BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUNTHER TULIP JUGULAR VENA CAVA FILTER SET

    MDR report key: 8627548 · Received May 21, 2019

    Report

    Report Number
    1820334-2019-01221
    Event Type
    Malfunction
    Date Received
    May 21, 2019
    Report Date
    May 21, 2019
    Manufacturer
    COOK INC
    Product Code
    DTK
    UDI-DI
    10827002330174
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PREVIOUS MDR WAS SUBMITTED BY WILLIAM COOK EUROPE UNDER MANUFACTURER REPORT REFERENCE# 3002808486-2019-00150. ADDITIONAL INFORMATION PROVIDED DETERMINED THAT THIS DEVICE WAS MANUFACTURED BY COOK INC. WITH THE SUBMISSION OF THIS INITIAL REPORT, COOK INC. INFORMS THAT ALL FUTURE SUBMISSIONS REGARDING THIS COMPLAINT WILL BE HANDLED UNDER MANUFACTURER REPORT REFERENCE# 1820334-2019-01221. OCCUPATION: NON-HEALTHCARE PROFESSIONAL. PMA/510(K) #: K072240. INVESTIGATION: INVESTIGATION IS REOPENED DUE TO ADDITIONAL INFORMATION PROVIDED. THE FOLLOWING ALLEGATIONS HAVE BEEN INVESTIGATED: TILT, DISABILITY. THE REPORTED ALLEGATIONS HAVE BEEN FURTHER INVESTIGATED BASED ON THE INFORMATION PROVIDED TO DATE. FILTER TILT HAS BEEN REPORTED. POTENTIAL CAUSES MAY INCLUDE FILTER PLACEMENT IN IVCS WITH DIAMETERS LARGER THAN THOSE SPECIFIED IN THESE INSTRUCTIONS FOR USE; IMPROPER DEPLOYMENT; MANIPULATIONS NEAR AN IMPLANTED FILTER (E.G., A SURGICAL OR ENDOVASCULAR PROCEDURE IN THE VICINITY OF A FILTER); AND (OR) A FAILED RETRIEVAL ATTEMPT. EXCESSIVE FILTER TILT MAY CONTRIBUTE TO DIFFICULT OR FAILED RETRIEVAL; VENA CAVA WALL PENETRATION/PERFORATION; AND (OR) RESULT IN LOSS OF FILTER EFFICIENCY. POTENTIAL ADVERSE EVENTS THAT MAY OCCUR INCLUDE, BUT ARE NOT LIMITED TO, THE FOLLOWING: UNACCEPTABLE FILTER TILT. UNKNOWN IF THE REPORTED DISABILITY IS DIRECTLY RELATED TO THE FILTER AND UNABLE TO IDENTIFY A CORRESPONDING FAILURE MODE AT THIS POINT IN TIME. PRODUCT IS MANUFACTURED AND INSPECTED ACCORDING TO SPECIFICATIONS. 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 WARRANTING SUPPLEMENTATION IN ACCORDANCE WITH 21 C.F.R. 803.56.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT ALLEGEDLY RECEIVED A GUNTHER TULIP JUGULAR VENA CAVA FILTER IMPLANT ON (B)(6) 2011 DUE TO AN ORTHOPEDIC PROCEDURE. THE PATIENT IS ALLEGING TILT. THE PATIENT FURTHER ALLEGES NO LONGER PARTICIPATING IN REGULAR EXERCISE OR ACTIVITIES THAT REQUIRE LIFTING OR REGULARLY ENGAGING IN STRENUOUS ACTIVITY. ADDITIONALLY, IT WAS REPORTED THAT PER THE (B)(6) 2018, COMPUTED TOMOGRAPHY-ABDOMEN AND PELVIS WITHOUT CONTRAST: "INFERIOR VENA CAVA FILTER IS IN PLACE. THE TIP OF THE FILTER PROJECTS TOWARDS THE RIGHT AND IS AT THE LEVEL OF THE RENAL VEINS".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421146 GUNTHER TULIP JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK INC G33017 2759938 10827002330174

    Patients

    Seq Age Sex Outcome Treatment
    1