BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM

    MDR report key: 8942073 · Received August 28, 2019

    Report

    Report Number
    2247858-2019-00061
    Event Type
    Malfunction
    Date Received
    August 28, 2019
    Date of Event
    July 31, 2019
    Report Date
    October 15, 2019
    Manufacturer
    BOLTON MEDICAL, INC.
    Product Code
    MIH
    PMA / PMN Number
    P110038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    - ATTACHMENT: [MDR 2247858-2019-00061 FOLLOW-UP EVALUATION.PDF].

    Description of Event or Problem · 0

    32X100 RELAY PLUS DEVICE PASSED UP THRU THE RIGHT FEMORAL ACCESS VESSELS IN STAGE ONE. THE ORANGE RETAINER WAS REMOVED AND AN ATTEMPT TO MOVE THE GREY HANDY FORWARD TO THE TARGET PLZ WAS MET WITH SEVERE RESISTANCE THAT REQUIRED BRUTE FORCE TO OVERCOME AND DELIVER. AT STAGE 2 THE SAME AMOUNT OF RESISTANCE WAS MET WHEN THE OPERATOR ATTEMPTED TO DEPLOY THE DEVICE. THE 32X100 EVENTUALLY WAS DEPLOYED SUCCESSFULLY AND THE PATIENT'S CONDITION WAS SUCCESSFULLY TREATED WITH NO CLINICAL SEQUALA OR ADVERSE EVENTS." PATIENT OUTCOME: "PATIENT HAD A SUCCESSFUL CLINICAL TREATMENT AND ACCURATE PLACEMENT OF A 32X100 RELAY PLUS ENDOGRAFT WITH NO ADVERSE EVENTS OR CLINICAL SEQUALA."

    Description of Event or Problem · 1

    32X100 RELAY PLUS DEVICE PASSED UP THRU THE RIGHT FEMORAL ACCESS VESSELS IN STAGE ONE. THE ORANGE RETAINER WAS REMOVED AND AN ATTEMPT TO MOVE THE GREY HANDY FORWARD TO THE TARGET PLZ WAS MET WITH SEVERE RESISTANCE THAT REQUIRED BRUTE FORCE TO OVERCOME AND DELIVER. AT STAGE 2 THE SAME AMOUNT OF RESISTANCE WAS MET WHEN THE OPERATOR ATTEMPTED TO DEPLOY THE DEVICE. THE 32X100 EVENTUALLY WAS DEPLOYED SUCCESSFULLY AND THE PATIENT'S CONDITION WAS SUCCESSFULLY TREATED WITH NO CLINICAL SEQUELA OR ADVERSE EVENTS." PATIENT OUTCOME: "PATIENT HAD A SUCCESSFUL CLINICAL TREATMENT AND ACCURATE PLACEMENT OF A 32X100 RELAY PLUS ENDOGRAFT WITH NO ADVERSE EVENTS OR CLINICAL SEQUELA."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732318 RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM STENT, ENDOVASCUALR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. 171228218

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR