BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK CELECT® PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET

    MDR report key: 14444264 · Received May 19, 2022

    Report

    Report Number
    3002808486-2022-00612
    Event Type
    Injury
    Date Received
    May 19, 2022
    Report Date
    May 18, 2022
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    UDI-DI
    10827002345024
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER (PERSON) NOT PROVIDED, INFORMATION PROVIDED BY DALIMONTE RUEB STOLLER LLP. OCCUPATION: NON-HEALTHCARE PROFESSIONAL. 510(K) #: K211875. INVESTIGATION: 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 GUNTHER 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. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 0

    IT IS ALLEGED THAT "PATIENT RECEIVED A COOK CELECT PLATINUM FILTER. PATIENT IS ALLEGING IRRETREVABLE FILTER. HOSPITAL AND MEDICAL RECORDS HAVE NOT BEEN PROVIDED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2268232 COOK CELECT® PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE G34502 E3411075 10827002345024

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Life Threatening