BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 18745659 · Received February 21, 2024

    Report

    Report Number
    3002808486-2024-00035
    Event Type
    Injury
    Date Received
    February 21, 2024
    Date of Event
    February 7, 2024
    Report Date
    March 13, 2024
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF#: (B)(4). H11) CORRECTED DATA COMPARED WITH MEDWATCH REPORT: 5151583. D1) CELECT INFERIOR VENA CAVA FILTER. D3) COOK MEDICAL LLC. E1) (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: FRACTURED COOK CELECT INFERIOR VENA CAVA FILTER. REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE. THE FRACTURED CELECT FILTER WAS NOT RETURNED AND BASED ON THE INFORMATION PROVIDED IT WOULD BE INAPPROPRIATE TO SPECULATE AT WHAT MAY OR MAY NOT HAVE CAUSED THE FILTER TO FRACTURE DURING AN IMPLANT PERIOD OF MORE THAN TEN YEARS. FILTER FRACTURE HAS BEEN REPORTED AND MAY BE EITHER SYMPTOMATIC OR ASYMPTOMATIC. FRACTURE OF A FILTER LEG MAY BE DUE TO REPETITIVE MOTION ON A FILTER LEG IN AN UNUSUAL, STRESSED POSITION, SUCH AS A FILTER LEG PENETRATING/PERFORATING THE IVC; OR A FILTER LEG BEING CAUGHT IN A SIDE BRANCH (E.G., A RENAL VEIN). OTHER POTENTIAL CAUSES OF FILTER FRACTURE MAY INCLUDE EXCESSIVE FORCE OR MANIPULATIONS NEAR AN IMPLANTED FILTER (E.G., A SURGICAL OR ENDOVASCULAR PROCEDURE IN THE VICINITY OF A FILTER). RETRIEVAL OF A FRACTURED FILTER OR FILTER FRAGMENTS (INCLUDING EMBOLIZED FRAGMENTS) USING ENDOVASCULAR TECHNIQUES HAS BEEN REPORTED. POTENTIAL ADVERSE EVENTS THAT MAY OCCUR INCLUDE, BUT ARE NOT LIMITED TO, THE FOLLOWING: FILTER FRACTURE, FILTER OR FILTER FRAGMENT EMBOLIZATION, TRAUMA TO ADJACENT STRUCTURES. THERE ARE ADEQUATE CONTROLS IN PLACE TO ENSURE THAT THE TYPE OF DEVICE WAS MANUFACTURED TO SPECIFICATIONS. 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 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.

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF# (B)(4). BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. G4) PMA/510(K): K211875. INVESTIGATION IS STILL IN PROGRESS. 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

    MEDWATCH: 5151583 RECEIVED 07MAR2024.

    Description of Event or Problem · 0

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: FRACTURED COOK CELECT INFERIOR VENA CAVA FILTER. REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1298145 UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Required Intervention