BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVIVE - THROMBECTOMY DEVICE

    MDR report key: 3875350 · Received June 16, 2014

    Report

    Report Number
    1226348-2014-00123
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 27, 2014
    Manufacturer
    MICRUS ENDOVASCULAR, LLC
    Product Code
    DXE
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REV-01 DEVICE ((B)(4)) WAS USED TWO PASSES FOR LEFT M1 OCCLUSION, BUT POST-PROCEDURAL ANGIOGRAM SHOWED NO EVIDENCE OF RECANALIZATION (TICI SCORE 0). PTA AND SOLITAIRE WAS SUBSEQUENTLY USED RESULTING IN TICI 2A PARTIAL RECANALIZATION. AN EMBOLIZATION IN ICA OCCURRED DURING PTA, WHICH WAS UNDETECTABLE AT REV-01 INTRA-PROCEDURE. NO SAE IS OBSERVED AT THE MOMENT. THE DEVICE WILL BE RETURNED FOR ANALYSIS. THE REVIVE SE DEVICE WAS RETURNED UNDAMAGED. ALL SOLDER JOINTS ARE IN-TACT. ALL RADIOPAQUE MARKERS AND THE CORE PUSHER WIRE ARE INTACT. THEREFORE, THE ROOT CAUSE OF THE INEFFECTIVE TREATMENT CANNOT BE DETERMINED BY THE INSPECTION OF THE DEVICE WHICH IS FULLY INTACT. IT IS NOTED THAT ONLY TWO PASSES OF THE REVIVE WAS PERFORMED DURING THE PROCEDURE WHEN FIVE PASSES ARE ALLOWED BY THE INSTRUCTIONS FOR USE (IFU). IN ADDITION, WITHOUT THE IDENTIFICATION OR THE RETURN OF THE MICROCATHETER OR ANGIOGRAPHIC IMAGES OF DEVICE POSITIONING USED IN THE PROCEDURE, IT CANNOT BE DETERMINED IF THESE CONTRIBUTED TO THE COMPLAINT EVENT. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    REVIVE SE IS NOT DISTRIBUTED IN THE US; HOWEVER, IT IS SIMILAR TO US DISTRIBUTED REVIVE PV. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THE PRODUCT WILL BE RETURNED FOR ANALYSIS, HOWEVER IT HAS NOT BEEN RECEIVED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES: PTA (DETAILS UNKNOWN), SOLITAIRE (DETAILS UNKNOWN).

    Description of Event or Problem · 1

    REV-01 DEVICE (FRS214522/T10000) WAS USED TWO PASSES FOR LEFT M1 OCCLUSION, BUT POST-PROCEDURAL ANGIOGRAM SHOWED NO EVIDENCE OF RECANALIZATION (TICI SCORE 0). PTA AND SOLITAIRE WAS SUBSEQUENTLY USED RESULTING IN TICI 2A PARTIAL RECANALIZATION. AN EMBOLIZATION IN ICA OCCURRED DURING PTA, WHICH WAS UNDETECTABLE AT REV-01 INTRA-PROCEDURE. NO SAE IS OBSERVED AT THE MOMENT. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352721 REVIVE - THROMBECTOMY DEVICE MICRUS THROMBECTOMY DXE MICRUS ENDOVASCULAR, LLC T10000

    Patients

    Seq Age Sex Outcome Treatment
    1