BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK CELECT® PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET

    MDR report key: 6108737 · Received November 17, 2016

    Report

    Report Number
    3002808486-2016-01437
    Event Type
    Malfunction
    Date Received
    November 17, 2016
    Date of Event
    October 13, 2016
    Report Date
    November 14, 2016
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    UDI-DI
    10827002343105
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CATALOG#: IGTCFS-65-2-JUG-CELECT-PT. SIMILAR TO DEVICE WITH 510(K) K121626. INVESTIGATION IS STILL IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). CATALOG#: IGTCFS-65-2-JUG-CELECT-PT. SIMILAR TO DEVICE WITH 510(K) K121626. (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: A CELECT-PT FILTER WAS DEPLOYED IN AN INFRARENAL LOCATION WITH NO EVIDENCE OF SIGNIFICANT TILT. A FOLLOW-UP VENOGRAM WAS NOT PERFORMED AFTER DEPLOYMENT, BUT THE NEXT DAY ALL OF THE PRIMARY AND SECONDARY LEGS DEMONSTRATED GRADE 1 INTERACTION WITH THE IVC WALL. THE REPORTED GRADE 3 INTERACTION OF A PRIMARY LEG DOES NOT APPEAR ON THE PROVIDED IMAGES; ON THE MULTIPLANAR REFORMATS OF THE CT, THIS PRIMARY FILTER LEG IS NEVER SEEN EXTENDING OUTSIDE OF THE WALL OF THE IVC RATHER JUST SEVERELY TENTING IT. THE FILTER WAS RETRIEVED WITHOUT DIFFICULTY. GRADE 1 INTERACTION (CONFIRMED): FILTER STRUT IS IMMEDIATELY ADJACENT TO THE EXTERNAL ASPECT OF THE IVC WALL (LIKELY REFLECTING TENTING OF THE IVC WALL). NO EVIDENCE TO SUGGEST THAT THIS DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS AND NOTHING INDICATES THAT THE FILTER DID NOT PERFORM AS INTENDED, E.G. INTENDED FOR THE PREVENTION OF RECURRENT PULMONARY EMBOLISM (PE) VIA PLACEMENT IN THE VENA CAVA. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    DESCRIPTION ACCORDING TO STUDY: SITE REPORTED GRADE 1 FILTER LEG INTERACTION WITH IVC WALL. AT THE INDEX PROCEDURE ON (B)(6) 2016, THE PATIENT RECEIVED A CELECT FILTER. THE INFERIOR VENA CAVA (IVC) DIAMETER AT THE INTENDED FILTER LOCATION WAS 19 MM. THERE WAS NO IVC ANATOMIC ANOMALY AND NO THROMBUS WAS NOTED IN THE IVC PRIOR TO FILTER PLACEMENT. A CELECT® FILTER WAS DEPLOYED AT THE INTENDED LOCATION IN THE IVC INFRARENAL SITE AND IN A LOCATION SUITABLE TO PROVIDE SUFFICIENT MECHANICAL PROTECTION AGAINST PE. THE ACCESS SITE WAS THE RIGHT INTERNAL JUGULAR VEIN. THE FILTER NEITHER DEPLOYED PREMATURELY NOR DID THE FILTER JUMP UPON DEPLOYMENT. THERE WAS NO EVIDENCE OF FILTER FRACTURE, DEFORMATION, OR MIGRATION. FILTER TILT WAS 0 DEGREES. EXTRAVASATION OF CONTRAST OR FILTER LEGS APPEARING OUTSIDE THE COLUMN OF CONTRAST AFTER FILTER PLACEMENT WERE NOT ASSESSED. ON (B)(6) 2016 (DAY OF INDEX PROCEDURE), THE POST-PROCEDURE X-RAY WAS COMPLETED. THE SITE REPORTED NO EVIDENCE OF FILTER FRACTURE, EMBOLIZATION, OR MIGRATION. FILTER TILT WAS 0 DEGREES. ON (B)(6) 2016, (ONE DAY POST-PROCEDURE), THE PATIENT UNDERWENT AN UNSCHEDULED CT SCAN. THE SITE REPORTED FILTER LEG INTERACTION WITH IVC WALL, THE HIGHEST GRADE OBSERVED WAS 1. ON (B)(6) 2016 (21 DAYS POST-PROCEDURE), IT WAS DETERMINED THE FILTER WAS NO LONGER CLINICALLY NEEDED AND WAS RETRIEVED ENDOVASCULARLY WITHOUT DIFFICULTY. PATIENT OUTCOME: THE PATIENT REMAINS IN THE STUDY UNTIL 1 MONTH POST-RETRIEVAL CLINICAL VISIT IS COMPLETED.

    Description of Event or Problem · 1

    DESCRIPTION ACCORDING TO STUDY: SITE REPORTED GRADE 1 FILTER LEG INTERACTION WITH IVC WALL. AT THE INDEX PROCEDURE ON (B)(6) 2016 THE PATIENT RECEIVED A CELECT FILTER. THE INFERIOR VENA CAVA (IVC) DIAMETER AT THE INTENDED FILTER LOCATION WAS 19 MM. THERE WAS NO IVC ANATOMIC ANOMALY AND NO THROMBUS WAS NOTED IN THE IVC PRIOR TO FILTER PLACEMENT. A CELECT® FILTER WAS DEPLOYED AT THE INTENDED LOCATION IN THE IVC INFRARENAL SITE AND IN A LOCATION SUITABLE TO PROVIDE SUFFICIENT MECHANICAL PROTECTION AGAINST PE. THE ACCESS SITE WAS THE RIGHT INTERNAL JUGULAR VEIN. THE FILTER NEITHER DEPLOYED PREMATURELY NOR DID THE FILTER JUMP UPON DEPLOYMENT. THERE WAS NO EVIDENCE OF FILTER FRACTURE, DEFORMATION, OR MIGRATION. FILTER TILT WAS 0 DEGREES. EXTRAVASATION OF CONTRAST OR FILTER LEGS APPEARING OUTSIDE THE COLUMN OF CONTRAST AFTER FILTER PLACEMENT WERE NOT ASSESSED. ON (B)(6) 2016 (DAY OF INDEX PROCEDURE), THE POST-PROCEDURE X-RAY WAS COMPLETED. THE SITE REPORTED NO EVIDENCE OF FILTER FRACTURE, EMBOLIZATION, OR MIGRATION. FILTER TILT WAS 0 DEGREES. ON (B)(6) 2016, (ONE DAY POST-PROCEDURE), THE PATIENT UNDERWENT AN UNSCHEDULED CT SCAN. THE SITE REPORTED FILTER LEG INTERACTION WITH IVC WALL, THE HIGHEST GRADE OBSERVED WAS 1. ON (B)(6) 2016 (21 DAYS POST-PROCEDURE), IT WAS DETERMINED THE FILTER WAS NO LONGER CLINICALLY NEEDED AND WAS RETRIEVED ENDOVASCULARLY WITHOUT DIFFICULTY. PATIENT OUTCOME: THE PATIENT REMAINS IN THE STUDY UNTIL 1 MONTH POST-RETRIEVAL CLINICAL VISIT IS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761455 COOK CELECT® PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE 10827002343105

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR