BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM

    MDR report key: 9491399 · Received December 18, 2019

    Report

    Report Number
    2247858-2019-00082
    Event Type
    Malfunction
    Date Received
    December 18, 2019
    Date of Event
    November 20, 2019
    Report Date
    March 2, 2020
    Manufacturer
    BOLTON MEDICAL, INC.
    Product Code
    MIH
    PMA / PMN Number
    P110038
    Adverse Event
    Yes
    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 RELAYNBS PLUS THORACIC STENT-GRAFT SYSTEM. THE RELAYNBS PLUS 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 FRANCE.

    Description of Event or Problem · 0

    WHEN THE SURGEON TRIED TO PULL OUT THE TIP OF THE DEVICE THROUGH THE PERCUTANEOUS ACCESS, THE PROXIMAL PART STAYED BLOCKED IN THE FEMORAL ARTERY." PATIENT OUTCOME: "THE CONSEQUENCE FOR THE PATIENT WAS RELATED TO THE NEED OF ARTERIOTOMY (INITIALLY PERCUTANEOUS ACCESS) INDUCING A PROLONGED HOSPITALIZATION FOR 48 HOURS AND A SCAR ON THE FEMORAL RIGHT ACCESS."

    Additional Manufacturer Narrative · 1

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

    WHEN THE SURGEON TRIED TO PULL OUT THE TIP OF THE DEVICE THROUGH THE PERCUTANEOUS ACCESS, THE PROXIMAL PART STAYED BLOCKED IN THE FEMORAL ARTERY." PATIENT OUTCOME: "THE CONSEQUENCE FOR THE PATIENT WAS RELATED TO THE NEED OF ARTERIOTOMY (INITIALLY PERCUTANEOUS ACCESS) INDUCING A PROLONGED HOSPITALIZATION FOR 48 HOURS AND A SCAR ON THE FEMORAL RIGHT ACCESS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1286553 RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM STENT, ENDOVASCUALR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. B190711025

    Patients

    Seq Age Sex Outcome Treatment
    1 00 YR Hospitalization| R