BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN OPTEASE VENA CAVA FILTER

    MDR report key: 1338806 · Received March 9, 2009

    Report

    Report Number
    9610978-2009-00052
    Event Type
    Death
    Date Received
    March 9, 2009
    Date of Event
    February 9, 2009
    Report Date
    February 21, 2009
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    DTK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO STERILE LOT NUMBER INFORMATION AVAILABLE THUS NO DHR COULD BE PERFORMED. THROMBO-EMBOLIC EVENTS ARE A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH IVC FILTER IMPLANTATION AND ARE LISTED IN THE IFU AS SUCH. THIS INVESTIGATION WAS LIMITED BY THE LACK OF PRODUCT RETURN AND NO STERILE LOT NUMBER INFORMATION. IN THIS CASE, THE PATIENT HAD A KNOWN HISTORY OF DVT WITH PE, AND THE DEVICE WAS UTILIZED WHILE THE PATIENT COULD NOT BE ON AN ANTICOAGULATION MEDICATION REGIMEN FOR BACK SURGERY. REVIEW OF THE LIMITED INFORMATION SUGGESTS THAT PATIENT AND MEDICATION REGIMEN FACTORS HAVE CONTRIBUTED TO THE UNFORTUNATE EVENT.

    Description of Event or Problem · 1

    THE COMPLAINT RECEIVED STATES THAT AFTER OPTEASE IVC FILTER IMPLANTATION, THAT PATIENT EXPIRED FROM A THROMBO-EMBOLIC EVENT. THE PATIENT WAS A FEMALE WITH MEDICAL HISTORY INCLUDING DVT (DEEP VEIN THROMBOSIS) AND PE (PULMONARY EMBOLISM). THE PATIENT WAS SCHEDULED FOR BACK SURGERY, AND IVC FILET IMPLANTATION WAS DONE PRIOR TO THE BACK SURGERY. ALL MEDICATIONS WERE STOPPED FOR THE ANTICIPATED BACK SURGERY AND THE IVC FILTER WAS PLACED PROPHYLACTICALLY. THE BACK SURGERY WAS COMPLETED WITHOUT REPORT OF COMPLICATIONS. SEVERAL DAYS FOLLOWING THE BACK SURGERY, THE PATIENT REPORTED WITH COMPLICATIONS AND DIED FIVE DAYS AFTER THE COMPLICATIONS, FROM A THROMBO-EMBOLIC EVENT. PER THE PHYSICIAN, "AN AUTOPSY WAS NOT PERFORMED AND THE CAUSE OF DEATH WAS PROBABLY DUE TO THROMBOSIS THROUGHOUT THE VENOUS SYSTEM." THE FILTER REMAINS IMPLANTED THUS IS UNAVAILABLE FOR ANALYSIS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death