BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET

    MDR report key: 14021296 · Received April 6, 2022

    Report

    Report Number
    3002808486-2022-00223
    Event Type
    Malfunction
    Date Received
    April 6, 2022
    Report Date
    April 28, 2022
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    UDI-DI
    10827002345055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF# (B)(4). INITIAL MDR WAS SUBMITTED BY COOK INC UNDER MANUFACTURER REPORT REFERENCE# 1820334-2022-00404. ADDITIONAL INFORMATION PROVIDED DETERMINED THAT THIS DEVICE WAS MANUFACTURED BY WILLIAM COOK EUROPE. WITH THE SUBMISSION OF THIS INITIAL REPORT, WILLIAM COOK EUROPE INFORMS THAT ALL FUTURE SUBMISSIONS REGARDING THIS COMPLAINT WILL BE HANDLED BY WILLIAM COOK EUROPE. OCCUPATION: UNKNOWN, BUT REFERRED TO AS A HEALTH CARE PROFESSIONAL. PMA/510(K): K211875.

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF# (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: IT WAS REPORTED THAT TO RETRIEVE A CELECT-PT FILTER IT WAS NECESSARY TO USE NON-STANDARD TECHNIQUES AND EXTRA DEVICES. IT WAS ASSESSED THAT BECAUSE ANY DISCOVERED NON-CONFORMANCES WERE PROPERLY DISPOSITIONED BEFORE QC RELEASE, THERE IS EVIDENCE THAT THE DHR WAS FULLY EXECUTED. IN ADDITION, NO OTHER LOT RELATED COMPLAINTS HAVE BEEN RECEIVED FROM THE FIELD. IT IS THEREFORE CONCLUDED THAT THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN FIELD. THERE ARE ADEQUATE CONTROLS IN PLACE TO ENSURE THE DEVICE WAS MANUFACTURED TO SPECIFICATIONS. NO DEVICE OR IMAGES WERE PROVIDED FOR THE INVESTIGATION AND WITHOUT THE ACTUAL DEVICE OR IMAGES IT WOULD BE INAPPROPRIATE TO SPECULATE WHAT MAY OR MAY NOT HAVE CAUSED THE RETRIEVAL DIFFICULTY. 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). FOR ALL RETRIEVABLE IVC FILTERS, RETRIEVAL BECOMES MORE CHALLENGING WITH TIME, AND THIS IS COMMONLY DUE TO ENCAPSULATION OF THE FILTER LEGS OR HOOK (IN A TILTED FILTER) BY TISSUE INGROWTH. 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. SPECIFIC FOR ¿EMBEDDED¿ A FILTER THAT IS EMBEDDED IN THE WALL OF THE IVC MAY BE DIFFICULT TO RETRIEVE. FOR ALL RETRIEVABLE IVC FILTERS, RETRIEVAL BECOMES MORE CHALLENGING WITH TIME, AND THIS IS COMMONLY DUE TO ENCAPSULATION OF THE FILTER LEGS OR HOOK (IN A TILTED FILTER) BY TISSUE INGROWTH. 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: WE HAVE HAD A FEW ISSUES WITH RETRIEVAL. REGARDING THE COOK CELECT PLATINUM VENA CAVA FILTER SET WE HAVE NOTED ISSUES UPON THE RETRIEVAL PROCESS OF THIS PARTICULAR DEVICE. WE HAVE NEEDED TO USE NON-STANDARD TECHNIQUES AND EXTRA DEVICES IN ORDER SUCCESSFULLY RETRIEVE AND SUBSEQUENTLY REMOVE THESE FILTERS. PATIENT OUTCOME: UNKNOWN.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1441569 COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE G34505 E4029476 10827002345055

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown