BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM

    MDR report key: 9226388 · Received October 23, 2019

    Report

    Report Number
    2247858-2019-00070
    Event Type
    Malfunction
    Date Received
    October 23, 2019
    Date of Event
    September 24, 2019
    Report Date
    December 18, 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

    BOLTON MEDICAL IS VOLUNTARILY REPORTING A DEVICE MALFUNCTION RELATED TO THE RELAYNBS PLUS THORACIC STENT-GRAFT SYSTEM. THE RELAYNBS PLUS DEVICE IS NOT MARKETED IN THE US, HOWEVER IT IS SIMILAR TO THE RELAYPLUS THORACIC STENT-GRAFT SYSTEM APPROVED FOR SALE IN THE US IN 2012 (P110038). THE RELAYNBS PLUS RELATED EVENT OCCURRED IN GERMANY. - [MDR 2247858-2019-00070 FOLLOW-UP EVALUATION.PDF]

    Description of Event or Problem · 0

    EVENT OCCURRED WHILE PREPARING THE STENT-GRAFT - FLUSHING WITH SALINE THROUGH FLUSHPORT WAS NOT POSSIBLE / SEEMED AS LOCKED. USER, DR. (B)(6) DECIDED TO DISCARD THE GRAFT DUE TO EMBOLISM RISK. ANOTHER RELAY NBS PLUS (N4) WITH DIFFERENT DIAMETER AND LENGTH (28-M330155302290S, LOT # B170901159) WAS USED WITH SUCCESSFUL OUTCOME." PATIENT OUTCOME: "PATIENT IS WELL.".

    Additional Manufacturer Narrative · 1

    BOLTON MEDICAL IS VOLUNTARILY REPORTING A DEVICE MALFUNCTION RELATED TO THE RELAYNBS PLUS THORACIC STENT-GRAFT SYSTEM. THE RELAYNBS PLUS DEVICE IS NOT MARKETED IN THE US, HOWEVER IT IS SIMILAR TO THE RELAYPLUS THORACIC STENT-GRAFT SYSTEM APPROVED FOR SALE IN THE US IN 2012 (P110038). THE RELAYNBS PLUS RELATED EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    EVENT OCCURRED WHILE PREPARING THE STENT-GRAFT - FLUSHING WITH SALINE THROUGH FLUSHPORT WAS NOT POSSIBLE / SEEMED AS LOCKED. USER, DR. (B)(6), DECIDED TO DISCARD THE GRAFT DUE TO EMBOLISM RISK. ANOTHER RELAY NBS PLUS (N4) WITH DIFFERENT DIAMETER AND LENGTH (28-M330155302290S, LOT # B170901159) WAS USED WITH SUCCESSFUL OUTCOME." PATIENT OUTCOME: "PATIENT IS WELL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1025256 RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM STENT, ENDOVASCUALR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. B190603008

    Patients

    Seq Age Sex Outcome Treatment
    1 00 YR