BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET

    MDR report key: 20004599 · Received August 20, 2024

    Report

    Report Number
    3002808486-2024-00168
    Event Type
    Injury
    Date Received
    August 20, 2024
    Date of Event
    May 25, 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 Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF# (B)(4). G4) SIMILAR TO DEVICE MARKETED UNDER PMA/510(K) K233680 SUMMARY OF INVESTIGATIONAL FINDINGS: THE SELECT-PT FILTER DID NOT EXPAND PROPERLY. A SECOND FILTER WAS SUCCESSFULLY PLACED WITHOUT REMOVING THE FIRST ONE. PATIENT IS DOING BETTER. A JUGULAR INTRODUCER AND A COAXIAL INTRODUCER SYSTEM WERE RETURNED. NO BLOOD/BIOLOGICAL MATTER WAS OBSERVED ON ANY DEVICE AND THE JUGULAR INTRODUCER WORKED AS INTENDED. THE FIRST FLUOROSCOPIC IMAGES FROM TIME OF IVC FILTER PLACEMENT DEMONSTRATE A SELECT PT IVC FILTER DEPLOYED TO THE RIGHT OF THE POSTERIOR SPINOUS PROCESSES WITH HOOK TERMINATING AT THE SUPERIOR ENDPLATE OF THE LIKELY L2 VERTEBRAL BODY. THERE IS NO SIGNIFICANT TILT RELATIVE TO THE POSTERIOR SPINOUS PROCESSES. THE PRIMARY FILTER FEET ARE CLUSTERED TOGETHER WITH MAXIMAL DISTANCE BETWEEN THE FEET MEASURING 5 MM. THE SECONDARY ARMS DO NOT EXTEND FARTHER THAN THE PRIMARY FILTER LEGS. THE SECOND FLUOROSCOPIC IMAGE DEMONSTRATES THE FILTER DESCRIBED ABOVE IN NEARLY IDENTICAL CONFIGURATION. HOWEVER, THE MAXIMAL DISTANCE BETWEEN THE PRIMARY FILTER FEET MEASURES 6.8MM, WHERE ON THE FIRST IMAGE THIS DISTANCE MEASURED 5MM. THERE HAS BEEN PLACEMENT OF AN ADDITIONAL CELECT PT IVC FILTER JUST TO THE LEFT AND SLIGHTLY MORE CRANIAL COMPARED WITH THE ORIGINAL FILTER PLACEMENT. THIS FILTER HAS A MORE NORMAL CONFIGURATION WITHOUT EVIDENCE OF SIGNIFICANT TILT AND THE MAXIMUM DISTANCE BETWEEN THE PRIMARY FILTER FEET NOW MEASURING 16MM. THE DEPLOYMENT SHEATH TIP IS LOCATED JUST CAUDAL TO THE FILTER FEET, INDICATING A FEMORAL DEPLOYMENT. AS IS EVIDENT ON BOTH IMAGES SUBMITTED FOR REVIEW THE CELECT PT IVC FILTER DOES NOT APPEAR TO BE IN A NORMAL CONFIGURATION, IF THE FILTER WAS DEPLOYED IN A NORMAL CALIBER IVC. THE PRE-PLACEMENT VENOGRAM WAS NOT SUBMITTED FOR REVIEW TO VERIFY THE IVC IS INDEED NORMAL AT THIS LEVEL. THERE ARE SEVERAL POTENTIAL EXPLANATIONS FOR THE APPEARANCE OF THE UNDER EXPANDED IVC FILTER, DEPENDING IF THE FIRST FILTER WAS DEPLOYED VIA A JUGULAR VS FEMORAL APPROACH. THE COMPLAINT REPORT SPECIFIES A UNI-CELECT FILTER WAS USED, SO EITHER IS POSSIBLE, ALTHOUGH AFTER THE SECOND FILTER WAS DEPLOYED, THE DEPLOYMENT SHEATH IS SEEN CAUDAL TO THE FILTER FEET, SUGGESTING AT LEAST THE SECOND FILTER WAS DEPLOYED FROM A FEMORAL APPROACH. IF THE FIRST FILTER WAS DEPLOYED VIA A JUGULAR APPROACH, IT MAY HAVE BEEN INADVERTENTLY DEPLOYED INTO THE GONADAL VEIN, WHICH IS MUCH SMALLER IN CALIBER AND WOULD ACCOUNT FOR THE LACK OF EXPANSION. IF THE FILTER WAS DEPLOYED VIA A FEMORAL APPROACH, IT MAY HAVE ALSO BEEN DEPLOYED IN A COLLATERAL/LUMBAR VEIN, OR EVEN PUSHED THROUGH THE WALL OF THE IVC IF IT ADVANCED OUT OF THE DEPLOYMENT SHEATH, RATHER THAN A PIN/PULL TECHNIQUE. IN ADDITION, IF IT WAS DEPLOYED FROM A JUGULAR APPROACH, WHY WAS IT RELEASED FROM THE DEPLOYMENT SYSTEM IF THE PRIMARY LEGS DID NOT EXPAND. THE SAME ARGUMENT COULD BE MADE FROM A FEMORAL APPROACH AS WELL, IF THE SECONDARY ARMS DID NOT EXPAND NORMALLY, WHY WAS THE FILTER RELEASED? IN ADDITION, IF THERE WAS THROMBUS IN THE IVC AND THIS ENCASED THE IVC FILTER DURING DEPLOYMENT, THIS COULD HAVE ALSO INHIBITED ITS INITIAL EXPANSION. AFTER DEPLOYMENT OF THE SECOND FILTER THE FIRST FILTER FEET APPEAR TO HAVE EXPANDED SLIGHTLY MORE THAN ORIGINALLY, SUGGESTING THAT IT MAY BE IN THE PROCESS OF CONTINUING TO EXPAND. IF THIS IS THE CASE, TYPICALLY MANIPULATING A WIRE OR SHEATH THROUGH THE PARTIALLY EXPANDED FILTER WILL USUALLY FACILITATE THE CONTINUED EXPANSION OF THE FILTER FEET. THE SECOND FILTER HAS A MORE NORMAL CONFIGURATION, BUT THEORETICALLY COULD ALLOW THE INITIALLY DEPLOYED FILTER TO PASS THROUGH THE FILTER, ALTHOUGH UNLIKELY. IMPORTANTLY, THE EXACT LOCATION AND THERE FOR RISK OF MIGRATION OF THE FIRST FILTER IS NOT WELL UNDERSTOOD FROM THESE LIMITED IMAGES. THE FIRST FILTER SHOULD BE FURTHER EVALUATED WITH CROSS SECTIONAL IMAGING AND RETRIEVAL SHOULD STRONGLY BE CONSIDERED. THERE ARE ADEQUATE CONTROLS IN PLACE TO ENSURE THAT THE DEVICE IS MANUFACTURED TO SPECIFICATIONS. IT IS ASSESSED THAT BECAUSE ANY DISCOVERED NON-CONFORMANCES WERE PROPERLY DISPOSITIONED BEFORE RELEASE, 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: SINCE THE FIRST ONE WAS NOT OPENED PROPERLY PHYSICIAN WAS FORCED TO USE THE SECOND ONE TO COMPLETE THE CASE ADDITIONAL INFORMATION RECEIVED 05JULY2024: PHYSICIAN DEPLOYED SECOND ONE WITH OUT REMOVING THE UN EXPANDED ONE AND PATIENT IS DOING BETTER. CURRENTLY THERE IS NO ANY PLAN RETRIEVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2398330 COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE G34504 E4516154 10827002345048

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other