BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN OPTEASE VENA CAVA FILTER

    MDR report key: 4874738 · Received June 29, 2015

    Report

    Report Number
    9616099-2015-00258
    Event Type
    Death
    Date Received
    June 29, 2015
    Date of Event
    May 1, 2015
    Report Date
    June 5, 2015
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DTK
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). LITERATURE CITATION: LAVAN ET AL (2015). THE USE OF OPTIONAL INFERIOR VENA CAVA FILTERS OF TYPE OPTEASE IN TRAUMA-PATIENTS- A SINGLE TYPE OF FILTER IN A SINGLE MEDICAL CENTER. THROMBOSIS RESEARCH, 135, 873-876. THE PUBLICATION HAS BEEN ATTACHED TO THIS REPORT. DUE TO THE TYPE OF COMPLAINT, THE EVENT DATE IS NOT ACCURATE. COMPLAINT CONCLUSION: AS NOTED IN A PUBLICATION, THE USE OF OPTIONAL INFERIOR VENA CAVA FILTERS OF TYPE OPTEASE IN TRAUMA-PATIENTS- A SINGLE TYPE OF FILTER IN A SINGLE MEDICAL CENTER. A (B)(6) MALE RECEIVED PROPHYLACTICALLY IVC FILTER TYPE OPTEASE FOLLOWING HEAD TRAUMA. THIRTEEN DAYS LATER ACUTE IVC THROMBOSIS WITH PHLEGMASIS CERULEA DOLLENS WAS NOTICED. HE DEVELOPED PE AND BILATERAL PHELGMASIA CERULEA DOLENS WITH ISCHEMIC FOOT DUE TO EXTENSIVE THROMBOSIS OF IVC AND BILATERAL ILEO FEMORAL VEIN THROMBOSIS. THIS PATIENT DIED BECAUSE OF MASSIVE THROMBOSIS THAT CULMINATED IN MULTI-ORGAN FAILURE. THE PATIENT RECEIVED UROKINASE TREATMENT FOR THE PHLEGMASIA DOLENS IN SPITE OF THE ABSOLUTE CONTRAINDICATION TO THE USE OF THROMBOLYTIC AGENTS IN TRAUMA PATIENTS. THE STERILE LOT NUMBER OF THE DEVICE IS UNKNOWN THEREFORE A DEVICE HISTORY REPORT REVIEW COULD NOT BE CONDUCTED. THE PURPOSE OF A VENA CAVA FILTER IS TO CATCH THROMBUS FROM THE LOWER EXTREMITIES AS IT TRAVELS ALONG NORMAL BLOOD FLOW PATTERNS UP TOWARDS THE HEART. THROMBUS IN THE FILTER DOES NOT REPRESENT A DEVICE MALFUNCTION. THROMBOSIS IN THE FILTER IS A WELL-KNOWN POTENTIAL COMPLICATION AND OCCURS IN APPROXIMATELY 3.6 TO 11.2 % OF ALL PATIENTS¿. THERE IS NO INFORMATION TO SUGGEST THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE, THEREFORE, NO CORRECTIVE ACTION WILL BE TAKEN. - ATTACHMENT: [PUBLICATION (1).PDF]

    Description of Event or Problem · 1

    AS NOTED IN A PUBLICATION, THE USE OF OPTIONAL INFERIOR VENA CAVA FILTERS OF TYPE OPTEASE IN TRAUMA-PATIENTS- A SINGLE TYPE OF FILTER IN A SINGLE MEDICAL CENTER. A (B)(6) MALE RECEIVED PROPHYLACTICALLY IVC FILTER TYPE OPTEASE FOLLOWING HEAD TRAUMA. THIRTEEN DAYS LATER ACUTE IVC THROMBOSIS WITH PHLEGMASIS CERULEA DOLLENS WAS NOTICED. HE DEVELOPED PE AND BILATERAL PHELGMASIA CERULEA DOLENS WITH ISCHEMIC FOOT DUE TO EXTENSIVE THROMBOSIS OF IVC AND BILATERAL ILEO FEMORAL VEIN THROMBOSIS. THIS PATIENT DIED BECAUSE OF MASSIVE THROMBOSIS THAT CULMINATED IN MULTI-ORGAN FAILURE AND SEPSIS. THE PATIENT RECEIVED UROKINASE TREATMENT FOR THE PHLEGMASIA DOLENS IN SPITE OF THE ABSOLUTE CONTRAINDICATION TO THE USE OF THROMBOLYTIC AGENTS IN TRAUMA PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419599 UNKNOWN OPTEASE VENA CAVA FILTER THROMBECTOMY SYSTEMS (DTK) DTK CORDIS CORPORATION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Death| R