BEUDAMED
    FDA Adverse Event Death Summary report: N

    COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET

    MDR report key: 5902809 · Received August 25, 2016

    Report

    Report Number
    3002808486-2016-00928
    Event Type
    Death
    Date Received
    August 25, 2016
    Date of Event
    July 29, 2015
    Report Date
    August 4, 2015
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    UDI-DI
    10827002345048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CATALOG # IGTCFS-65-2-UNI-CELECT-PT. SIMILAR TO DEVICE UNDER 510(K) K121629. SUMMARY OF INVESTIGATIONAL FINDINGS: EVALUATION IS BASED ON THE DESCRIPTION OF EVENT AND THE IMAGING RECEIVED. THREE IMAGES FROM IMPLANTATION ARE PROVIDED ALONG WITH THE COMPLAINT REPORT. THE FILTER WAS IMPLANTED IN A NORMAL INFRARENAL IVC WITHOUT TILT AND WITH UNIFORM LEG DISTRIBUTION. IMAGING OF THE REPORTED IVC THROMBOSIS IN AND SUPERIOR THE FILTER WAS NOT PROVIDED. THE THROMBUS LIKELY WAS NOT RELATED TO A FILTER ABNORMALITY. PE IS A KNOWN RISK IN RELATION TO FILTER IMPLANT REPORTED IN THE PUBLISHED SCIENTIFIC LITERATURE. THERE IS NO EVIDENCE TO SUGGEST THAT THIS DEVICE WAS NOT MANUFACTURED ACCORDING TO SPECIFICATIONS. COOK VISITED THE HOSPITAL AFTER THIS INCIDENT AND DURING THIS VISIT THE CONSULTANT DR. SAID "THE FILTER DID ITS JOB, BUT THE CLOT WAS SO BIG, THAT IT INTRUDED THE FILTER. THE FILTER HASN¿T MOVED, BUT THERE ARE CLOTS IN AND AROUND THE FILTER" AND "HE STRONGLY BELIEVES THE FILTER WAS NOT FAULTY AND NO FILTER COULD HAVE PREVENTED THIS". BASED ON THE ABOVE AND THE EVALUATION OF THE IMAGING IT IS CONCLUDED THAT THE FILTER FUNCTION WAS NOT RELATED TO THIS OCCURRENCE. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO COMPLAINANT: PATIENT WAS BROUGHT TO VIU FOR A PREOPERATIVE IVC FILTER PLACEMENT PRIOR TO A RIGHT HEMICOLECTOMY. A RIGHT FEMORAL PUNCTURE WAS MADE AND A VENOGRAM WAS DONE. THERE WAS NO EVIDENCE OF CLOT IN THE CAVA AFTER THE VENOGRAM AND THE CONSULTANT WAS HAPPY TO PROCEED. THE FILTER PLACEMENT WAS ROUTINE AND UNEVENTFUL. THE POST PLACEMENT VENOGRAM WAS NORMAL AND THE PATIENT WAS SENT TO RECOVERY AND THEN MOVED BACK TO THE WARD. ON (B)(6), PATIENT WENT FOR A PREOPERATIVE ASSESSMENT AND PROCEEDED IN TO HIS SURGERY WHICH WAS FOR A RIGHT HEMICOLECTOMY. THE SURGERY WENT TO PLAN AND THERE WERE NO COMPLICATIONS TO REPORT. THEN ON (B)(6), THE PATIENT DIED OF A SUSPECTED PULMONARY EMBOLISM. PATIENT OUTCOME: PATIENT DEATH CAUSED BY POSSIBLE PE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    557014 COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE 10827002345048

    Patients

    Seq Age Sex Outcome Treatment
    1 Death