BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK CELECT® PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET

    MDR report key: 17771420 · Received September 19, 2023

    Report

    Report Number
    3002808486-2023-00237
    Event Type
    Malfunction
    Date Received
    September 19, 2023
    Date of Event
    August 25, 2023
    Report Date
    November 13, 2023
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF# (B)(4). 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.

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF# (B)(4). BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. G4) DEVICE IS REGISTERED UNDER 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.

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF# (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: A CELECT PLATINUM FILTER WAS DEPLOYED VIA A JUGULAR APPROACH AND THE DEVICE WAS ROTATED CAUSING THE LEGS TO CROSS AND NOT EXPAND COMPLETELY. THE FILTER WAS RETRIEVED AND ANOTHER FILTER WAS SUCCESSFULLY PLACED WITH NO REPORTED HARM TO THE PATIENT. THE DEVICE WAS NOT RETURNED, BUT MULTIPLE IMAGES FROM TIME OF FILTER PLACEMENT WERE PROVIDED. VENOGRAM DEMONSTRATED THE FILTER DEPLOYED JUST CAUDAL TO THE RENAL VEINS. THERE IS 17 DEGREES OF LEFTWARD TILT. THE SECONDARY LEGS ARE NORMALLY EXPANDED. THE PRIMARY LEGS ARE CLUSTERED/ENTWINED PREVENTING THEIR APPROPRIATE EXPANSION AND WITH THE LEGS CLUSTERED TOGETHER, THE FILTER COULD NOT CENTER WITH EITHER THE SECONDARY OR PRIMARY LEGS CONTRIBUTING TO THE SIGNIFICANT TILT. THE DEPLOYING PHYSICIAN ROTATED THE DEVICE, PRESUMABLY IN THE DEPLOYMENT SHEATH, WHICH LIKELY RESULTED IN THIS CONFIGURATION, BUT THE IFU STATES NOT TO ROTATE THE PRELOADED FILTER INSIDE THE INTRODUCER SYSTEM. THE FILTER WAS RELEASED IN THIS CONFIGURATION, DESPITE THE APPEARANCE OF THE PRIMARY FILTER LEGS AND THE TILT. THE ADVANTAGE OF USING A JUGULAR APPROACH IS THE ABILITY TO RECAPTURE AND REPOSITION THE DEVICE APPROPRIATELY. WHY THE FILTER WAS RELEASED IN THIS CONFIGURATION IS UNCLEAR. MULTIPLE FLUOROSCOPIC IMAGES PRESUMABLE FROM TIME OF FILTER RETRIEVAL AND REPLACEMENT INITIALLY DEMONSTRATES A WIRE TRAVERSING THE IVC FILTER. THE PRIMARY LEGS APPEAR MORE WELL DISTRIBUTED THROUGH THE IVC AND THE LEFTWARD TILT NOW ONLY MEASURES 5 DEGREES. PRESUMABLY THIS ORIGINAL FILTER WAS REMOVED AS THERE WAS A SINGLE IMAGE DEMONSTRATING A LOOP SNARE IN PLACE AND A FINAL IMAGE DEMONSTRATES A CELECT PLATINUM IVC FILTER NOW WITH 14 DEGREES RIGHTWARD TILT AND 24MM MAXIMAL DISTANCE BETWEEN THE PRIMARY FILTER FEET. THERE ARE ADEQUATE CONTROLS IN PLACE TO ENSURE THAT THIS TYPE OF DEVICE IS 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.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 27SEP2023: PHYSICIAN ROTATED THE DEVICE TO ALIGN HOOK AND CAUSED LEGS TO CROSS. FILTER TILTED TOWARD THE LEFT RENAL AND LEGS CROSSED. THE FILTER WAS RETRIEVED AND A SECOND ONE WAS PLACED SUCCESSFULLY.

    Description of Event or Problem · 0

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: FILTER WAS PUT IN THROUGH THE JUGULAR, AND AT LEAST TWO OF THE LEGS CROSSED. POSSIBLE RETRIEVAL SCHEDULED FOR MONDAY.

    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
    137793 COOK CELECT® PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention