BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRAPEASE FILTER

    MDR report key: 2772371 · Received October 4, 2012

    Report

    Report Number
    9616099-2012-00550
    Event Type
    Death
    Date Received
    October 4, 2012
    Date of Event
    June 1, 2006
    Report Date
    September 13, 2012
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DQO
    PMA / PMN Number
    K020316
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CORDIS HAS BEEN ADVISED THAT THE STUDY IS CLOSED AND THAT THEY CANNOT PROVIDE ANY DATA WE REQUESTED. THERE IS NO ADDITIONAL INFORMATION REGARDING PATIENT, LESION OR PROCEDURAL CHARACTERISTICS REGARDING THIS EVENT. THE PRODUCTS WERE NOT RETURNED FOR ANALYSIS. ADDITIONALLY, AS THE STERILE LOT NUMBERS WERE NOT AVAILABLE, DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. 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. WITH THE LIMITED AMOUNT OF INFORMATION AVAILABLE AND WITHOUT THE RETURN OF THE PRODUCT OR FILMS OF THE PROCEDURE IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT. FACTORS THAT MAY HAVE INFLUENCED THE EVENT INCLUDE PATIENT, PROCEDURAL, PHARMACOLOGICAL AND VESSEL. PLEASE NOTE THAT THIS ARTICLE IS FROM A LITERATURE SOURCE: KALVA ET AL. TRAPEASE VENA CAVA FILTER: EXPERIENCE IN 751 PATIENTS. JOURNAL OF ENDOVASCULAR THERAPY (2006) 13: 365-372. THIS REPORT REPRESENTS NOTIFICATION OF 1 INCIDENT OF DEATH ATTRIBUTED TO PULMONARY EMBOLISM NOTED IN THE ARTICLE. PLEASE NOTE THAT THE CATALOG AND LOT NUMBERS OF THE TRAPEASE DEVICE ARE NOT KNOWN AND ARE NOT AVAILABLE. THE CATALOG NUMBER RELATES TO AN UNKNOWN TRAPEASE DEVICE. THIS IS ONE OF 6 REPORTS ASSOCIATED WITH THE REPORTED EVENTS THAT WERE SUBMITTED UNDER MANUFACTURING REPORT NUMBERS9616099-2012-00550, 9616099-2012-00551, 9616099-2012-00553, 9616099-2012-00555, 9616099-2012-00556 AND 9616099-2012-00557.

    Description of Event or Problem · 1

    KALVA ET AL. TRAPEASE VENA CAVA FILTER: EXPERIENCE IN 751 PATIENTS. JOURNAL OF ENDOVASCULAR THERAPY (2006) 13: 365-372; REPORT IN THE RESULTS THAT AT THE 295-DAY CLINICAL FOLLOW-UP (RANGE 1-1677), 55 (7.5%) PATIENTS DEVELOPED SYMPTOMS OF PE, AND 1 (0.1%) DEATH WAS ATTRIBUTED TO PE. CHEST CT PERFORMED FOR VARIOUS CLINICAL INDICATIONS IN 219 PATIENTS AT A MEAN 192 DAYS (RANGE 1-1346) SHOWED PE IN 15 (6.8%) PATIENTS; 10 WERE SYMPTOMATIC AND 5 ASYMPTOMATIC, BUT THERE WERE NO FATALITIES. FOLLOW-UP ABDOMINAL CT (B)(4) AT A MEAN 189 DAYS (RANGE 1-1415) SHOWED FRACTURE OF FILTER COMPONENTS IN 8 (3.0%), THROMBUS WITHIN THE FILTER IN 68 (25.2%), THROMBUS EXTENDING BEYOND THE FILTER IN 4 (1.5%) AND NEAR TOTAL CAVAL OCCLUSION IN 2 (.07%).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death