BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM

    MDR report key: 10437466 · Received August 21, 2020

    Report

    Report Number
    2247858-2020-00038
    Event Type
    Malfunction
    Date Received
    August 21, 2020
    Date of Event
    July 30, 2020
    Report Date
    September 3, 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

    BOLTON MEDICAL IS VOLUNTARILY REPORTING A DEVICE MALFUNCTION RELATED TO THE RELAY CUSTOM MADE DEVICE. THE RELAY 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 RELAY CUSTOM MADE RELATED EVENT OCCURRED IN GERMANY.

    Description of Event or Problem · 0

    "RELAY CM 2386 WAS PLACED AT THE POSITION. CONTROL-CT SHOWED INFOLDING OF THE FIRST 30MM. ENDOLEAK. EMAIL RECEIVED ON AUGUST 5, 2020 FROM THOMAS ROEDING: HI MANUEL, SPOKEN WITH THEM TODAY. PATIENT FINE SO FAR. THEY WILL BALLOON THE AREA UNDER CIRCULATORY ARREST END OF (B)(6)." PATIENT OUTCOME: "PATIENT STATUS AFTER THE PROCEDURE WAS FINE."

    Additional Manufacturer Narrative · 1

    BOLTON MEDICAL IS VOLUNTARILY REPORTING A DEVICE MALFUNCTION RELATED TO THE 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).

    Description of Event or Problem · 1

    "RELAY CM 2386 WAS PLACED AT THE POSITION. CONTROL-CT SHOWED INFOLDING OF THE FIRST 30MM ENDOLEAK. EMAIL RECEIVED ON (B)(6) 2020 FROM (B)(6): HI (B)(6), SPOKEN WITH THEM TODAY. PATIENT FINE SO FAR. THEY WILL BALLOON THE AREA UNDER CIRCULATORY ARREST END OF (B)(6)/BEGINNING OF (B)(6)." PATIENT OUTCOME: "PATIENT STATUS AFTER THE PROCEDURE WAS FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    904764 RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM STENT, ENDOVASCUALR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. 2005220079

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR