BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM

    MDR report key: 6983312 · Received October 27, 2017

    Report

    Report Number
    2247858-2017-00017
    Event Type
    Injury
    Date Received
    October 27, 2017
    Date of Event
    September 28, 2017
    Report Date
    March 13, 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 · 0

    THIS COMPLAINT WAS INVOLVED WITH THREE DEVICES. DEVICE 1 IS BEING REPORTED UNDER THIS REPORT. DEVICE 2 IS BEING REPORTED UNDER MDR 2247858-2017-00018. DEVICE 3 IS BEING REPORTED UNDER MDR 2247858-2017-00019. 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 RELATED EVENT OCCURRED IN UK AND RESULTED IN EXPLANT OF THE DEVICES. THE EVENT DID NOT LEAD TO PATIENT DEATH. ATTACHMENT: [MDR 2247858-2017-00017 DEVICE 1 FOLLOW-UP EVALUATION.PDF].

    Description of Event or Problem · 0

    "PATIENT HAD TREO IMPLANTED TO TREAT AORTIC ANEURYSM, AFTER THE PATIENT ACQUIRED AND INFECTION, TREATED WITH ANTIBIOTICS, FURTHER INFO TO BE PROVIDED. BASICALLY DEVELOPED INTO MYCOTOC ANEURYSM WHICH MEANT THE GRAFT NEEDED TO BE EXPLANTED ON (B)(6) 2017."

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT WAS INVOLVED WITH THREE DEVICES. DEVICE 1 IS BEING REPORTED UNDER THIS MDR 2247858-2017-00017, DEVICE 2 IS BEING REPORTED UNDER MDR 2247858-2017-00018 AND DEVICE 3 IS BEING REPORTED UNDER MDR 2247858-2017-00019. BOLTON MEDICAL IS VOLUNTARILY REPORTING AN ADVERSE EVENT RELATED TO THE TREO ABDOMINAL STENT-GRAFT SYSTEM. THE TREO SYSTEM IS NOT MARKETED IN THE US, HOWEVER, BASED ON THE NATURE OF THIS EVENT IT IS CONSIDERED SIMILAR TO THE RELAY THORACIC STENT GRAFT WITH PLUS DELIVERY SYSTEM APPROVED FOR SALE IN THE US IN 2012 (P110038). THE TREO RELATED EVENT OCCURRED IN (B)(6) AND RESULTED IN EXPLANT OF THE DEVICES. THE EVENT DID NOT LEAD TO PATIENT DEATH.

    Description of Event or Problem · 1

    "PATIENT HAD TREO IMPLANTED TO TREAT AORTIC ANEURYSM, AFTER THE PATIENT ACQUIRED AND INFECTION, TREATED WITH ANTIBIOTICS, FURTHER INFO TO BE PROVIDED. BASICALLY DEVELOPED INTO MYCOTOC ANEURYSM WHICH MEANT THE GRAFT NEEDED TO BE EXPLANTED ON (B)(6) 2017."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762079 RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM STENT, ENDOVASCULAR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. B170105249

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other| R