BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MISAGO RX SELF-EXPANDING PERIPHERAL STENT

    MDR report key: 5916969 · Received August 31, 2016

    Report

    Report Number
    9681834-2016-00208
    Event Type
    Injury
    Date Received
    August 31, 2016
    Date of Event
    August 2, 2016
    Report Date
    August 31, 2016
    Manufacturer
    TERUMO CORPORATION, ASHITAKA
    Product Code
    NIP
    UDI-DI
    04987350722263
    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

    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 PRODUCTION LOT NUMBER WAS NOT PROVIDED BY THE USER FACILITY, WHICH PREVENTED A MEANINGFUL REVIEW OF PRODUCTION AND COMPLAINT RECORDS. THE USER FACILITY REPORTED THAT TWO STENTS WERE PLACED IN THE PATIENT, ALSO SEE MDR 9681834-2016-00211. 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 THROMBOSED STENTS AFTER THEY WERE PLACED IN THE PATIENT. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: THE DOCTOR USED TWO 7X150 MISAGO STENTS; ANGIOGRAPHIC RESULT AFTER STENT PLACEMENT SHOWED THE STENTS TO BE THROMBOSED; THE PATIENT WAS DRIPPED WITH TPA OVERNIGHT AND TREATED SEVERAL DAYS LATER WITH A KEESLER AFB; THE PATIENT HAD SURGICAL INTERVENTION FOR ''COMPARTMENT SYNDROME'' RELATED TO THE ISCHEMIA OF THE LEG WHILE MAJOR ARTERIES WERE THROMBOSED; AND A TECH AT KEESLER REPORTED THAT UNDER ANGIOGRAPHY THE STENTS HAD RESTENOSED AT THE EDGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570282 MISAGO RX SELF-EXPANDING PERIPHERAL STENT STENT NIP TERUMO CORPORATION, ASHITAKA NA UNK 04987350722263

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 7X150 MISAGO STENT| 7X150 MISAGO STENT