BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET

    MDR report key: 5895776 · Received August 23, 2016

    Report

    Report Number
    3002808486-2016-00939
    Event Type
    Injury
    Date Received
    August 23, 2016
    Date of Event
    June 5, 2015
    Report Date
    July 9, 2015
    Product Code
    DTK
    UDI-DI
    10827002345048
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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: BASED ON THE IMAGING REVIEW BILATERAL PE WAS DEMONSTRATED, BUT THE REPORTED DVT ~66 DAYS AFTER FILTER PLACEMENT COULD NOT BE CONFIRMED, AS REFERENCED ULTRASOUND WAS NOT PROVIDED. LT IS POSSIBLE BUT VERY UNLIKELY THE RIGHT LEG DVT WAS A RIGHT CFV ACCESS SITE COMPLICATION GIVEN THE NORMAL CFV ON ULTRASOUND PRE-IMPLANTATION AND THE LACK OF SYMPTOMS FOR TWO MONTHS FOLLOWING IMPLANTATION. 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. 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) 2015 (94 DAY POST-PROCEDURE), AN UNSCHEDULED ULTRASOUND WAS COMPLETED. THE ULTRASOUND REVEALED NO THROMBUS IN THE INFERIOR VENA CAVA (IVC) OR THE PELVIC VEINS. THERE WAS THROMBUS IN THE RIGHT LOWER EXTREMITIES. THIS IMAGING RESULT WAS ASSOCIATED WITH CLINICAL SEQUELAE AND LED TO AN INTERVENTION OR TREATMENT. THE EVENT WAS A RIGHT DEEP VEIN THROMBOSIS (DVT) FIRST DIAGNOSED ON (B)(6) 2015 (66 DAY POST-PROCEDURE) . THE PATIENT WAS TREATED WITH ANTICOAGULATION, WARFARIN AND DALTEPARIN. PATIENT OUTCOME: THE PATIENT REMAINS IN THE STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548481 COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK 10827002345048

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Life Threatening