BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GUNTHER TULIP NAVALIGN JUGULAR VENA CAVA FILTER SET

    MDR report key: 20531483 · Received October 25, 2024

    Report

    Report Number
    3002808486-2024-00228
    Event Type
    Malfunction
    Date Received
    October 25, 2024
    Date of Event
    August 19, 2024
    Report Date
    October 25, 2024
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF# (B)(4). BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. G4) SIMILAR TO DEVICE MARKETED UNDER PMA/510(K): K233680. AFTER INVESTIGATION COMPLETED 11OCT2024, EVENT IS CONSIDERED REPORTABLE. SUMMARY OF INVESTIGATIONAL FINDINGS: THE INTRODUCER SHEATH WAS DAMAGED DURING RETRIEVAL OF A TULIP FILTER, WHICH WOULD NOT COLLAPSE FROM THE VENA CAVA WALL (THIS COMPLAINT). THE FILTER WAS SUCCESSFULLY RETRIEVED WITH ANOTHER GTRS. THE FILTER WAS NOT RETURNED FOR ANALYSIS AND NO IMAGING WAS PROVIDED. THEREFORE, BASED ON THE INFORMATION PROVIDED ONLY THE EXACT REASON FOR THE DIFFICULTIES IN COLLAPSING AND RETRIEVING THE FILTER IN THE FIRST ATTEMPT CANNOT BE DETERMINED. PHYSICIAN PRACTICE GUIDELINES AND PUBLISHED GUIDANCE FROM REGULATORY AGENCIES RECOMMEND THAT PATIENTS WITH INDWELLING FILTERS UNDERGO ROUTINE FOLLOW-UP. THE RISKS/BENEFITS OF FILTER RETRIEVAL SHOULD BE CONSIDERED FOR EACH PATIENT DURING FOLLOW-UP. ONCE PROTECTION FROM PULMONARY EMBOLISM (PE) IS NO LONGER NECESSARY, FILTER RETRIEVAL SHOULD BE CONSIDERED. FILTER RETRIEVAL SHOULD BE ATTEMPTED WHEN FEASIBLE AND CLINICALLY INDICATED. FILTER RETRIEVAL IS A PATIENT-SPECIFIC, CLINICALLY COMPLEX DECISION. THE DECISION TO REMOVE A FILTER SHOULD BE BASED ON EACH PATIENT¿S INDIVIDUAL RISK/BENEFIT PROFILE (E.G., A PATIENT¿S CONTINUED NEED FOR PROTECTION FROM PE COMPARED TO THEIR EXPERIENCE WITH AND (OR) ONGOING RISK OF EXPERIENCING FILTER-RELATED COMPLICATIONS). THE FILTER IS DESIGNED TO BE RETRIEVED WITH THE GÜNTHER TULIP VENA CAVA FILTER RETRIEVAL SET. IT MAY ALSO BE RETRIEVED WITH THE CLOVERSNARE® VASCULAR RETRIEVER. COOK HAS NOT PERFORMED TESTING TO EVALUATE THE SAFETY OR EFFECTIVENESS OF FILTER RETRIEVAL USING OTHER RETRIEVAL SYSTEMS OR TECHNIQUES. THE PUBLISHED CLINICAL LITERATURE INCLUDES DESCRIPTIONS OF ALTERNATIVE TECHNIQUES FOR FILTER RETRIEVAL; USE OF THESE TECHNIQUES VARIES ACCORDING TO PHYSICIAN EXPERIENCE, PATIENT ANATOMY, AND FILTER POSITION. THE SAFETY OR EFFECTIVENESS OF THESE ALTERNATIVE RETRIEVAL TECHNIQUES HAS NOT BEEN ESTABLISHED. COOK WAS UNABLE TO CONDUCT A REVIEW OF THE DEVICE HISTORY RECORD, AS THE LOT NUMBER OF THE COMPLAINT DEVICE WAS NOT PROVIDED FOR THE INVESTIGATION. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21CFR 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

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: PRIMARY DISEASE: DVT (DEEP VEIN THROMBOSIS). FOR RETRIEVAL OF AN INFERIOR VENA CAVA (IVC) FILTER, AN APPROACH WAS MADE VIA THE RIGHT INTERNAL JUGULAR VEIN. AFTER INSERTING THE SHEATH AND GRASPING THE FILTER HOOK WITH THE SNARE, THE SHEATH SYSTEM WAS PUSHED FORWARD WHILE FIXING THE LOOP SYSTEM, BUT THE LEGS OF THE FILTER DID NOT SEPARATE FROM THE BLOOD VESSEL WALL. AFTER REPEATING THIS PROCESS SEVERAL TIMES, THE PROXIMAL PART OF THE OUTER SHEATH (BLUE) BECAME WRINKLED AND SHRUNK, AND THE SHEATH SYSTEM HAD TO BE REMOVED. THE PROCEDURE WAS COMPLETED BY RETRIEVING THE FILTER WITH ANOTHER GTRS-200-RB (LOT# UNKNOWN). THE IVC FILTER HAD BEEN PLACED FOR ONE MONTH. PATIENT OUTCOME: NO ADVERSE EFFECT ON THE PATIENT HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1568547 GUNTHER TULIP NAVALIGN JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE G52916 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Unknown