BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SE STENT

    MDR report key: 7808893 · Received August 23, 2018

    Report

    Report Number
    2183870-2018-00419
    Event Type
    Injury
    Date Received
    August 23, 2018
    Date of Event
    January 1, 2003
    Report Date
    August 23, 2018
    Manufacturer
    COVIDIEN
    Product Code
    NIO
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    ESTIMATION, PATIENT REPORTED TO BE IN THEIR EARLY 50S AT TIME OF EVENT. WEIGHT REPORTED (B)(6). DATE OF EVENT: APPROXIMATELY 2003. IMPLANT DATE: APPROXIMATELY 1998. PMA / 510(K) #: PRODUCT IN UNKNOWN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PATIENT HAD AN UNKNOWN APPROXIMATELY 8-INCH STENT IMPLANTED APPROXIMATELY 20 YEARS AGO TO ADDRESS CIRCULATION ISSUES. PATIENT REPORT EDLY LEFT CONDITION UNTIL IT WAS SEVERE. PATIENT HAD DEVICE IMPLANTED BEHIND KNEE ON RIGHT LEG. FIVE TO SEVEN YEARS POST IMPLANT OF THE STENT THE PATIENT IS REPORTED TO HAVE EXPERIENCED COMPLICATIONS. IT IS REPORTED THAT THE STENT TWISTED IN HIS LEG AND CUT OFF CIRCULATION. ATTEMPTS WERE MADE TO REMOVE THE STENT, BUT IT ENDED UP BREAKING UP. THE STENT WAS REMOVED. IT WAS REPORTED THAT THE VEIN HAD RECANALIZED. PERIPHERY VEINS BECOME WIDER AND STRONGER BUT DID NOT EVENLY PUMP LEADING TO GANGRENE. THE PATIENT DECLINED AMPUTATION. IT WAS REPORTED THAT THE PATIENT DIED APPROXIMATELY TEN YEARS POST REMOVAL OF THE STENT. THE DEVICE IS NOT SUSPECTED TO HCE CONTRIBUTED TO THE PATIENT DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652767 UNKNOWN SE STENT NIO COVIDIEN UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention