BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK CELECT® PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET

    MDR report key: 5696740 · Received June 3, 2016

    Report

    Report Number
    3002808486-2016-00398
    Event Type
    Malfunction
    Date Received
    June 3, 2016
    Date of Event
    January 13, 2015
    Report Date
    January 16, 2015
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    UDI-DI
    10827002343099
    PMA / PMN Number
    K121629
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). CATALOG#: IGTCFS-65-1-JUG-CELECT-PT. (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: FOLLOW-UP CT SCAN DEMONSTRATES: NO EVIDENCE OF PULMONARY EMBOLISM; GRADE 1 INTERACTION BETWEEN ALL 4 OF THE PRIMARY FILTER LEGS AS WELL AS 3 OF THE SECONDARY FILTER LEGS, WITH THE WALL OF THE IVC; NO EVIDENCE OF PERICAVAL INFLAMMATORY CHANGES TO SUGGEST PENETRATION; POST-RETRIEVAL, MILD NARROWING OF THE IVC IN THE REGION OF THE PRIMARY FILTER, LIKELY REPRESENTING SPASM FROM RETRIEVAL THE FILTER; NO EVIDENCE OF EXTRAVASATION POST-RETRIEVAL. 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. AS STATED IN THE IMPRESSIONS, THE OVERALL PATTERN IS MORE SUGGESTIVE OF TENTING RATHER THAN TRUE PENETRATION. BASED ON THE INVESTIGATION, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THIS EVENT. THERE IS 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. 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: THE INFERIOR VENA CAVA (IVC) DIAMETER AT THE INTENDED FILTER LOCATION WAS 16 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 (LOT # E3249383) WAS DEPLOYED AT THE INTENDED LOCATION IN THE IVC INFRARENAL SITE AND IN A LOCATION SUITABLE TO PROVIDE SUFFICIENT MECHANICAL PROTECTION AGAINST PULMONARY EMBOLISM (PE). THE FILTER NEITHER DEPLOYED PREMATURELY NOR DID THE FILTER JUMP UPON DEPLOYMENT. THERE WAS NO EVIDENCE OF FILTER FRACTURE, DEFORMATION, MIGRATION, OR EXTRAVASATION OF CONTRAST AFTER FILTER PLACEMENT. FILTER LEGS DID APPEAR OUTSIDE THE COLUMN OF CONTRAST AFTER FILTER PLACEMENT. THE FILTER ANGLE OF TILT WAS 6 TO < 11 DEGREES. 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 AT THE FILTER LOCATION WAS 15.3 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 3.7 DEGREES. ON (B)(6) 2015 PRE-RETRIEVAL CT (68 DAYS POST-PROCEDURE): SITE: GRADE 1 FILTER LEG INTERACTION WITH IVC WALL. ANALYSIS: NUMBER OF FILTER LEGS WITH GRADE 1: ELEVEN NUMBER OF FILTER LEGS WITH GRADE 2: ZERO NUMBER OF FILTER LEGS WITH GRADE 3: ZERO PATIENT OUTCOME: ON (B)(6) 2015 (68 DAYS POST-PROCEDURE), THE FILTER WAS RETRIEVED ENDOVASCULARLY, VIA THE RIGHT INTERNAL JUGULAR VEIN, WITH NO DIFFICULTY. THERE WAS NO EXTRAVASATION OF CONTRAST AFTER FILTER RETRIEVAL.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO STUDY: THE INFERIOR VENA CAVA (IVC) DIAMETER AT THE INTENDED FILTER LOCATION WAS 16 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 (LOT # E3249383) WAS DEPLOYED AT THE INTENDED LOCATION IN THE IVC INFRARENAL SITE AND IN A LOCATION SUITABLE TO PROVIDE SUFFICIENT MECHANICAL PROTECTION AGAINST PULMONARY EMBOLISM (PE). THE FILTER NEITHER DEPLOYED PREMATURELY NOR DID THE FILTER JUMP UPON DEPLOYMENT. THERE WAS NO EVIDENCE OF FILTER FRACTURE, DEFORMATION, MIGRATION, OR EXTRAVASATION OF CONTRAST AFTER FILTER PLACEMENT. FILTER LEGS DID APPEAR OUTSIDE THE COLUMN OF CONTRAST AFTER FILTER PLACEMENT. THE FILTER ANGLE OF TILT WAS 6 TO < 11 DEGREES. 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 AT THE FILTER LOCATION WAS 15.3 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 3.7 DEGREES. ON (B)(6) 2015 PRE-RETRIEVAL CT (68 DAYS POST-PROCEDURE): SITE: GRADE 1 FILTER LEG INTERACTION WITH IVC WALL. ANALYSIS: NUMBER OF FILTER LEGS WITH GRADE 1: ELEVEN; NUMBER OF FILTER LEGS WITH GRADE 2: ZERO; NUMBER OF FILTER LEGS WITH GRADE 3: ZERO. PATIENT OUTCOME: ON (B)(6) 2015 (68 DAYS POST-PROCEDURE), THE FILTER WAS RETRIEVED ENDOVASCULARLY, VIA THE RIGHT INTERNAL JUGULAR VEIN, WITH NO DIFFICULTY. THERE WAS NO EXTRAVASATION OF CONTRAST AFTER FILTER RETRIEVAL. THE PATIENT HAS EXITED THE CLINICAL STUDY. NO DEVICE RELATED ADVERSE EVENTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354251 COOK CELECT® PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE 10827002343099

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other