BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM

    MDR report key: 11084020 · Received December 28, 2020

    Report

    Report Number
    2247858-2020-00079
    Event Type
    Injury
    Date Received
    December 28, 2020
    Date of Event
    December 3, 2020
    Report Date
    June 16, 2021
    Manufacturer
    BOLTON MEDICAL, INC.
    Product Code
    MIH
    PMA / PMN Number
    P110038
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BOLTON MEDICAL IS VOLUNTARILY REPORTING A DEVICE MALFUNCTION RELATED TO THE RELAYNBS PLUS THORACIC STENT-GRAFT SYSTEM. THE RELAYNBS PLUS 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 RELAYNBS PLUS RELATED EVENT OCCURRED IN PERU.

    Description of Event or Problem · 0

    DURING THE PERFORMANCE OF THE RELAY NBS COVERED THORACIC ENDOPROSTHESIS PLACEMENT PROCEDURE, THE PROXIMAL SAFETY OF THE ENDOPROSTHESIS WAS DISCONNECTED, WITHOUT HAVING PERFORMED ANY DELIVERY MANEUVER, REMAINING AT THE LEVEL OF THE ABDOMINAL AORTA, COMPROMISING THE VISCERAL VESSELS. THEREAFTER, PATIENT WAS ADMITTED TO THE OPERATING ROOM AS AN EMERGENCY FOR BYPASS SURGERY OF VISCERAL VESSELS. PATIENT OUTCOME - "-HEMODIALYSIS. -STANFORD B DISSECTION ENDOVASCULAR TREATMENT CULMINATED."

    Additional Manufacturer Narrative · 1

    BOLTON MEDICAL IS VOLUNTARILY REPORTING A DEVICE MALFUNCTION RELATED TO THE RELAYNBS PLUS THORACIC STENT-GRAFT SYSTEM. THE RELAYNBS PLUS 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 RELAYNBS PLUS RELATED EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    DURING THE PERFORMANCE OF THE RELAY NBS COVERED THORACIC ENDOPROSTHESIS PLACEMENT PROCEDURE, THE PROXIMAL SAFETY OF THE ENDOPROSTHESIS WAS DISCONNECTED, WITHOUT HAVING PERFORMED ANY DELIVERY MANEUVER, REMAINING AT THE LEVEL OF THE ABDOMINAL AORTA, COMPROMISING THE VISCERAL VESSELS. THEREAFTER, PATIENT WAS ADMITTED TO THE OPERATING ROOM AS AN EMERGENCY FOR BYPASS SURGERY OF VISCERAL VESSELS. PATIENT OUTCOME - "-HEMODIALYSIS. -STANFORD B DISSECTION ENDOVASCULAR TREATMENT CULMINATED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1549124 RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM STENT, ENDOVASCULAR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. B200924529

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention