BEUDAMED
    FDA Adverse Event Death Summary report: N

    COOK CELECT NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTERS

    MDR report key: 5902779 · Received August 25, 2016

    Report

    Report Number
    3002808486-2016-00923
    Event Type
    Death
    Date Received
    August 25, 2016
    Report Date
    July 20, 2011
    Manufacturer
    WILLIAM COOK EUROPE
    Product Code
    DTK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CATALOG#: IGTCFS-65-2-UNI-CELECT. SIMILAR TO DEVICE UNDER 510(K) K090140. (B)(4). SUMMARY OF INVESTIGATIONAL FINDINGS: INVESTIGATION IS BASED ON EVENT DESCRIPTION, SINCE NO IMAGES OR INFORMATION OF THE PRODUCT HAVE BEEN AVAILABLE. NO PRODUCT WAS RETURNED. ACCORDING TO THE DESCRIPTION, ONE FOOT HAS PERFORATED VENA CAVA WALL AND THE PATIENT WAS BLEEDING FROM A NUMBER OF SITES. THE PATIENT EXPIRED. HOWEVER, THE PATIENT WAS EXCESSIVELY ANTI-COAGULATED. CONCLUSIVELY, THE EXACT ROOT CAUSE IS UNKNOWN BASED ON THE LIMITED INFORMATION. SEVERAL CASE REPORTS PUBLISHED IN LITERATURE, DESCRIBE FILTER PERFORATION OF THE VENA CAVA WALL AS A WELL-KNOWN RISK. DESPITE PERFORATION, THEY ALL END UP IN SUCCESSFUL FILTER RETRIEVAL. NO PRODUCT LOT HAS BEEN AVAILABLE FOR THE INVESTIGATION. COOK MEDICAL WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    DESCRIPTION OF EVENT ACCORDING TO COMPLAINANT: THE FILTER WAS PLACED WITHOUT APPARENT DIFFICULTY OR PROBLEM BUT ONE OF THE FEET DID BREACH THE WALL OF THE IVC. UNFORTUNATELY THE PATIENT WAS EXCESSIVELY ANTICOAGULATED AND BLED FROM A NUMBER OF SITES INCLUDING INTO THE RETROPERITONEUM. HENCE THE FILTER HAS IN PART BEEN IMPLICATED AS CAUSE OF DEATH. PATIENT OUTCOME: PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556323 COOK CELECT NAVALIGN JUGULAR & FEMORAL VENA CAVA FILTERS DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK WILLIAM COOK EUROPE

    Patients

    Seq Age Sex Outcome Treatment
    1 Death