BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK CELECT® PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET

    MDR report key: 14049491 · Received April 8, 2022

    Report

    Report Number
    3002808486-2022-00224
    Event Type
    Malfunction
    Date Received
    April 8, 2022
    Report Date
    April 6, 2022
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    UDI-DI
    10827002343099
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF# (B)(4). PMA/510(K): K171712. SUMMARY OF INVESTIGATIONAL FINDINGS: IT WAS REPORTED THAT THE FILTER WAS DEPLOYED INTO THE RIGHT COMMON ILIAC VEIN. THE PHYSICIAN DECIDED TO USE A SNARE TO REPOSITION THE FILTER. AFTER THE FILTER WAS REPOSITIONED, THE FILTER WAS APPROPRIATELY POSITIONED BELOW THE LOWEST RENAL VEIN. IT WAS ASSESSED THAT BECAUSE NO NON-CONFORMANCE'S WERE DETECTED, THERE IS EVIDENCE THAT THE DHR WAS FULLY EXECUTED. IT IS THEREFORE CONCLUDED THAT THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN FIELD. ACCORDING TO THE INSTRUCTION FOR USE FILTER MALPOSITIONING IS A KNOWN ADVERSE EVENT. THERE ARE ADEQUATE CONTROLS IN PLACE TO ENSURE THE DEVICE WAS MANUFACTURED TO SPECIFICATIONS. NO PRODUCT OR IMAGES WERE PROVIDED FOR THE INVESTIGATION AND WITHOUT IMAGES OR PRODUCT IT WOULD BE INAPPROPRIATE TO SPECULATE WHAT MAY OR MAY NOT HAVE CAUSED THE FILTER TO BE DEPLOYED IN RIGHT COMMON ILIAC VEIN. HOWEVER, FILTER MALPOSITIONING IS A KNOWN ADVERSE EVENT.

    Description of Event or Problem · 0

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: UNDER DIRECT FLUOROSCOPIC GUIDANCE, THE FILTER WAS POSITIONED AND DEPLOYED. A HAND INJECTION WAS PERFORMED TO ASSESS FILTER POSITION. THIS INJECTION SHOWED THE FILTER HAVE BEEN DEPLOYED INTO THE RIGHT COMMON ILIAC VEIN. THE FILTER DELIVERY SHEATH WAS EXCHANGED AT THE NECK FOR A LONG 8 FRENCH SHEATH. A 6 FRENCH 12-20 MM AND SNARE DEVICE WAS ADVANCED OVER WIRE AND POSITIONED ABOVE THE IVC FILTER HOOK. THE HOOK WAS ENGAGED. WITH TRACTION, THE HOOK WAS REPOSITIONED SLIGHTLY MORE CEPHALAD. REPEAT INJECTION SHOWED THE FILTER WAS STILL NOT PROVIDING ADEQUATE FILTRATION FOR THE LEFT SIDE IN THIS PATIENT WITH LEFT LOWER EXTREMITY DVT. THE SNARE WAS USED TO REENGAGE THE FILTER HOOK, AND THE FILTER REPOSITIONED WITH ITS HOOK AT THE L3 SUPERIOR ENDPLATE. CONTRAST INJECTION SHOWED APPROPRIATE LOCATION - BELOW THE LOWEST RENAL VEIN. PATIENT OUTCOME: NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1967515 COOK CELECT® PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE G34309 E3697861 10827002343099

    Patients

    Seq Age Sex Outcome Treatment
    1 Female