BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 20840671 · Received December 4, 2024

    Report

    Report Number
    3002808486-2024-00254
    Event Type
    Injury
    Date Received
    December 4, 2024
    Date of Event
    September 24, 2024
    Report Date
    January 23, 2025
    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

    MANUFACTURERS REF# (B)(4). D4) CATALOG# IS UNKNOWN BUT REFERRED TO AS COOK CELECT PLATINUM FILTER. G5) PMA/510(K) K233680. INVESTIGATION IS STILL IN PROGRESS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21CFR 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

    MANUFACTURER REF# (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: DURING A 1-YEAR DWELL TIME A CELECT-PT FILTER WAS FRACTURED AND A FILTER LEG HAD MIGRATED TO RIGHT VENTRICLE. THE FILTER WAS SUCCESSFULLY REMOVED AND TWO MONTHS LATER THE FRACTURED LEG WAS REMOVED. THE FILTER WAS NOT RETURNED FOR ANALYSIS AND NO IMAGING COULD BE OBTAINED. THEREFORE, BASED ON THE INFORMATION PROVIDED IT WOULD BE INAPPROPRIATE TO SPECULATE AT WHAT MAY OR MAY NOT HAVE CAUSED THE FILTER FRACTURE. 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. 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

    MANUFACTURER REF# (B)(4). H11) CORRECTED DATA COMPARED WITH MEDWATCH REPORT MW5162967. B4) 21NOV2024. H6) E CODE: 2687: FOREIGN BODY IN PATIENT. 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

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: A 73-YEAR-OLD MALE PATIENT UNDERWENT AN UNSPECIFIED PROCEDURE ON (B)(6) 2023 IN WHICH A CELECT VENA CAVA FILTER WAS IMPLANTED. DATE OF EVENT: 24SEP 2024. CELECT PLATINUM INFERIOR VENA CAVA FILTER FRACTURED WITH ONE ARM MIGRATED TO RIGHT VENTRICLE. PATIENT OUTCOME: FILTER REMOVED AND REFERRED TO THE PHYSICIAN. RIGHT VENTRICLE FRAGMENT REMOVED (B)(6) 2024 PERCUTANEOUSLY.

    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.

    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
    1849910 UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention