BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRAPEASE FILTER

    MDR report key: 1940715 · Received December 29, 2010

    Report

    Report Number
    9610978-2010-00265
    Event Type
    Injury
    Date Received
    December 29, 2010
    Report Date
    December 6, 2010
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    DTK
    PMA / PMN Number
    K020316
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THE DEVICE WAS IMPLANTED AND EXPLANTED IN (B)(6) 2007. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    PER THE LAWYER FOR THE PATIENT, ON (B)(6) 2007, A TRAPEASE VENA CAVA FILTER WAS PLACED IN THE PATIENT'S VENA CAVA FOR UNKNOWN REASONS. ON (B)(6) 2007, PATIENT WAS HOSPITALIZED AS A RESULT OF THE FILTER MIGRATING TO HIS HEART. THE FILTER WAS REMOVED AS EMERGENCY SURGERY AND FURTHER TREATMENT WAS UNKNOWN. EVENT RESULTED IN "SUSTAINED DAMAGE TO THE PATIENT'S HEART" CAUSING THE PATIENT "CHRONIC FATIGUE." NO FURTHER INFORMATION WAS PROVIDED AS IT WAS UNKNOWN. THE PATIENT MEDICAL HISTORY INCLUDES HERNIA OPERATION AND STROKE. 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 ROOT CAUSE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. 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. SINCE THE PRODUCT, ADDITIONAL INFORMATION OR FILMS OF THE PROCEDURE WILL NOT BE RETURNED, THERE IS NOT ENOUGH INFORMATION TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT.

    Description of Event or Problem · 1

    A LAWYER CALLED ON BEHALF OF A PATIENT REQUESTING MEDICAL INFORMATION AND ADDITIONALLY REPORTED AN ADVERSE EVENT. ON (B)(6) 2007, A TRAPEASE VENA CAVA FILTER WAS PLACED IN THE PATIENT'S VENA CAVA FOR UNKNOWN REASONS. ON(B)(6) 2007, PATIENT WAS HOSPITALIZED AS A RESULT OF THE FILTER MIGRATING TO HIS HEART. THE FILTER WAS REMOVED AS EMERGENCY SURGERY AND FURTHER TREATMENT IF ANY WAS UNKNOWN. EVENT RESULTED IN "SUSTAINED DAMAGE TO THE PATIENT'S HEART" CAUSING THE PATIENT "CHRONIC FATIGUE." NO FURTHER INFORMATION WAS PROVIDED AS IT WAS UNKNOWN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention