BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET

    MDR report key: 19740935 · Received July 15, 2024

    Report

    Report Number
    3002808486-2024-00129
    Event Type
    Injury
    Date Received
    July 15, 2024
    Date of Event
    May 8, 2024
    Report Date
    August 19, 2024
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    UDI-DI
    10827002345048
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF# (B)(4). BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. G4) SIMILAR TO DEVICE UNDER PMA/510(K) K233680. 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: THE CELECT-PT FILTER DID NOT EXPAND AFTER FEMORAL DEPLOYMENT (B)(4). ATTEMPT TO ADJUST FILTER POSITION WITH GTRS WAS UNSUCCESSFUL, AS THE FILTER HOOK COULD NOT BE CAPTURED (B)(4). A SECOND FILTER WAS SUCCESSFULLY PLACED WITHOUT REMOVING THE FIRST ONE. NO INFORMATION AS TO PATIENT CONDITION OR FILTER RETRIEVAL COULD BE OBTAINED, BUT NO ADVERSE EFFECTS ON PATIENT WERE REPORTED. THE FIRST SCREEN SHOT DEMONSTRATES A VENOGRAM PERFORMED VIA A RIGHT COMMON FEMORAL APPROACH WITH THE IVC FILTER DEPLOYMENT SHEATH POSITIONED AT THE L3/L4 LEVEL AND FAINT OPACIFICATION OF WHAT IS PRESUMED TO BE THE IVC. THE IVC HAS A VERY SMALL DIAMETER MEASURING NO GREATER THAN 15 MM ON THIS IMAGE. IT ALSO HAS AN S-SHAPED CONFIGURATION AS IT EXTENDS CRANIALLY. THE INFLOW OF THE RENAL VEINS IS NOT CLEARLY APPRECIATED ON THIS IMAGE. THERE IS WHAT APPEARS BE A SMALL AMOUNT OF CONTRAST WITHIN THE RIGHT RENAL COLLECTING SYSTEM AND THE BLADDER. THE NEXT IMAGE DEMONSTRATES THE CELECT IVC FILTER DEPLOYED FROM THE DEPLOYMENT SYSTEM. THIS FILTER PROJECTS OVER THE RIGHT LATERAL ASPECT OF THE L3 VERTEBRAL BODY IN A COMPLETELY PARALLEL FASHION TO THE POSTERIOR SPINOUS PROCESSES WITHOUT ANY TILT. THE PRIMARY LEGS AND SECONDARY ARMS ARE CLUSTERED TOGETHER INTO A PINPOINT CONFIGURATION CAUDALLY AND ARE NOT EXPANDED. THE LAST IMAGE DEMONSTRATES AN ADDITIONAL CELECT PT IVC FILTER DEPLOYED JUST CAUDAL TO THE FIRST FILTER, SUCH THAT THE HOOK PROJECTS OVER THE PRIMARY FILTER FEET OF THE FIRST FILTER IN THIS PROJECTION. THE HOOK TERMINATES AT THE L3/L4 VERTEBRAL BODY DISC LEVEL. THIS FILTER HAS A SLIGHT RIGHTWARD TILT RELATIVE TO THE POSTERIOR SPINOUS PROCESSES MIRRORING THE INITIAL ANGULATION OF THE IVC SEEN ON THE INITIAL VENOGRAM. THE PRIMARY AND SECONDARY ARMS ARE SPREAD APART APPROPRIATELY. THE FIRST CELECT PT IVC FILTER THAT WAS DEPLOYED VIA FEMORAL APPROACH, WAS LIKELY DEPLOYED IN AN EXTRAVASCULAR LOCATION. GIVEN THE SMALL AND TORTUOUS IVC, IN ALL LIKELIHOOD, THE DEPLOYING PHYSICIAN ADVANCED THE FILTER OUTSIDE OF THE DEPLOYMENT SHEATH, INSTEAD OF UNSHEATHING THE IVC FILTER. THIS RESULTED IN THE FILTER PERFORATING THE WALL OF THE IVC AND EXTENDING ADJACENT TO THE IVC INSTEAD OF WITHIN THE IVC FILTER LUMEN. THIS WOULD RESULT IN THE IVC FILTER NOT EXPANDING AFTER IT HAD BEEN RELEASED FROM THE IVC FILTER DEPLOYMENT SYSTEM, AS WELL AS INABILITY TO CAPTURE THE FILTER VIA A JUGULAR APPROACH USING A FILTER RETRIEVAL SET, AS THE HOOK IS NOT WITHIN THE IVC LUMEN. IN ADDITION, THE INITIAL IMAGE OF THE DEPLOYED IVC FILTER SHOWS THAT IT PARALLELS THE POSTERIOR SPINOUS PROCESSES WITH 0 DEGREES OF TILT WHILE THE INITIAL VENOGRAM DEMONSTRATES TORTUOSITY OF THE IVC AT THIS LEVEL, SO THE FILTER SHOULD TECHNICALLY HAVE A RIGHTWARD TILT RELATIVE TO THE POSTERIOR SPINOUS PROCESSES, WHICH IT DOES NOT. CROSS-SECTIONAL IMAGING WOULD CONFIRM THIS SUSPICION. IF THIS FILTER IS NOT EXTRAVASCULAR, THEN THIS FILTER NEEDS TO BE REMOVED IN ORDER TO PREVENT MIGRATION. A SECOND CELECT PT IVC FILTER WAS DEPLOYED BELOW THE FIRST IVC FILTER AND THIS FILTERS FEET EXPANDED NORMALLY AND IS LIKELY WITHIN THE VESSEL SEEN ON THE INITIAL VENOGRAM, WHICH IS PRESUMED TO BE THE IVC. THERE ARE ADEQUATE CONTROLS IN PLACE TO ENSURE THAT THE DEVICE IS MANUFACTURED TO SPECIFICATIONS. IT IS ASSESSED THAT BECAUSE NO NON-CONFORMANCE'S WERE DETECTED THERE IS EVIDENCE THAT THE DEVICE WAS MANUFACTURED IN COMPLIANCE WITH PROCEDURES AND ACCORDING TO SPECIFICATIONS. IN ADDITION, NO OTHER LOT RELATED COMPLAINTS HAVE BEEN RECEIVED FROM THE FIELD. IT IS THEREFORE CONCLUDED THAT THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN FIELD. 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

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: DEPLOYMENT WAS PERFORMED AS USUAL, BUT THE CELECT FILTER DID NOT UNFOLD. PHYSICIAN TRIED TO ADJUST THE POSITION AGAIN USING RETRIEVAL SET, BUT IT IT WAS NOT RECAPTURED. PHYSICIAN HAD NO CHOICE BUT TO USE A NEW FILTER PRODUCT FOR IVC. PATIENT OUTCOME: THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    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
    209133 COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE G34504 E4179207 10827002345048

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention