BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK CELECT® PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET

    MDR report key: 14571817 · Received June 2, 2022

    Report

    Report Number
    3002808486-2022-00754
    Event Type
    Malfunction
    Date Received
    June 2, 2022
    Date of Event
    March 22, 2022
    Report Date
    June 2, 2022
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    UDI-DI
    10827002343099
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER REF#: (B)(4). OCCUPATION: (B)(6). PMA/510(K): K211875. SUMMARY OF INVESTIGATIONAL FINDINGS: THE FILTER ITSELF DID NOT OPEN UP. IT DID NOT EXPAND TO THE CAVA WALLS. THEY REMOVED IT AND SUCCESSFULLY COMPLETED THE PROCEDURE WITH ANOTHER DEVICE OF THE SAME TYPE. THE FILTER WAS RETURNED FOR DEVICE EVALUATION. BLOOD AND BIOLOGICAL MATTER WERE OBSERVED AT THE DEVICE. ONE PRIMARY LEG WAS NOT LEANING AT THE TABLE, NO OTHER NONCONFORMANCE OBSERVED. THE CAUSE FOR THE REPORTED FAILURE CANNOT BE DETERMINED, BASED ON THE DEVICE EVALUATION. A SINGLE FLUOROSCOPIC IMAGE WAS PROVIDED FOR IMAGING REVIEW. PER IMAGING REVIEWER´S FINDINGS: SINGLE FLUOROSCOPIC IMAGE DEMONSTRATES A CELECT PLATINUM IVC FILTER AT LEVEL OF L2. THE FILTER IS IN A COLLAPSED CONFIGURATION. ON THIS SINGLE IMAGE, IT APPEARS THE FILTER HAS BEEN DETACHED FROM THE DEPLOYMENT DEVICE. THERE IS A WIRE THAT COURSES PARALLEL TO THE FILTER AND HAS BEEN PRESUMABLY ADVANCED THROUGH THE DEPLOYMENT SHEATH AFTER THE FILTER HAD BEEN RELEASED FROM THE DEPLOYMENT SYSTEM. THE MAXIMAL DISTANCE BETWEEN THE PRIMARY FILTER FEET MEASURES LESS THAN 5MM, AND THE SECONDARY FILTER LEGS ARE ALSO COMPLETELY COLLAPSED. PER IMAGING REVIEWER´S IMPRESSIONS: PER THE COMPLAINT REPORT THE CELECT PLATINUM IVC FILTER WAS PLACED VIA A JUGULAR APPROACH. UPON DEPLOYMENT OF THE FILTER, THE PRIMARY AND SECONDARY LEGS OF THE FILTER DID NOT EXPAND APPROPRIATELY. ON THE SINGLE IMAGE SUBMITTED FOR REVIEW, THE FILTER IS COMPLETELY COLLAPSED AND NO LONGER APPEARS TO BE ATTACHED TO THE DELIVERY SYSTEM. THERE ARE SEVERAL POTENTIAL EXPLANATIONS FOR THE FILTER BEHAVING IN THIS MANNER. THE MOST LIKELY SCENARIO IS THAT THE FILTER WAS PARTIALLY DEPLOYED IN EITHER THE RIGHT GONADAL VEIN OR A COLLATERAL, AND NOT THE IVC. THIS MISTAKE CAN OCCUR IF FOLLOWING THE INFERIOR VENOCAVOGRAM THE WIRE ACCESS IS RETRACTED CRANIAL TO THE ORIGIN OF EITHER THE RIGHT GONADAL VEIN OR A COLLATERAL. THE PHYSICIAN THEN ADVANCES THE WIRE CAUDALLY, WHICH INADVERTENTLY SELECTS ONE OF THESE OTHER, SMALLER VEINS, NOT THE IVC. THE FILTER IS THEN DEPLOYED IN THIS SMALLER VEIN, AND CANNOT EXPAND, AS SEEN ON THIS SINGLE IMAGE. IF THE HOOK OF THE IVC FILTER STILL EXTENDS INTO THE IVC, THE OPERATOR CAN SNARE AND REMOVE THE FILTER, WITHOUT EVER REALIZING THE FILTER WAS DEPLOYED IN A NON-TARGET VEIN. OTHER POTENTIAL, LESS LIKELY EXPLANATIONS WOULD INCLUDE THROMBUS ENCASING THE IVC FILTER IF THE DEPLOYMENT SHEATH WAS NOT FLUSHED PRIOR TO ADVANCING THE FILTER THROUGH THE SHEATH. LASTLY, WOULD BE A DEVICE DEFECT. THE FILTER WAS RETRIEVED, BUT THERE IS NO COMMENT REGARDING IF THE FILTER OPENED NORMALLY ON THE BACK TABLE ONCE THE FILTER WAS RETRIEVED. IN ADDITION, IT APPEARS THE FILTER HAD BEEN DETACHED FROM THE DEPLOYMENT HOOK ON THIS IMAGE. THE OPERATOR SHOULD HAVE NEVER DETACHED THE FILTER FROM THE DEPLOYMENT SYSTEM IF THEY RECOGNIZED THE FILTER WAS NOT BEHAVING APPROPRIATELY. FORTUNATELY, THE FILTER WAS REMOVED AND REPLACED WITHOUT INJURY TO THE PATIENT. IT WAS ASSESSED THAT BECAUSE ANY DISCOVERED NON-CONFORMANCES WERE PROPERLY DISPOSITIONED BEFORE QC RELEASE, THERE IS EVIDENCE THAT THE DHR WAS FULLY EXECUTED. 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. ACCORDING TO THE INSTRUCTION FOR USE POTENTIAL ADVERSE EVENTS THAT MAY OCCUR INCLUDE, BUT ARE NOT LIMITED TO, THE FOLLOWING: FAILURE OF FILTER EXPANSION/INCOMPLETE EXPANSION THERE ARE ADEQUATE CONTROLS IN PLACE TO ENSURE THE DEVICE WAS MANUFACTURED TO SPECIFICATIONS. BASED ON THE PROVIDED INFORMATION AN EXACT CAUSE CANNOT BE ESTABLISHED. HOWEVER, IF THROMBUS WERE PRESENT IN DEPLOYMENT AREA IT COULD PREVENT THE FILTER FROM EXPANDING PROPERLY BUT THIS IS PURELY SPECULATIONS.

    Description of Event or Problem · 0

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE FILTER ITSELF DID NOT OPEN UP. IT DID NOT EXPAND TO THE CAVA WALLS. THEY REMOVED IT AND SUCCESSFULLY COMPLETED THE PROCEDURE WITH ANOTHER DEVICE OF THE SAME TYPE. PATIENT OUTCOME: ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158959 COOK CELECT® PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE G34309 E4052904 10827002343099

    Patients

    Seq Age Sex Outcome Treatment
    1 Male