BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM

    MDR report key: 11415556 · Received March 4, 2021

    Report

    Report Number
    2247858-2021-00022
    Event Type
    Malfunction
    Date Received
    March 4, 2021
    Date of Event
    November 12, 2020
    Report Date
    June 2, 2021
    Manufacturer
    BOLTON MEDICAL, INC.
    Product Code
    MIH
    PMA / PMN Number
    P110038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BOLTON MEDICAL IS VOLUNTARILY REPORTING AN EVENT RELATED TO A RELAYPLUS CUSTOM-MADE DEVICE. THE RELAYPLUS CUSTOM-MADE DEVICE IS NOT MARKETED IN THE US, HOWEVER IT IS SIMILAR TO THE RELAY THORACIC STENT GRAFT WITH PLUS DELIVERY SYSTEM APPROVED FOR SALE IN THE US IN 2012 (P110038). THE RELAYPLUS CUSTOM-MADE RELATED EVENT OCCURRED IN GERMANY.

    Description of Event or Problem · 0

    "DUE TO THE SEVERE KINK IN THE DESCENDING AORTA IT WAS NOT POSSIBLE TO ADVANCE THE DELIVERY SYSTEM TO THE INTENDED LANDING ZONE. THEN THE SURGEON TRIED TO TREAT THE PATIENT WITH A COMPETITOR GRAFT BUT WITH THE SAME RESULT." PATIENT OUTCOME - "THE PATIENT WAS DISCHARGED THEN WITHOUT TREATMENT."

    Additional Manufacturer Narrative · 1

    BOLTON MEDICAL IS VOLUNTARILY REPORTING AN EVENT RELATED TO A RELAYPLUS CUSTOM-MADE DEVICE. THE RELAYPLUS CUSTOM-MADE DEVICE IS NOT MARKETED IN THE US, HOWEVER IT IS SIMILAR TO THE RELAY THORACIC STENT GRAFT WITH PLUS DELIVERY SYSTEM APPROVED FOR SALE IN THE US IN 2012 (P110038). THE RELAYPLUS CUSTOM-MADE RELATED EVENT OCCURRED IN (B)(6). THIS EVENT WAS NOT ORIGINALLY REPORTED SINCE THE ISSUE WAS ANATOMY DRIVEN AND NOT DEVICE RELATED. AFTER FURTHER INTERNAL REVIEW, IT WAS DETERMINED THAT IT SHOULD BE A REPORTABLE EVENT AND IS THEREFORE BEING SUBMITTED.

    Description of Event or Problem · 1

    "DUE TO THE SEVERE KINK IN THE DESCENDING AORTA IT WAS NOT POSSIBLE TO ADVANCE THE DELIVERY SYSTEM TO THE INTENDED LANDING ZONE. THEN THE SURGEON TRIED TO TREAT THE PATIENT WITH A COMPETITOR GRAFT BUT WITH THE SAME RESULT." PATIENT OUTCOME - "THE PATIENT WAS DISCHARGED THEN WITHOUT TREATMENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311683 RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM STENT, ENDOVASCULAR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. 2010070374

    Patients

    Seq Age Sex Outcome Treatment
    1 00 YR Other