BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK CELECT® PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET

    MDR report key: 5976282 · Received September 26, 2016

    Report

    Report Number
    3002808486-2016-01146
    Event Type
    Malfunction
    Date Received
    September 26, 2016
    Date of Event
    May 31, 2016
    Report Date
    September 6, 2016
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    PMA / PMN Number
    K121629
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CATOLOG # IGTCFS-65-1-JUG-CELECT-PT. (B)(4). INVESTIGATION IS STILL IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). CATALOG # IGTCFS-65-1-JUG-CELECT-PT. (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: A CELECT-PT FILTER WAS PLACED WITH A 13° OF LEFTWARD TILT AND DURING RETRIEVAL APPROX. 3 MONTHS LATER THE TILT WAS UNCHANGED, BUT 2 OF THE RIGHT LATERAL MOST SECONDARY LEGS HAD PENETRATED THE IVC WALL AND EXTENDED APPROX. 10MM OUTSIDE THE COLUMN OF CONTRAST. THE REPORTED "UNEVEN DISTRIBUTION OF THE FILTER LEGS", WAS LIKELY A REFLECTION OF THE LATERAL DISPLACEMENT OF THE TWO SECONDARY LEGS DUE TO THEIR PERFORATION, AND NOT AN UNEVEN DISTRIBUTION THROUGHOUT THE LUMEN OF THE IVC. NO REPORTS OF SYMPTOMS TO THE PATIENT AND THE FILTER WAS SUCCESSFULLY RETRIEVED. FILTER TILT IS A KNOWN RISK IN RELATION TO FILTER IMPLANT REPORTED IN THE PUBLISHED SCIENTIFIC LITERATURE AND MAY OCCUR DURING PLACEMENT OR DURING IMPLANTING PERIOD. FILTER PERFORATION OF THE VENA CAVA WALL IS A KNOWN RISK REPORTED IN THE PUBLISHED SCIENTIFIC LITERATURE. ALSO, PUBLISHED SCIENTIFIC LITERATURE DESCRIBES THAT MANIPULATION IN THE AREA OF FILTER PLACEMENT COULD CONTRIBUTE TO CHANGES TO THE FILTER CONFIGURATION AND PLACEMENT THEREBY POTENTIALLY INITIATE PERFORATION OF THE VENA CAVA 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 OF EVENT ACCORDING TO STUDY: ON (B)(6) 2016, DURING THE INDEX PROCEDURE THE PATIENT HAD A CELECT® FILTER PLACED. THE INFERIOR VENA CAVA (IVC) DIAMETER AT THE INTENDED FILTER LOCATION WAS 25.0 MM. THERE WAS NO IVC ANATOMIC ANOMALY OR PRESENCE OF THROMBUS IN THE IVC PRIOR TO FILTER PLACEMENT. 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 PE. 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 6-< 11 DEGREES. THERE WAS NO EXTRAVASATION OF CONTRAST BUT FILTER LEGS DID APPEAR OUTSIDE THE COLUMN OF CONTRAST AFTER FILTER PLACEMENT. ANALYSIS OF THE PLACEMENT PROCEDURE VENACAVAGRAM REVEALED NO IVC ANATOMIC ANOMALY OR PRESENCE OF THROMBUS IN THE IVC PRIOR TO FILTER PLACEMENT. THE FILTER WAS PLACED IN THE IVC INFRARENAL SITE AND THE IVC DIAMETER WAS 20.8 MM. THERE WAS NO EVIDENCE OF FILTER MIGRATION, EXTRAVASATION OF CONTRAST, OR DEFORMATION. FILTER LEGS DID APPEAR OUTSIDE THE COLUMN OF CONTRAST AFTER FILTER PLACEMENT. THE ANGLE OF FILTER TILT IN THE AP VIEW WAS 11.8 DEGREES. ON THE SAME DAY, THE POST-PROCEDURE X-RAY WAS COMPLETED AND REVEALED NO EVIDENCE OF FILTER FRACTURE, EMBOLIZATION OR MIGRATION. FILTER TILT WAS < 6 DEGREES. ANALYSIS OF THE POST-PROCEDURE X-RAY REPORTED NO FRACTURE, DEFORMATION, EMBOLIZATION OR MIGRATION. FILTER TILT OF 5.0 DEGREES IN AP VIEW AND 5.6 DEGREES IN THE LAT VIEW. ON (B)(6) 2016 (92 DAYS POST-PROCEDURE), THE PRE-RETRIEVAL PROCEDURE X-RAY WAS COMPLETED AND SITE INDICATED NO FRACTURE, EMBOLIZATION OR MIGRATION, WITH A FILTER TILT OF <6 DEGREES. THE FILTER WAS NO LONGER CLINICALLY INDICATED AND WAS RETRIEVED ENDOVASCULARLY WITHOUT DIFFICULTY. ANALYSIS OF THE PRE-RETRIEVAL PROCEDURE X-RAY REVEALED NO EVIDENCE OF FILTER FRACTURE, EMBOLIZATION OR MIGRATION. FILTER TILT OF 7.6 DEGREES IN AP VIEW AND 4.2 DEGREES IN THE LAT VIEW. FILTER DEFORMATION WAS REPORTED: UNEVEN DISTRIBUTION OF FILTER LEGS. PATIENT OUTCOME: THE IVC FILTER WAS REMOVED ENDOVASCULARLY WITHOUT PROBLEMS AND THE PATIENT REMAINED IN THE STUDY UNTIL THE ONE MONTH POST-RETRIEVAL FOLLOW-UP WAS COMPLETED AND THE PATIENT COMPLETED THE STUDY.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO STUDY: ON (B)(6) 2016, DURING THE INDEX PROCEDURE THE PATIENT HAD A CELECT® FILTER PLACED. THE INFERIOR VENA CAVA (IVC) DIAMETER AT THE INTENDED FILTER LOCATION WAS 25.0 MM. THERE WAS NO IVC ANATOMIC ANOMALY OR PRESENCE OF THROMBUS IN THE IVC PRIOR TO FILTER PLACEMENT. 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 PE. 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 6-< 11 DEGREES. THERE WAS NO EXTRAVASATION OF CONTRAST BUT FILTER LEGS DID APPEAR OUTSIDE THE COLUMN OF CONTRAST AFTER FILTER PLACEMENT. ANALYSIS OF THE PLACEMENT PROCEDURE VENACAVAGRAM REVEALED NO IVC ANATOMIC ANOMALY OR PRESENCE OF THROMBUS IN THE IVC PRIOR TO FILTER PLACEMENT. THE FILTER WAS PLACED IN THE IVC INFRARENAL SITE AND THE IVC DIAMETER WAS 20.8 MM. THERE WAS NO EVIDENCE OF FILTER MIGRATION, EXTRAVASATION OF CONTRAST, OR DEFORMATION. FILTER LEGS DID APPEAR OUTSIDE THE COLUMN OF CONTRAST AFTER FILTER PLACEMENT. THE ANGLE OF FILTER TILT IN THE AP VIEW WAS 11.8 DEGREES. ON THE SAME DAY, THE POST-PROCEDURE X-RAY WAS COMPLETED AND REVEALED NO EVIDENCE OF FILTER FRACTURE, EMBOLIZATION OR MIGRATION. FILTER TILT WAS < 6 DEGREES. ANALYSIS OF THE POST-PROCEDURE X-RAY REPORTED NO FRACTURE, DEFORMATION, EMBOLIZATION OR MIGRATION. FILTER TILT OF 5.0 DEGREES IN AP VIEW AND 5.6 DEGREES IN THE LAT VIEW. ON (B)(6) 2016 (92 DAYS POST-PROCEDURE), THE PRE-RETRIEVAL PROCEDURE X-RAY WAS COMPLETED AND SITE INDICATED NO FRACTURE, EMBOLIZATION OR MIGRATION, WITH A FILTER TILT OF <6 DEGREES. THE FILTER WAS NO LONGER CLINICALLY INDICATED AND WAS RETRIEVED ENDOVASCULARLY WITHOUT DIFFICULTY. ANALYSIS OF THE PRE-RETRIEVAL PROCEDURE X-RAY REVEALED NO EVIDENCE OF FILTER FRACTURE, EMBOLIZATION OR MIGRATION. FILTER TILT OF 7.6 DEGREES IN AP VIEW AND 4.2 DEGREES IN THE LAT VIEW. FILTER DEFORMATION WAS REPORTED: UNEVEN DISTRIBUTION OF FILTER LEGS. PATIENT OUTCOME: THE IVC FILTER WAS REMOVED ENDOVASCULARLY WITHOUT PROBLEMS AND THE PATIENT REMAINED IN THE STUDY UNTIL THE ONE MONTH POST-RETRIEVAL FOLLOW-UP WAS COMPLETED AND THE PATIENT COMPLETED THE STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627841 COOK CELECT® PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR