BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MISAGO RX SELF-EXPANDING PERIPHERAL STENT

    MDR report key: 5916978 · Received August 31, 2016

    Report

    Report Number
    9681834-2016-00213
    Event Type
    Injury
    Date Received
    August 31, 2016
    Report Date
    August 31, 2016
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    NIP
    PMA / PMN Number
    P140002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    D4 - THE PRODUCT CODE AND LOT NUMBER IS UNKNOWN, THEREFORE THE UDI NUBMER COULD NOT BE PROVIDED. THE ACTUAL DEVICE WAS NOT RETURNED TO THE MANUFACTURING FACILITY FOR EVALUATION. THEREFORE, THE INVESTIGATION WAS LIMITED TO THE INFORMATION PROVIDED BY THE USER FACILITY. THE PRODUCT CODE/LOT NUMBER COMBINATION WAS NOT PROVIDED BY THE USER FACILITY, WHICH PREVENTED A MEANINGFUL REVIEW OF PRODUCTION AND COMPLAINT RECORDS. THERE IS NO EVIDENCE THAT THIS EVENT WAS RELATED TO A DEVICE DEFECT OR MALFUNCTION. A CAUSE-AND-EFFECT RELATIONSHIP BETWEEN THIS COMPLAINT AND THE ACTUAL SAMPLE CANNOT BE DEFINITELY DETERMINED BASED ON THE AVAILABLE INFORMATION. THE POTENTIAL FOR SUCH AN EVENT IS ADDRESSED IN THE INSTRUCTION-FOR-USE (IFU) WITH STATEMENTS SUCH AS THE FOLLOWING: "PATIENTS FOR A PERIPHERAL INTERVENTION SHOULD BE SELECTED CAREFULLY. OPERATORS SHOULD BEAR IN MIND THAT COMPLICATIONS, INCLUDING (BUT NOT LIMITED TO) SUBACUTE THROMBOSIS, VESSEL COMPLICATION AND HEMORRHAGIC COMPLICATIONS, MAY RESULT FROM PERIPHERAL INTERVENTION". TERUMO MEDICAL PRODUCTS (TMP) (IMPORTER) REGISTRATION NO. 2243441 IS SUBMITTING THIS REPORT ON BEHALF OF ASHITAKA FACTORY OF TERUMO CORPORATION (MANUFACTURER) REGISTRATION NO. 9681834. EXEMPTION NUMBER E2015022. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE AT THE MANUFACTURING FACILITY FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP. H3 OTHER TEXT : ACTUAL DEVICE NOT AVAILABLE

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THERE WAS A THROMBOTIC EVENT AND THE PATIENT WAS RE-STENTED AT ANOTHER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569994 MISAGO RX SELF-EXPANDING PERIPHERAL STENT STENT NIP TERUMO CORPORATION, ASHITAKA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other