA PERFORATION.

    Additional Manufacturer Narrative · 1

    WILLIAM COOK EUROPE INITIALLY REPORTED EVENT UNDER MANUFACTURER REPORT #3002808486-2017-02454. NEW INFORMATION WAS RECEIVED IDENTIFYING THAT THE PRODUCT WAS A COOK INC. (B)(4). PMA/510 (K) K043509. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    ¿[PT] ALLEGEDLY RECEIVED AN IMPLANT ON (B)(6) 2011 VIA THE RIGHT COMMON FEMORAL VEIN DUE TO PULMONARY EMBOLISM . [PT] IS ALLEGING TILT, ORGAN PERFORATION-MESENTERIC. [PT] FURTHER ALLEGES ANXIETY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142698 GUNTHER TULIP FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK INC 2534371

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening