BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM

    MDR report key: 8418165 · Received March 13, 2019

    Report

    Report Number
    2247858-2019-00011
    Event Type
    Injury
    Date Received
    March 13, 2019
    Date of Event
    January 8, 2019
    Report Date
    May 16, 2019
    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 · 0

    THIS COMPLAINT WAS INVOLVED WITH THREE DEVICES. DEVICE 1 IS BEING REPORTED UNDER MDR 2247858-2019-00010. DEVICE 2 IS BEING REPORTED UNDER THE INITIAL REPORT. DEVICE 3 IS BEING REPORTED UNDER MDR 2247858-2019-00012. BOLTON MEDICAL IS VOLUNTARILY REPORTING A DEVICE MALFUNCTION RELATED TO THE TREO ABDOMINAL STENT-GRAFT SYSTEM. THE TREO ABDOMINAL STENT-GRAFT 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). THE TREO ABDOMINAL STENT-GRAFT SYSTEM RELATED EVENT OCCURRED IN BELGIUM. ATTACHMENT: [(INITIAL REPORT) - DEVICE 2 FOLLOW-UP EVALUATION.PDF].

    Description of Event or Problem · 0

    "STENOSIS IN STENT ILIAC LEFT. SEVERITY: MODERATE . RELATEDNESS: RELATED TO DEVICE AND NOT RELATED TO PROCEDURE". PATIENT OUTCOME: "STENT + BALLOON. OUTCOME: RECOVERED. EVENT STOP DATE: (B)(6) 2019".

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT WAS INVOLVED WITH THREE DEVICES. DEVICE 1 IS BEING REPORTED UNDER MDR 2247858-2019-00010. DEVICE 2 IS BEING REPORTED UNDER MDR 2247858-2019-00011. DEVICE 3 IS BEING REPORTED UNDER MDR 2247858-2019-00012. BOLTON MEDICAL IS VOLUNTARILY REPORTING A DEVICE MALFUNCTION RELATED TO THE TREO ABDOMINAL STENT-GRAFT SYSTEM. THE TREO ABDOMINAL STENT-GRAFT 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). THE TREO ABDOMINAL STENT-GRAFT SYSTEM RELATED EVENT OCCURRED IN BELGIUM.

    Description of Event or Problem · 1

    "STENOSIS IN STENT ILIAC LEFT. SEVERITY: MODERATE. RELATEDNESS: RELATED TO DEVICE AND NOT RELATED TO PROCEDURE". PATIENT OUTCOME: "STENT + BALLOON. OUTCOME: RECOVERED. EVENT STOP DATE: 15 FEB 2019".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    209377 RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM STENT, ENDOVASCUALR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. B171113250

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention