BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM

    MDR report key: 9571211 · Received January 9, 2020

    Report

    Report Number
    2247858-2020-00003
    Event Type
    Malfunction
    Date Received
    January 9, 2020
    Date of Event
    December 17, 2019
    Report Date
    February 14, 2020
    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

    CORRECTION: BOLTON MEDICAL INADVERTENTLY REPORTED THIS COMPLAINT UNDER MDR 2247858-2020-00003. HOWEVER, THIS COMPLAINT IS NOT REPORTABLE SINCE IT IS RELATED TO A CUSTOM-MADE RELAYNBS PLUS CUSTOM MADE DEVICE. BASED ON THE NATURE OF THIS COMPLAINT, THE SUBJECT DEVICE IS NOT CONSIDERED SIMILAR TO THE US APPROVED RELAY PLUS PRODUCT FAMILY (P110038).

    Description of Event or Problem · 0

    "WHEN FLUSHING THE STENT-GRAFT PART OF THE DS WE EXPERIENCED THAT IT WAS NOT POSSIBLE TO BRING ANY SALINE INTO THE DS. WHEN IN POSITION NUMBER 1, WE TRIED TO ADVANCE THE SG A COUPLE OF MILLIMETERS TO SEE IF THIS WILL CHANCE THE SITUATION WITH NEGATIVE OUTCOME. SO WE STOPPED IMPLANTATION AT THIS POINT." PATIENT OUTCOME: "PATIENT WAS UNDER ANESTHESIA AND BOTH CAROTID ARTERIES AS WELL AS THE FEMORAL ARTERIES WERE ALREADY EXPOSED WHEN WE STOPPED THE IMPLANTATION."

    Additional Manufacturer Narrative · 1

    BOLTON MEDICAL IS VOLUNTARILY REPORTING A DEVICE MALFUNCTION RELATED TO THE RELAYNBS PLUS CUSTOM MADE DEVICE. THE RELAYNBS PLUS 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 RELAYNBS PLUS CUSTOM MADE DEVICE RELATED EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    "WHEN FLUSHING THE STENT-GRAFT PART OF THE DS WE EXPERIENCED THAT IT WAS NOT POSSIBLE TO BRING ANY SALINE INTO THE DS. WHEN IN POSITION NUMBER 1, WE TRIED TO ADVANCE THE SG A COUPLE OF MILLIMETERS TO SEE IF THIS WILL CHANCE THE SITUATION WITH NEGATIVE OUTCOME. SO WE STOPPED IMPLANTATION AT THIS POINT." PATIENT OUTCOME: "PATIENT WAS UNDER ANESTHESIA AND BOTH CAROTID ARTERIES AS WELL AS THE FEMORAL ARTERIES WERE ALREADY EXPOSED WHEN WE STOPPED THE IMPLANTATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36085 RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM STENT, ENDOVASCUALR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. 1911010060

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR