BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITANIUM GREENFIELD VENA CAVA FILTER WITH 12F/4.0MM INTRODUCER SYSTEM

    MDR report key: 2071127 · Received April 27, 2011

    Report

    Report Number
    2134265-2011-01542
    Event Type
    Injury
    Date Received
    April 27, 2011
    Date of Event
    March 4, 2011
    Report Date
    March 30, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    DTK
    PMA / PMN Number
    K901659
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST A PERIPHERAL FILTER TREATMENT PROCEDURE, THROMBUS WAS IDENTIFIED. A TITANIUM GREENFIELD VENA CAVA FILTER WAS IMPLANTED IN THE RIGHT JUGULAR ON AN UNKNOWN DATE. POST PROCEDURE, THE PATIENT REPORTED DYSPNEA AND THROMBUS. SHE REPORTED THAT EVERY TIME SHE HAS SURGERY, SHE GETS A BLOOD CLOT IN THE LEFT LEG AFTER APPROXIMATELY 6 WEEKS. THE PATIENT UNDERWENT ORAL SURGERY FOR TEETH EXTRACTIONS ON AN UNSPECIFIED DATE. SHE STOPPED TAKING FRAGMIN FOR 48 HOURS PRIOR TO SURGERY, WAS PUT ON HEPARIN WHILE IN THE HOSPITAL AND AFTER SURGERY, WAS PUT BACK ON FRAGMIN. SHE WAS RELEASED ON (B)(6), 2011. THE PATIENT WENT TO THE ER ON (B)(6), 2011 FOR AN UNSPECIFIED REASON. SHE RETURNED TO THE ER AGAIN ON (B)(6), 2011 WITH REPORTED DEHYDRATION AND WAS RELEASED ON (B)(6), 2011. ON (B)(6), 2011 THE PATIENT WENT TO THE ER AND THROMBUS WAS IDENTIFIED IN AN UNSPECIFIED LOCATION. THE PATIENT WAS ON HEPARIN. THE PATIENT WAS RELEASED ON (B)(6), 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TITANIUM GREENFIELD VENA CAVA FILTER WITH 12F/4.0MM INTRODUCER SYSTEM FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK BOSTON SCIENTIFIC - CORK M001503000 4662351

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Other