BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK CELECT® PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET

    MDR report key: 5658806 · Received May 17, 2016

    Report

    Report Number
    3002808486-2016-00261
    Event Type
    Malfunction
    Date Received
    May 17, 2016
    Date of Event
    March 11, 2016
    Report Date
    April 20, 2016
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    UDI-DI
    10827002343105
    PMA / PMN Number
    K121629
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CATALOG#: IGTCFS-65-2-JUG-CELECT-PT. INVESTIGATION IS STILL IN PROGRESS.

    Additional Manufacturer Narrative · 1

    MANUFACTURER REF#: (B)(4). IGTCFS-65-2-JUG-CELECT-PT. (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: THERE IS A DISCREPANCY BETWEEN THE REPORTED. ANALYSES REPORTS SIGNIFICANT FILTER TILT, BUT THIS IS NOT REPORTED BY THE SITE AND NOT SUPPORTED BY IMAGE REVIEW. ANALYSIS SEEMS TO BE REPORTING FILTER TILT WHEN MEASURING TILT AGAINST THE SPINOUS PROCESSES, AND NOT IN RELATION TO THE IVC AS SUPPOSED TO, PERHAPS DUE TO THE USE OF X-RAY IMAGES WITH LOW OR NO VISIBILITY OF VEINS. VENOGRAM IMAGING SHOWS THAT IN THIS PATIENT THE IVC HAS AN APPROXIMATELY 22° DEGREE CURVATURE AND THUS IS NOT FOLLOWING THE COURSE OF THE SPINOUS PROCESSES, AND THAT FILTER TILT MEASURED AGAINST THE COURSE OF THE IVC AT SITE OF FILTER IMPLANT IS ABOUT 1°, WHICH IS INSIGNIFICANT. WETHER TILT (WHEN MEASURED AGAINST IVC) AT ANY TIME AND IN ANY VIEW ACTUALLY HAS BEEN PRESENT TO A SIGNIFICANT DEGREE IS NOT CLEAR, BUT FILTER TILT IS A KNOWN RISK IN RELATION TO FILTER IMPLANT REPORTED IN THE PUBLISHED SCIENTIFIC LITERATURE. IT IS NOTED THAT THE PATIENT WAS NOT HARMED AND THAT THE FILTER WAS REMOVED SUCCESSFULLY. THERE IS FOUND 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: THE PRIMARY REASON FOR THE FILTER PLACEMENT WAS A CURRENT DVT WITH A COMPLICATION OF ANTICOAGULATION. USING THE RIGHT INTERNAL JUGULAR VEIN AS THE ACCESS SITE, 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 PULMONARY EMBOLISM. THE FILTER NEITHER DEPLOYED PREMATURELY NOR DID THE FILTER JUMP UPON DEPLOYMENT. THERE WAS NO EVIDENCE OF FILTER FRACTURE, DEFORMATION, OR MIGRATION. THERE WAS NO EXTRAVASATION OF CONTRAST OR FILTER LEGS APPEARING OUTSIDE THE COLUMN OF CONTRAST AFTER FILTER PLACEMENT. THE FILTER ANGLE OF TILT WAS < 6 DEGREES. ON THE SAME DAY, THE POST-PROCEDURE X-RAY REVEALED THE ANGLE OF FILTER TILT IN THE AP VIEW WAS 20.6 DEGREES AND IN THE LAT VIEW 6.4 DEGREES. ON (B)(6) 2016 (60 DAYS POST-PROCEDURE), THE PRE-RETRIEVAL X-RAY WAS PERFORMED AND REVEALED NO EVIDENCE OF FILTER FRACTURE, EMBOLIZATION, OR MIGRATION. THE FILTER TILT WAS < 6 DEGREES. CORE LAB ANALYSIS OF THE PRE-RETRIEVAL X-RAY REVEALED NO EVIDENCE OF FILTER FRACTURE, DEFORMATION, EMBOLIZATION, OR MIGRATION. THE ANGLE OF FILTER TILT IN THE AP VIEW WAS 22.5 DEGREES AND 11 DEGREES IN THE LAT VIEW. ON THE SAME DAY, THE FILTER WAS RETRIEVED WITH NO DIFFICULTY. THERE WAS NO THROMBUS PRESENT AND FILTER LEGS DID NOT APPEAR OUTSIDE THE COLUMN OF CONTRAST BEFORE RETRIEVAL. RETRIEVAL WAS ACCOMPLISHED ENDOVASCULARLY WITH A GÜNTHER TULIP¿ RETRIEVAL SET VIA THE RIGHT INTERNAL JUGULAR VEIN. THERE WAS NO EXTRAVASATION OF CONTRAST AFTER FILTER RETRIEVAL. PATIENT OUTCOME: THE PATIENT HAS EXITED THE STUDY.

    Description of Event or Problem · 1

    DESCRIPTION ACCORDING TO STUDY: THE PRIMARY REASON FOR THE FILTER PLACEMENT WAS A CURRENT DVT WITH A COMPLICATION OF ANTICOAGULATION. USING THE RIGHT INTERNAL JUGULAR VEIN AS THE ACCESS SITE, 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 PULMONARY EMBOLISM. THE FILTER NEITHER DEPLOYED PREMATURELY NOR DID THE FILTER JUMP UPON DEPLOYMENT. THERE WAS NO EVIDENCE OF FILTER FRACTURE, DEFORMATION, OR MIGRATION. THERE WAS NO EXTRAVASATION OF CONTRAST OR FILTER LEGS APPEARING OUTSIDE THE COLUMN OF CONTRAST AFTER FILTER PLACEMENT. THE FILTER ANGLE OF TILT WAS 6 DEGREES. ON THE SAME DAY, THE POST-PROCEDURE X-RAY REVEALED THE ANGLE OF FILTER TILT IN THE AP VIEW WAS 20.6 DEGREES AND IN THE LAT VIEW 6.4 DEGREES. ON (B)(6) 2016 (60 DAYS POST-PROCEDURE), THE PRE-RETRIEVAL X-RAY WAS PERFORMED AND REVEALED NO EVIDENCE OF FILTER FRACTURE, EMBOLIZATION, OR MIGRATION. THE FILTER TILT WAS 6 DEGREES. CORE LAB ANALYSIS OF THE PRE-RETRIEVAL X-RAY REVEALED NO EVIDENCE OF FILTER FRACTURE, DEFORMATION, EMBOLIZATION, OR MIGRATION. THE ANGLE OF FILTER TILT IN THE AP VIEW WAS 22.5 DEGREES AND 11 DEGREES IN THE LAT VIEW. ON THE SAME DAY, THE FILTER WAS RETRIEVED WITH NO DIFFICULTY. THERE WAS NO THROMBUS PRESENT AND FILTER LEGS DID NOT APPEAR OUTSIDE THE COLUMN OF CONTRAST BEFORE RETRIEVAL. RETRIEVAL WAS ACCOMPLISHED ENDOVASCULARLY WITH A GÜNTHER TULIP¿ RETRIEVAL SET VIA THE RIGHT INTERNAL JUGULAR VEIN. THERE WAS NO EXTRAVASATION OF CONTRAST AFTER FILTER RETRIEVAL. PATIENT OUTCOME: THE PATIENT HAS EXITED THE STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316570 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 71 YR Other