BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN OPTEASE VENA CAVA FILTER

    MDR report key: 2855008 · Received December 3, 2012

    Report

    Report Number
    9616099-2012-00717
    Event Type
    Injury
    Date Received
    December 3, 2012
    Date of Event
    November 1, 2006
    Report Date
    November 6, 2012
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DTK
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THE EVENT DATE IS BEING REPORTED AS (B)(6) 2006 AS THE ARTICLE WAS FROM (B)(6) 2006. PLEASE NOTE THAT THIS REPORT REPRESENTS NOTIFICATION OF TWELVE SEPARATE EVENTS INVOLVING THROMBOSIS IN DEVICE FROM A LITERATURE REVIEW SOURCE AND FOR WHICH SPECIFIC PATIENT INFORMATION WAS NOT AVAILABLE. AN INVESTIGATION IS UNDERWAY TO OBTAIN THIS INFORMATION. THE PRODUCT IS NOT AVAILABLE FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. (B)(4). PLEASE REFERENCE MFR. REPORT # 9616099-2012-00716, # 9616099-2012-00717, # 9616099-2012-00718.

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: DURING A LITERATURE SEARCH, THE FOLLOWING ARTICLE WAS FOUND IN EUR J VASC ENDOVASC SURG 32, 589E595 (2006) DOI:10.1016/J.EJVS.2006.04.040. THE ARTICLE WAS ENTITLED: EARLY EXPERIENCE WITH THE RETRIEVABLE OPTEASE VENA CAVA FILTER IN HIGH-RISK TRAUMA PATIENTS BY C. MEIER, I.S. KELLER, R. PFIFFNER, L. LABLER, O. TRENTZ AND T. PFAMMATTER. DIVISION OF TRAUMA SURGERY, AND INSTITUTE OF DIAGNOSTIC RADIOLOGY, UNIVERSITY HOSPITAL ZURICH, SWITZERLAND. THE REPORT INDICATED THAT THIRTY-THREE (33) PATIENTS UNDERWENT INFERIOR CAVOGRAPHY BEFORE RETRIEVAL AND THAT TWELVE (12) FILTERS PRESENTED WITH STRANDS OF ORGANIZED THROMBUS ON THE FILTER STRUTS (36%). THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. ADDITIONALLY, AS THE STERILE LOT NUMBER WAS NOT AVAILABLE, DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. BASED ON THE LACK OF INFORMATION AND THE INABILITY TO ASSIGN OR DETERMINE A ROOT CAUSE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. 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. FACTORS THAT MAY HAVE INFLUENCED THE EVENT INCLUDE PATIENT, PHARMACOLOGICAL AND LESION. NO CORRECTIVE OR PREVENTIVE ACTION WILL BE TAKEN, GIVEN THAT; WITH THE INFORMATION PROVIDED THE REPORTED FAILURE DOES NOT APPEAR TO BE RELATED TO THE MANUFACTURING PROCESS. PLEASE REFERENCE MFR. REPORT # 9616099-2012-00716, # 9616099-2012-00717, # 9616099-2012-00718.

    Description of Event or Problem · 1

    DURING A LITERATURE SEARCH, THE FOLLOWING ARTICLE WAS FOUND IN EUR J VASC ENDOVASC SURG 32, 589E595 (2006) DOI:10.1016/J.EJVS.2006.04.040. THE ARTICLE WAS ENTITLED: EARLY EXPERIENCE WITH THE RETRIEVABLE OPTEASE VENA CAVA FILTER IN HIGH-RISK TRAUMA PATIENTS BY C. MEIER, I.S. KELLER, R. PFIFFNER, L. LABLER, O. TRENTZ AND T. PFAMMATTER. DIVISION OF TRAUMA SURGERY, AND INSTITUTE OF DIAGNOSTIC RADIOLOGY, UNIVERSITY HOSPITAL ZURICH, SWITZERLAND. THE REPORT INDICATED THAT THIRTY-THREE (33) PATIENTS UNDERWENT INFERIOR CAVOGRAPHY BEFORE RETRIEVAL AND THAT TWELVE (12) FILTERS PRESENTED WITH STRANDS OF ORGANIZED THROMBUS ON THE FILTER STRUTS (36%). TWO PATIENTS RECEIVED ANTICOAGULATION BEFORE FILTER RETRIEVAL DUE TO FILTER THROMBOSIS (6%).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening