BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET

    MDR report key: 21215778 · Received January 23, 2025

    Report

    Report Number
    3002808486-2025-00017
    Event Type
    Injury
    Date Received
    January 23, 2025
    Date of Event
    October 22, 2024
    Report Date
    January 23, 2025
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    UDI-DI
    10827002355818
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF#: (B)(4). G4) 510(K): K233680. EVENT BECAME REPORTABLE AFTER COMPLETIONS OF INVESTIGATION 22JAN2025. SUMMARY OF INVESTIGATIONAL FINDINGS: AN ATTEMPT TO RETRIEVE A CELECT-PT FILTER ONE MONTH AFTER PLACEMENT FAILED, AS THE NON-COOK RETRIEVAL DEVICE COULD NOT CATCH THE FILTER HOOK. THERE IS NO INFORMATION AS TO A SECOND RETRIEVAL ATTEMPT. NO COMPLAINT DEVICE WAS RETURNED. THEREFORE, BASED ON THE INFORMATION PROVIDED ONLY IT WOULD BE INAPPROPRIATE TO SPECULATE AT WHAT MAY OR MAY NOT HAVE CAUSED THE DIFFICULTIES IN CATCHING THE FILTER HOOK AND CONSEQUENTLY IN RETRIEVING THE FILTER. REPORTEDLY, THE FILTER HOOK WAS NOT CIRCLING PROPERLY THUS SUGGESTING THAT IT HAD BEEN SOMEHOW DAMAGED DURING ATTEMPTS TO CAPTURE IT WITH THE NON-COOK RETRIEVAL DEVICE, BUT THIS IS PURE SPECULATION AS NO IMAGING COULD BE OBTAINED. 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 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. ACCORDING TO THE INSTRUCTIONS FOR USE SUPPLIED WITH THE FILTER, IT IS DESIGNED TO BE RETRIEVED WITH THE GTRS RETRIEVAL SET. IT MAY ALSO BE RETRIEVED WITH THE CLOVERSNARE. COOK HAS NOT PERFORMED TESTING TO EVALUATE THE SAFETY OR EFFECTIVENESS OF FILTER RETRIEVAL USING OTHER RETRIEVAL SYSTEMS OR TECHNIQUES. THERE ARE ADEQUATE CONTROLS IN PLACE TO ENSURE THE DEVICE WAS MANUFACTURED TO SPECIFICATIONS. IT IS ASSESSED THAT BECAUSE NO NON-CONFORMANCE'S WERE DETECTED THERE IS EVIDENCE THAT THE DEVICE WAS MANUFACTURED IN COMPLIANCE WITH PROCEDURES AND ACCORDING TO SPECIFICATIONS. IN ADDITION, NO OTHER LOT RELATED COMPLAINTS HAVE BEEN RECEIVED FROM THE FIELD. IT IS THEREFORE CONCLUDED THAT THERE IS NO EVIDENCE THAT NON-CONFORMING PRODUCT EXISTS IN HOUSE OR IN FIELD. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. 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

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: ON (B)(6) 2024, A VASCULAR ONCOLOGY INTERVENTIONALIST PERFORMED A SCHEDULED INFERIOR VENA CAVA FILTER RETRIEVAL FOR A PATIENT WITH LOWER EXTREMITY VENOUS THROMBOSIS WHO HAD AN INFERIOR VENA CAVA FILTER PLACED. INTRAOPERATIVE USE OF THE FILTER RETRIEVER AND GRAPPLE FAILED TO RETRIEVE THE FILTER. ATTEMPTS AT VARIOUS METHODS FAILED TO CAPTURE THE FILTER HOOK. THE SURGEON THOUGHT THERE WAS A POTENTIAL FOR FILTER MIGRATION AND FILTER FILAMENT OCCLUSION, WHICH COULD RESULT IN VASCULAR OCCLUSION. THE FILTER HOOK'S NOT CIRCLING PROPERLY, THERE MAY BE A PROBLEM WITH THE HOOK. THE FILTER HAS NOT REMOVED OUT AND COULD NOT BE RETURNED BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1084167 COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE G35581 E4559821 10827002355818

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Life Threatening