BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN OPTEASE VENA CAVA FILTER

    MDR report key: 2852847 · Received November 30, 2012

    Report

    Report Number
    9616099-2012-00708
    Event Type
    Injury
    Date Received
    November 30, 2012
    Date of Event
    January 1, 2011
    Report Date
    November 6, 2012
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DTK
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: TAM ET AL DEVICE-RELATED COMPLICATIONS AND EFFECTIVENESS OF THE OPTEASE FILTER: A RETROSPECTIVE STUDY OF 149 CASES; CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGICAL SOCIETY OF EUROPE (CIRSE) 2011, REPORT THERE WAS 1 POST-FILTER PE, 9 DVTS AND 1 CAVAL OCCLUSION. THROMBUS WAS SEEN IN THE FILTER IN 12 CASES BUT THIS DID NOT PROGRESS TO OCCLUSION AND WAS ASYMPTOMATIC. THERE WERE 2 FRACTURES AND 2 CASES OF PENETRATION. THERE WAS NO SECONDARY FILTER TILT. FIVE CASES OF MIGRATION WERE SEEN ONE OF WHICH PREVENTED RETRIEVAL. THE REFERENCED ARTICLE CONTAINS ONE COMPLAINT AND 8 PRODUCT ISSUES INVOLVING THE OPTEASE FILER OCCURRING IN THE (B)(6). MULTIPLE ATTEMPTS HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION. HOWEVER, NO ADDITIONAL INFORMATION REGARDING PATIENT, LESION OR PROCEDURAL CHARACTERISTICS REGARDING THIS EVENT HAS BEEN PROVIDED. THE PRODUCTS WERE NOT RETURNED FOR ANALYSIS. ADDITIONALLY, AS THE STERILE LOT NUMBER WAS NOT AVAILABLE, DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. VESSEL DAMAGE/VENA CAVA INJURY IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH ALL IVC FILTER IMPLANTS AND IS LISTED IN THE IFU AS SUCH. CLINICAL STUDY DATA AND A REVIEW OF PUBLISHED LITERATURE SUPPORTS THE SAFETY AND PERFORMANCE OF VENA CAVA FILTERS WHEN USED AS INTENDED. THE SAFETY PROFILE AND TYPES/INCIDENCES OF COMPLICATIONS REPORTED IN THE LITERATURE WERE CONSISTENT WITH HAZARDS IDENTIFIED IN THE PRODUCT RISK ASSESSMENTS, WITH REPORTED COMPLAINTS SINCE PRODUCT INTRODUCTION WORLDWIDE, AND WITH KNOWN HAZARDS IDENTIFIED FOR THESE TYPES OF DEVICES. FACTORS THAT MAY HAVE INFLUENCED THE EVENT INCLUDE PATIENT, PROCEDURAL, PHARMACOLOGICAL AND LESION. HOWEVER, THERE IS NOT ENOUGH INFORMATION TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT. THE PRODUCTS WERE NOT RETURNED FOR ANALYSIS. NO CORRECTIVE OR PREVENTIVE ACTION WILL BE TAKEN, GIVEN THAT; WITH THE INFORMATION PROVIDED THE REPORTED FAILURE/EVENT DOES NOT APPEAR TO BE RELATED TO THE MANUFACTURING PROCESS.

    Additional Manufacturer Narrative · 1

    LITERATURE REVIEW: M.D. TAM, D. KLASS, M. CRAWFORD, S. GIRLING, J. SAADA, P. WILSON, J.F. (2011, SEPTEMBER 10-14). DEVICE-RELATED COMPLICATIONS AND EFFECTIVENESS OF THE OPTEASE FILTER: A RETROSPECTIVE STUDY OF 149 CASES. (B)(6). ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. THIS MDR REPORT REFLECTS THE EVENT OF MIGRATION FOR FOUR PATIENTS IN WHICH THERE IS NO PATIENT DEMOGRAPHICS OR DEVICE SPECIFICS. THIS IS ONE OF SEVEN PRODUCTS INVOLVED WITH THIS ADVERSE EVENT IN WHICH ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 9616099-2012-00703, 9616099-2012-00704, 9616099-2012-00705, 9616099-2012-00706, 9616099-2012-00707, 9616099-2012-00708 AND 9616099-2012-00709.

    Description of Event or Problem · 1

    LITERATURE EVENT DESCRIPTION: TAM ET AL DEVICE-RELATED COMPLICATIONS AND EFFECTIVENESS OF THE OPTEASE FILTER: A RETROSPECTIVE STUDY OF 149 CASES; CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGICAL SOCIETY OF EUROPE (CIRSE) 2011, REPORT THERE WAS 1 POST-FILTER PE, 9 DVTS AND 1 CAVAL OCCLUSION. THROMBUS WAS SEEN IN THE FILTER IN 12 CASES BUT THIS DID NOT PROGRESS TO OCCLUSION AND WAS ASYMPTOMATIC. THERE WERE 2 FRACTURES AND 2 CASES OF PENETRATION. THERE WAS NO SECONDARY FILTER TILT. FIVE CASES OF MIGRATION WERE SEEN ONE OF WHICH PREVENTED RETRIEVAL.

    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