BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM

    MDR report key: 11113613 · Received January 4, 2021

    Report

    Report Number
    2247858-2021-00004
    Event Type
    Injury
    Date Received
    January 4, 2021
    Date of Event
    November 10, 2020
    Report Date
    March 23, 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 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 RELAY THORACIC STENT GRAFT WITH PLUS DELIVERY SYSTEM APPROVED FOR SALE IN THE US IN 2012 (P110038). THE RELAYNBS PLUS RELATED EVENT OCCURED IN GERMANY.

    Description of Event or Problem · 0

    ENDOLEAK TYPE IA WE HAVE A NOTE THAT SURGEON DESCRIBED AE AS UNKNOWN CAUSE (UNDETERMINED). PATIENT WILL GET A NEW ANGIOGRAPHY AROUND 6 TILL 8 WEEKS. THEREFORE, WE HAVE TO ACCEPT UNKNOWN CAUSE AT THIS TIME. PATIENT OUTCOME - "PATIENT IS IN A GOOD CONDITION."

    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 RELAY THORACIC STENT GRAFT WITH PLUS DELIVERY SYSTEM APPROVED FOR SALE IN THE US IN 2012 (P110038). THE RELAYNBS PLUS RELATED EVENT OCCURED IN (B)(6).

    Description of Event or Problem · 1

    ENDOLEAK TYPE IA. WE HAVE A NOTE THAT SURGEON DESCRIBED AE AS UNKNOWN CAUSE (UNDETERMINED). PATIENT WILL GET A NEW ANGIOGRAPHY AROUND 6 TILL 8 WEEKS. THEREFORE, WE HAVE TO ACCEPT UNKNOWN CAUSE AT THIS TIME. PATIENT OUTCOME - "ONGOING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3296 RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM STENT, ENDOVASCULAR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. B180510204

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR Other