BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN OPTEASE VENA CAVA FILTER

    MDR report key: 2001368 · Received February 25, 2011

    Report

    Report Number
    9610978-2011-00039
    Event Type
    Injury
    Date Received
    February 25, 2011
    Date of Event
    January 25, 2011
    Report Date
    January 31, 2011
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    DTK
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN THE PHYSICIAN WENT TO RETRIEVE THE OPTEASE VENA CAVA FILTER, TWO WEEKS POST IMPLANTATION, HE RECOGNIZED THAT THE FILTER HAD MIGRATED CAUDALLY AND LODGED IN THE LEFT COMMON ILIAC VEIN. THE RETRIEVAL HOOK WAS AGAINST THE MEDIAL ASPECT OF THE LEFT COMMON ILIAC VEIN, AND THE PHYSICIAN WAS UNABLE TO RETRIEVE THE FILTER. THE PHYSICIAN OPTED TO LEAVE THE FILTER IN THE PATIENT. THE PATIENT IS IN GOOD CONDITION. 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 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. IVC FILTER MIGRATION IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH ALL IVC FILTERS IMPLANTATION AND IS LISTED IN THE IFU AS SUCH. INTRACARDIAC MIGRATION OF IVC FILTERS IS A RARE BUT POTENTIALLY FATAL EVENT. POSSIBLE CAUSE FOR FILTER MIGRATION INCLUDES MEGA CAVA (IVC DIAMETER >28 MM), WIRE ENTRAPMENT DURING CENTRAL VENOUS CATHETER PLACEMENT, "SAIL" EFFECT 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. 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

    ADDITIONAL INFORMATION WILL BE SUBMITTED UPON 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    WHEN THE PHYSICIAN WENT TO RETRIEVE THE OPTEASE VENA CAVA FILTER, TWO WEEKS POST IMPLANTATION, HE RECOGNIZED THAT THE FILTER HAD MIGRATED CAUDALLY AND LODGED IN THE LEFT COMMON ILIAC VEIN. THE RETRIEVAL HOOK WAS AGAINST THE MEDIAL ASPECT OF THE LEFT COMMON ILIAC VEIN, AND THE PHYSICIAN WAS UNABLE TO RETRIEVE THE FILTER. THE PHYSICIAN OPTED TO LEAVE THE FILTER IN THE PATIENT. THE PATIENT IS IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN OPTEASE VENA CAVA FILTER THROMBECTOMY SYSTEMS (DTK) DTK CORDIS EUROPA, N.V. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability