BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELAY NBS THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM

    MDR report key: 16091473 · Received January 3, 2023

    Report

    Report Number
    2247858-2023-00001
    Event Type
    Malfunction
    Date Received
    January 3, 2023
    Date of Event
    December 10, 2022
    Report Date
    April 11, 2023
    Manufacturer
    BOLTON MEDICAL, INC.
    Product Code
    MIH
    PMA / PMN Number
    P110038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BOLTON MEDICAL IS VOLUNTARILY REPORTING AN EVENT RELATED TO A RELAY NBS THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM. THE RELAY NBS PLUS DEVICE IS NOT MARKETED IN THE US, HOWEVER IT IS SIMILAR TO THE RELAY PLUS THORACIC STENT GRAFT SYSTEM APPROVED FOR SALE IN THE US (P110038). THE EVENT OCCURRED IN THAILAND.

    Additional Manufacturer Narrative · 0

    BOLTON MEDICAL IS VOLUNTARILY REPORTING AN EVENT RELATED TO A RELAY NBS THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM. THE RELAY NBS PLUS DEVICE IS NOT MARKETED IN THE US, HOWEVER IT IS SIMILAR TO THE RELAY PLUS THORACIC STENT GRAFT SYSTEM APPROVED FOR SALE IN THE US (P110038). THE EVENT OCCURRED IN THAILAND.

    Description of Event or Problem · 0

    PRODUCT COMPLAINT: RELAY NBS PLUS THORACIC STENT GRAFT, CATALOG #: 28-N2-30-209-26-2390S, LOT: B220520019. THE PLAN: TEVAR FROM ZONE 3 WITH PARTIAL COVER LEFT SUBCLAVIAN TO DESCENDING AORTA, TOTAL LENGTH WAS 250 MM WITH 28-N2-30-209-26-2390S AND 28-N2-30-164-26-2290S. ON THE PROCEDURE: AFTER PLACE THE CONTROLLER IN THE "4" POSITION AND MAKE AN ANGIOGRAM TO CONFIRM POSITION. THE PHYSICIAN RETRACTED THE STAINLESS-STEEL ROD AND PULL THE STAINLESS-STEEL ROD DISTALLY. BUT THE TIP WAS DISCONNECTED FROM THE DELIVERY SYSTEM INSIDE PATIENT'S VESSEL AT DESCENDING THORACIC AORTA (T10-T11 LEVEL) AS THE PICTURE IN ATTACHED. THEN THE PHYSICIAN TRIED TO TAKE OFF WHOLE DELIVERY SYSTEM FROM PATIENT WITH USING THE SNARE. PATIENT OUTCOME: "THE PROCEDURE WAS CONVERTED FROM PRE-CLOSURE TO CUTDOWN. THE WOUND SIZE WAS OPENED AT FEMORAL VESSEL FROM 7-8 MM TO 40-50 MM. THE DOCTOR NEED INVESTIGATING AND REQUIRE FREE OF CHARGE."

    Description of Event or Problem · 0

    PRODUCT COMPLAINT: RELAY NBS PLUS THORACIC STENT GRAFT 28-N2-30-209-26-2390S LOT: B220520019. THE PLAN: TEVAR FROM ZONE 3 WITH PARTIAL COVER LEFT SUBCLAVIAN TO DESCENDING AORTA, TOTAL LENGTH WAS 250 MM WITH 28-N2-30-209-26-2390S AND 28-N2-30-164-26-2290S ON THE PROCEDURE: AFTER PLACE THE CONTROLLER IN THE "4" POSITION AND MAKE AN ANGIOGRAM TO CONFIRM POSITION. THE PHYSICIAN RETRACTED THE STAINLESS-STEEL ROD AND PULL THE STAINLESS-STEEL ROD DISTALLY. BUT THE TIP WAS DISCONNECTED FROM THE DELIVERY SYSTEM INSIDE PATIENT'S VESSEL AT DESCENDING THORACIC AORTA (T10-T11 LEVEL) AS THE PICTURE IN ATTACHED. THEN THE PHYSICIAN TRIED TO TAKE OFF WHOLE DELIVERY SYSTEM FROM PATIENT WITH USING THE SNARE. PATIENT OUTCOME - "THE PROCEDURE WAS CONVERTED FROM PRE-CLOSURE TO CUTDOWN. THE WOUND SIZE WAS OPENED AT FEMORAL VESSEL FROM 7-8 MM TO 40-50 MM. THE DOCTOR NEED INVESTIGATING AND REQUIRE FREE OF CHARGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139597 RELAY NBS THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM STENT, ENDOVASCULAR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. B220520019

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Required Intervention