BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM

    MDR report key: 7323741 · Received March 8, 2018

    Report

    Report Number
    2247858-2018-00050
    Event Type
    Injury
    Date Received
    March 8, 2018
    Date of Event
    February 15, 2016
    Report Date
    March 8, 2018
    Manufacturer
    BOLTON MEDICAL, INC.
    Product Code
    MIH
    PMA / PMN Number
    P110038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    "DURING AN INTERNAL AUDIT, IT WAS DETERMINED THAT COMPLAINTS FOR SIMILAR DEVICES, AND DEVICE MALFUNCTIONS THAT HAVE THE POTENTIAL TO HARM THE PATIENT IF THEY WERE TO RECUR, WERE NOT REPORTED AS PER FDA GUIDANCE. AFTER RETROSPECTIVE REVIEW, THIS EVENT IS DETERMINED TO BE MDR REPORTABLE." "BOLTON MEDICAL IS VOLUNTARILY REPORTING A DEVICE MALFUNCTION RELATED TO THE RELAY THORACIC STENT GRAFT WITH PLUS DELIVERY SYSTEM (RELAY 85). THE RELAY 85 SYSTEM 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).

    Description of Event or Problem · 1

    IT SEEMS A TYPE IV OR III ENDOLEAK OCCURS AT THE MIDDLE OF STENT-GRAFT. MR.(B)(4) (OF THE DISTRIBUTOR) SAID IT HAPPENED SEVERAL TIMES WHEN USING THE LATEST BATCH OF PRODUCT. SO FAR PATIENT IS OK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168911 RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM STENT, ENDOVASCULAR GRAFT, AORTIC, MIH BOLTON MEDICAL, INC. B150820093

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other