BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK CELECT® PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET

    MDR report key: 14018692 · Received April 6, 2022

    Report

    Report Number
    3002808486-2022-00222
    Event Type
    Injury
    Date Received
    April 6, 2022
    Date of Event
    March 14, 2022
    Report Date
    April 21, 2022
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF# (B)(4). PMA/510(K): K211875. INVESTIGATION IS STILL IN PROGRESS.

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF# (B)(4). ADDITIONAL INFORMATION DETERMINATES THAT THE FILTER WAS NOT THE CAUSE OF THE THIS EVENT, AND THAT THIS COMPLAINT IS NO LONGER REPORTABLE. 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: A FEMORAL IVC FILTER WAS PLACED IN A PATIENT VIA THE RIGHT GROIN ON (B)(6) 2022. ON (B)(6) 2022, THE PATIENT CALLED US COMPLAINING OF PAIN IN THE RIGHT LOWER QUADRANT RADIATING TO THEIR BACK. THE PATIENT WAS TO COME INTO THE OFFICE IN THE AFTERNOON, BUT CALLED BACK TO CANCEL AS THE PAIN WAS SO GREAT THAT THEY WENT TO ER INSTEAD. THE PATIENT HAD A CT AND THEY DISCOVERED A LARGE RETROPERITONEAL BLEED WHICH APPEARS TO HAVE ORIGINATED FROM ONE OF THE LEGS OF THE FILTER POKING THROUGH. THE PLACEMENT OF THE FILTER HAD BEEN DONE WITHOUT ANY SORT OF DIFFICULTY. PATIENT OUTCOME: ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 18APR2022: IT WAS DETERMINED THAT THE FILTER WAS NOT THE CAUSE OF THE RETOPERITONEAL BLEED SO ESSENTIALLY THIS COMPLAINT IS NO LONGER A COMPLAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1821454 COOK CELECT® PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening