BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN OPTEASE VENA CAVA FILTER

    MDR report key: 2852782 · Received November 30, 2012

    Report

    Report Number
    9616099-2012-00704
    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
    Adverse Event
    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. 5 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 UNITED KINGDOM. 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. IVC FILTER MIGRATION IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH ALL IVC FILTER IMPLANTS AND IS LISTED IN THE IFU AS SUCH. INTRACARDIAC MIGRATION OF IVC FILTERS IS A RARE BUT POTENTIALLY FATAL EVENT. POSSIBLE CAUSES FOR FILTER MIGRATION INCLUDES MEGA CAVA (IVC DIAMETER >28 MM), WIRE ENTRAPMENT DURING CENTRAL VENOUS CATHETER PLACEMENT, 'SAIL' EFFECT (CRANIAL MIGRATION) OF LARGE CLOT BURDEN WITHIN THE FILTER, MECHANICAL DEVICE FAILURE, AND OPERATOR ERROR. SOME STUDIES SUGGEST THAT STRENUOUS PHYSICAL ACTIVITY AND INCREASED INTRA-ABDOMINAL PRESSURE CAN LEAD TO THE FRACTURE AND MIGRATION OF IVC FILTERS. PHYSIOLOGIC CAUSES OF MIGRATION MAY RESULT FROM TEMPORARY DYSMORPHISM OF THE INFERIOR VENA CAVA INCLUDING BENDING, COUGHING OR VALSALVA MANEUVERS RESULTING IN DISLODGMENT OF THE FILTER. MIGRATION OF IVC FILTERS HAS BEEN DEMONSTRATED WHEN THE PRESENCE OF AN OVERBURDEN OF THROMBUS IN THE VASCULATURE OCCURS THAT EXCEEDS THE DEVICES ABILITY TO EXERT RADIAL FORCE TOWARD THE VESSEL WALLS AND MAINTAIN OPTIMAL POSITIONING AND IN PATIENTS WHO WERE IN A DEHYDRATED STATE WHEN THE FILTER WAS PLACED AND HAVE SINCE RE-HYDRATED THEREBY EXPANDING THE DIAMETER OF THE VENA CAVA. WITHOUT FILMS OF THE REPORTED EVENT THERE IS NOT ENOUGH INFORMATION TO DRAW A DEFINITIVE CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE REPORTED EVENT. THERE IS NO EVIDENCE OF MANUFACTURING OR DESIGN ISSUES THAT CONTRIBUTED TO THE EVENT.

    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 VENA CAVA OCCLUSION FOR ONE PATIENT 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 REVIEW 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. 5 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