BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM

    MDR report key: 7546106 · Received May 25, 2018

    Report

    Report Number
    2247858-2018-00134
    Event Type
    Injury
    Date Received
    May 25, 2018
    Date of Event
    April 16, 2018
    Report Date
    May 25, 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

    BOLTON MEDICAL IS VOLUNTARILY REPORTING A DEVICE MALFUNCTION RELATED TO A 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). THIS COMPLAINT WAS INVOLVED WITH 4 DEVICES: DEVICE 1 IS BEING REPORTED UNDER MDR 2247858-2018-00132. DEVICE 2 IS BEING REPORTED UNDER MDR 2247858-2018-00133. DEVICE 3 IS BEING REPORTED UNDER THIS REPORT. DEVICE 4 IS BEING REPORTED UNDER MDR 2247858-2018-00125.

    Description of Event or Problem · 1

    "THE PATIENT REPRESENTS HIMSELF WITH GENERAL MALAISE, ANOREXIA AND INFLAMMATORY BLOOD SAMPLES ON (B)(6) 2018. HOWEVER, FIRST COMPLAINT ABOUT GENERAL DISCONTENT WERE REPORTED DURING HIS 1 MONTH FOLLOW-UP VISIT ON (B)(6) 2018. THE LEUKOCYTE CT-SCAN SHOWED AN EXCESSIVE PSOAS ABSCESS (LEFT) EXTENDING FROM THE AORTA. THE ENDOGRAFT IS SURROUNDED BY FREE AIR. NO ENDOLEAK SEEN. PATIENT OUTCOME: "THE PATIENT IS TRANSFERRED TO THE UNIVERSITY HOSPITAL IN (B)(6) FOR FURTHER TREATMENT. THEY PLANNED THE FOLLOWING: DRAINAGE OF THE ABSCESS, EXPLANTATION OF THE ENDOGRAFT, REPLACEMENT BY CADAVER HOMOGRAFT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388718 RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM STENT, ENDOVASCULAR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. B171109020

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R