BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK CELECT PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET

    MDR report key: 23742049 · Received December 8, 2025

    Report

    Report Number
    3002808486-2025-00253
    Event Type
    Injury
    Date Received
    December 8, 2025
    Date of Event
    July 18, 2025
    Report Date
    December 8, 2025
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    UDI-DI
    10827002345048
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF# (B)(4). AFTER INVESTIGATION ON 01DEC2025 THE EVENT IS CONSIDERED REPORTABLE TO FDA. G4) SIMILAR TO DEVICE MARKETED UNDER 510(K)/PMA: K233680. SUMMARY OF INVESTIGATIONAL FINDINGS: AFTER DIFFICULT FEMORAL ACCESS THE CELECT-PT FILTER TILTED DURING PLACEMENT. SIGNIFICANT TILT NOTED PRE-DEPLOYMENT COULD NOT BE CORRECTED ¿DESPITE RESHEATHING¿. THE FILTER REMAINED IN ASYMPTOMATIC PATIENT. THE COMPLAINT REPORTED BY THE USER WAS CONFIRMED. THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR SALES REPRESENTATIVE TESTIMONY. THE DEVICE EVALUATION COULD NOT BE PERFORMED AS THE DEVICE OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE MANUFACTURING RECORDS AND/OR SPECIFICATIONS DID NOT REVEAL ANY DISCREPANCIES/NONCONFORMANCES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. THE INVESTIGATION CONCLUDES THE COMPLAINT DEVICE WAS MANUFACTURED TO SPECIFICATION. THE REVIEW OF THE RELEVANT MANUFACTURING RECORDS CONFIRMS THE FAILURE HAS NOT PREVIOUSLY OCCURRED FOR THIS MANUFACTURING LOT. THERE IS NO EVIDENCE TO SUGGEST THAT THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE AND/OR LABEL. A DEFINITIVE CAUSE COULD NOT BE DETERMINED FROM THE INVESTIGATION. POSSIBLE CAUSES ARE ADVANCEMENT DURING FILTER RELEASE OR MANIPULATION DURING ATTEMPT TO RE-SHEATH. AN INTERNAL ACTION IS NOT DEEMED NECESSARY AT THIS TIME. TRENDING WILL MONITOR IF ANY FUTURE ACTIONS ARE REQUIRED. AFTER CONSIDERING THIS EVENT THE RISK ASSOCIATED WITH THE USE OF THIS DEVICE IS STILL DEEMED ADEQUATE. 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 STUDY ((B)(6): POST-MARKET COOK VENA CAVA FILTERS AND GÜNTHER TULIP RETRIEVAL SET): ON THE DAY OF THE PROCEDURE, X-RAY IMAGING IDENTIFIED FILTER TILT 16 DEGREES. ON (B)(6) 2025, THIS 52-YEAR-OLD FEMALE PATIENT RECEIVED THE STUDY DEVICE FOR TEMPORARY USE IN THE PERIOPERATIVE SETTING IN A PATIENT WITH HISTORY OF PE/DVT FOR WHOM ANTICOAGULATION MUST BE INTERRUPTED. A DEVICE DEFICIENCY (FILTER TILT) WAS NOTED DURING THE STUDY PROCEDURE. THE SITE COMMENTED, ¿FILTER PLACED AT A TILT OF AROUND 17DEGREES. SIGNIFICANT TILT NOTED PRE DEPLOYMENT THAT THEY WERE NOT ABLE TO CORRECT DESPITE RESHEATHING AND GOING MORE CRANIAL. DIFFICULT FEMORAL ACCESS DUE TO PATIENT HAVING LARGE LOWER ABDOMINAL APRON AND BEING UNABLE TO LIE COMPLETELY FLAT.¿ PATIENT OUTCOME: PATIENT WAS ASYMPTOMATIC. THE FILTER REMAINS IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2437206 COOK CELECT PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE G34504 E4534203 10827002345048

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female