BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET

    MDR report key: 20531196 · Received October 25, 2024

    Report

    Report Number
    3002808486-2024-00227
    Event Type
    Injury
    Date Received
    October 25, 2024
    Date of Event
    July 30, 2024
    Report Date
    October 25, 2024
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    UDI-DI
    10827002345048
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURERS REF:(B)(4). BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. G4) SIMILAR TO DEVICE MARKETED UNDER PMA/510(K): K233680 AFTER INVESTIGATION COMPLETED 03OCT2024, THE EVENT IS CONSIDERED REPORTABLE. SUMMARY OF INVESTIGATIONAL FINDINGS: THE FILTER DETACHED FROM THE JUGULAR INTRODUCER WITHOUT PRESSING THE RELEASE BUTTON. THE FILTER WAS REPOSITIONED BY USING OTHER DEVICES. NO REPORTED HARM TO THE PATIENT. THE DEVICE WAS NOT RETURNED FOR ANALYSIS, BUT A SINGLE POOR-QUALITY FLUOROSCOPIC VIDEO AT TIME OF IVC FILTER PLACEMENT WAS SUBMITTED FOR REVIEW. THIS SHOWS A CELECT-PT FILTER IN THE JUGULAR DEPLOYMENT ARRANGEMENT IN THE SUPERIOR VENA CAVA (SVC) FROM A FEMORAL APPROACH. THERE IS AN ADDITIONAL SHEATH IN THE SVC ADVANCED FROM THE FEMORAL APPROACH. THE VIDEO BEGINS WITH THE IVC FILTER PARTIALLY DEPLOYED, BUT STILL ATTACHED TO THE DEPLOYMENT SYSTEM. THE DEPLOYMENT SHEATH IS BEING SLOWLY ADVANCED OVER THE IVC FILTER RESULTING IN THE COLLAPSE OF THE IVC FILTER. ONCE THE SHEATH GETS TO THE FILTER FEET, THE HOOKS OF THE FILTER FEET DO NOT COMPLETELY RETRACT INTO THE SHEATH, BUT RATHER APPEAR TO GET STUCK ON THE EDGE OF THE SHEATH. THE OPERATOR APPEARS TO CONTINUE TO PULL ON THE DEPLOYMENT SYSTEM ATTEMPTING TO GET THE FILTER FEET ENTIRELY WITHIN THE DEPLOYMENT SHEATH. DURING THIS MANEUVER THE GRASPING HOOK BECOMES DETACHED FROM THE RETRIEVAL HOOK OF THE IVC FILTER WITH THE FILTER MOSTLY CONTAINED WITHIN THE DEPLOYMENT SHEATH. 1. THE CELECT PT WAS BEING DEPLOYED IN THE SVC, WHICH IS NOT INCLUDED IN THE APPROVED PLACES FOR DEPLOYMENT IN THE IFU. 2. THERE ARE NO IMAGES DEMONSTRATING THE SIZE OF THE SVC TO DETERMINE IF THERE WERE OTHER ISSUES AT PLAY SUCH AS A STENOSIS, OR THROMBUS IN THE SVC POTENTIALLY CONTRIBUTING TO FILTER FEET NOT COMPLETELY COLLAPSING INTO THE DEPLOYMENT SHEATH. 3. THE GRASPING HOOK IS ONLY DESIGNED TO WITHSTAND A CERTAIN AMOUNT OF FORCE WHILE ATTEMPTING TO COLLAPSE THE IVC FILTER. IF THE HOOKS OF THE IVC FILTER FEET WERE STRONGLY ENGAGED WITH THE WALL OF THE SVC, AGAIN, POTENTIALLY DUE TO SIZE OR THROMBUS, THE FORCE REQUIRED TO FREE THEM COMPLETELY MAY HAVE BEEN GREATER THAN THE FORCES ENGAGING THE GRASPING HOOK WITH THE RETRIEVAL HOOK RESULTING IN THIS SCENARIO. 4. IF DURING THE COLLAPSE OF THE IVC FILTER, THE FILTER FEET BECOME ROTATED SO THE ANCHORING PORTIONS OF THE HOOK INADVERTENTLY ENGAGED WITH THE DEPLOYMENT SHEATH LIP, THIS COULD HAVE RESULTED IN THE DESCRIBED SCENARIO. 5. WITHOUT ADDITIONAL INFORMATION, DETERMINING THE UNDERLYING CAUSE OF THE FILTER NOT COMPLETELY RETRACTING INTO THE SHEATH WOULD MOSTLY BE SPECULATION. FORTUNATELY, THE OPERATOR WAS ABLE TO USE ADDITIONAL DEVICES TO CORRECT THE FILTERS POSITION. THERE ARE ADEQUATE CONTROLS IN PLACE TO ENSURE THE DEVICE WAS 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 NON-CONFORMING PRODUCT EXISTS IN HOUSE OR IN FIELD. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. 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.

    Description of Event or Problem · 0

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE PHYSICIAN MOVED FILTER FROM FEM DEVICE TO JUG DEVICE AND CONFIRMED IT WAS COMPLETELY INSTALLED, BUT THE FILTER WAS DETACHED WITHOUT PRESSING THE RELEASE BUTTON. THE POSITION WAS NOT SATISFACTORILY AT FIRST, THEN THE PHYSICIAN REPOSITIONED IT BY USING OTHER DEVICES (SHEATH, CATHETER AND WIRE) TO MAKE IT TO A BETTER POSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1121840 COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE G34504 E4525887 10827002345048

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other