BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRAPEASE FILTER

    MDR report key: 3150048 · Received June 6, 2013

    Report

    Report Number
    9616099-2013-00349
    Event Type
    Injury
    Date Received
    June 6, 2013
    Date of Event
    April 1, 2005
    Report Date
    May 12, 2013
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DQO
    PMA / PMN Number
    K020316
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE ARTICLE: LIU, W AND ET AL. (2005, APRIL, 2). THE MID-TERM EFFICACY AND SAFETY OF A PERMANENT NITINOL IVC FILTER (TRAPEASE). KOREAN JOURNAL OF RADIOLOGY, 6, 110-116. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: LIU ET AL THE MID-TERM EFFICACY AND SAFETY OF A PERMANENT NITINOL IVC FILTER (TRAPEASE), KOREAN J RADIOL. 2005 APR-JUN;6(2):110-6; REPORTS A CASE OF SYMPTOMATIC IVC OBSTRUCTION BY A TRAPEASE FILTER THROMBOSIS DURING HOSPITALIZATION. THIS PATIENT HAD UNDERLYING BEHCET DISEASE AND DEEP VEIN THROMBOSIS (DVT) WITH FREE-FLOATING IVC THROMBOSIS. LOWER LEG SWELLING WAS AGGRAVATED AFTER FILTER PLACEMENT. AT ONE-WEEK FOLLOW-UP BY CONTRAST ENHANCED ABDOMINAL CT SCAN SHOWED TOTAL AN IVC OBSTRUCTION UNDER THE FILTER LEVEL. THIS IVC OBSTRUCTION WAS SUCCESSFULLY TREATED WITH INTRAVENOUS UROKINASE AND HEPARIN. THROMBUS WAS STILL DETECTED IN THE ONE-MONTH FOLLOW-UP CT . THIS PATIENT UNDERWENT ANTICOAGULATION THERAPY DURING THE ENTIRE FOLLOW-UP PERIOD. THE THROMBUS WAS FOUND TO BE COMPLETELY RESOLVED IN THE 6- AND 12-MONTH FOLLOW-UP INTERVALS USING CONTRAST ABDOMINAL CTS. THE PRODUCT REMAINED IMPLANTED IN THE PATIENT AND IS THUS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED WITHOUT A LOT NUMBER. THE IFU LISTS FILTER OBSTRUCTION AS A POSSIBLE PROCEDURE COMPLICATION POST IMPLANTATION. 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¿S FACTORS (BEHCET DISEASE, DVT) AND PHARMACOLOGICAL FACTORS. WITHOUT A LOT NUMBER TO CONDUCT A DHR REVIEW, IT IS NOT POSSIBLE TO DETERMINE IF THE REPORTED FAILURE COULD BE RELATED TO THE MANUFACTURING PROCESS. HOWEVER, THE INFORMATION PROVIDED DOES NOT SUGGEST THAT THE REPORTED EVENT COULD BE RELATED TO THE MANUFACTURING PROCESS. THEREFORE NO CORRECTIVE AND PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    AS NOTED IN THE FOLLOWING LITERATURE ARTICLE, ONE PATIENT CASE OF SYMPTOMATIC IVC OBSTRUCTION BY A TRAPEASE FILTER THROMBOSIS DURING HOSPITALIZATION. THIS PATIENT HAD UNDERLYING BEHCET DISEASE AND DEEP VEIN THROMBOSIS (DVT) WITH FREE-FLOATING IVC THROMBOSIS. LOWER LEG SWELLING WAS AGGRAVATED AFTER FILTER PLACEMENT. AT ONE-WEEK FOLLOW-UP BY CONTRAST ENHANCED ABDOMINAL CT SCAN SHOWED TOTAL AN IVC OBSTRUCTION UNDER THE FILTER LEVEL. THIS IVC OBSTRUCTION WAS SUCCESSFULLY TREATED WITH INTRAVENOUS UROKINASE AND HEPARIN. THROMBUS WAS STILL DETECTED IN THE ONE-MONTH FOLLOW-UP CT . THIS PATIENT UNDERWENT ANTICOAGULATION THERAPY DURING THE ENTIRE FOLLOW-UP PERIOD. THE THROMBUS WAS FOUND TO BE COMPLETELY RESOLVED IN THE 6 AND 12-MONTH FOLLOW-UP INTERVALS USING CONTRAST ABDOMINAL CTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251012 TRAPEASE FILTER THROMBECTOMY SYSTEMS (DQO) DQO CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R