BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELAY BRANCH THORACIC STENT-GRAFT SYSTEM

    MDR report key: 13534082 · Received February 15, 2022

    Report

    Report Number
    2247858-2022-00030
    Event Type
    Malfunction
    Date Received
    February 15, 2022
    Date of Event
    February 9, 2022
    Report Date
    July 7, 2022
    Manufacturer
    BOLTON MEDICAL, INC.
    Product Code
    MIH
    PMA / PMN Number
    P200045
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BOLTON MEDICAL IS VOLUNTARILY REPORTING A DEVICE MALFUNCTION RELATED TO THE RELAY BRANCH THORACIC STENT-GRAFT SYSTEM. THE RELAY BRANCH DEVICE IS NOT MARKETED IN THE US; HOWEVER IT IS SIMILAR TO THE RELAY PRO THORACIC STENT GRAFT SYSTEM APPROVED FOR SALE IN THE US (P200045). THE RELAY BRANCH RELATED EVENT OCCURRED IN THE US. THIS RELAY BRANCH DEVICE WAS USED IN COMPASSIONATE USE CASE (B)(4).

    Additional Manufacturer Narrative · 0

    BOLTON MEDICAL IS VOLUNTARILY REPORTING A DEVICE MALFUNCTION RELATED TO THE RELAY BRANCH THORACIC STENT-GRAFT SYSTEM. THE RELAY BRANCH DEVICE IS NOT MARKETED IN THE US; HOWEVER IT IS SIMILAR TO THE RELAY PRO THORACIC STENT GRAFT SYSTEM APPROVED FOR SALE IN THE US ((B)(6)). THE RELAY BRANCH RELATED EVENT OCCURRED IN THE US. THIS RELAY BRANCH DEVICE WAS USED IN COMPASSIONATE USE CASE (B)(4).

    Description of Event or Problem · 0

    THE DEVICE WAS FLUSHED ON THE BACK TABLE AND ALL COMPONENTS INCLUDING THE APEX HOLDER KNOB WERE IN THE APPROPRIATE POSITIONS. THE DEVICE WAS BROUGHT TO THE SURGICAL TABLE AND INSERTED INTO THE PATIENT'S ACCESS VESSEL VIA A RIGHT COMMON ILIAC ARTERY CONDUIT. WHEN THE DEVICE WAS BEING ADVANCED IN THE DESCENDING AORTA IT WAS NOTED UNDER FLUOROSCOPY THAT THE TIP STARTED TO SEPARATE FROM THE SHEATH. THE CASE WAS PAUSED TO ANALYZE IF THE PROXIMAL CLASP HAD SEPARATED FROM THE DISTAL CLASP. AFTER IT WAS CONFIRMED TO STILL BE IN PLACE AND IT WAS DECIDED TO PROCEED SLOWLY TO THE DEPLOYMENT SITE. THE GRAFT WAS DEPLOYED SUCCESSFULLY AND IN THE INTENDED LANDING ZONE WITH NO DAMAGE TO THE PATIENT. THIS IS THE SECOND ATTEMPT FOR THIS COMPASSIONATE USE CASE, THE FIRST ONE BEING IN NOVEMBER OF 2021. A SIMILAR FAILURE OCCURRED DURING THIS CASE WHERE THE PROXIMAL CLASP DID SEPARATE FROM THE DISTAL CLASP AND THE CASE WAS ABORTED. AT THE TIME THE FAILURE WAS ATTRIBUTED TO THE ICAST DEVICE THAT WAS CAUGHT ON THE RELAYBRANCH DELIVERY SYSTEM CAUSING A POTENTIAL WEDGE BETWEEN THE TIP AND THE OUTER SHEATH. THE PATIENT HAD SEVERE SCOLIOSIS, SMALL ILIACS/ACCESS, AND PREVIOUSLY IMPLANTED ENDOVASCULAR DEVICES THAT COULD HAVE POTENTIALLY AFFECTED THE MECHANICS OF THE DEPLOYMENT. PATIENT OUTCOME - "THERE WAS NO NEGATIVE OUTCOME/PATIENT INJURY DUE TO THIS EVENT."

    Description of Event or Problem · 0

    THE DEVICE WAS FLUSHED ON THE BACK TABLE AND ALL COMPONENTS INCLUDING THE APEX HOLDER KNOB WERE IN THE APPROPRIATE POSITIONS. THE DEVICE WAS BROUGHT TO THE SURGICAL TABLE AND INSERTED INTO THE PATIENT'S ACCESS VESSEL VIA A RIGHT COMMON ILIAC ARTERY CONDUIT. WHEN THE DEVICE WAS BEING ADVANCED IN THE DESCENDING AORTA IT WAS NOTED UNDER FLUOROSCOPY THAT THE TIP STARTED TO SEPARATE FROM THE SHEATH. THE CASE WAS PAUSED TO ANALYZE IF THE PROXIMAL CLASP HAD SEPARATED FROM THE DISTAL CLASP. AFTER IT WAS CONFIRMED TO STILL BE IN PLACE AND IT WAS DECIDED TO PROCEED SLOWLY TO THE DEPLOYMENT SITE. THE GRAFT WAS DEPLOYED SUCCESSFULLY AND IN THE INTENDED LANDING ZONE WITH NO DAMAGE TO THE PATIENT. THIS IS THE SECOND ATTEMPT FOR THIS COMPASSIONATE USE CASE, THE FIRST ONE BEING IN (B)(6) 2021. A SIMILAR FAILURE OCCURRED DURING THIS CASE WHERE THE PROXIMAL CLASP DID SEPARATE FROM THE DISTAL CLASP AND THE CASE WAS ABORTED. AT THE TIME THE FAILURE WAS ATTRIBUTED TO THE ICAST DEVICE THAT WAS CAUGHT ON THE RELAYBRANCH DELIVERY SYSTEM CAUSING A POTENTIAL WEDGE BETWEEN THE TIP AND THE OUTER SHEATH. THE PATIENT HAD SEVERE SCOLIOSIS, SMALL ILIACS/ACCESS, AND PREVIOUSLY IMPLANTED ENDOVASCULAR DEVICES THAT COULD HAVE POTENTIALLY AFFECTED THE MECHANICS OF THE DEPLOYMENT. PATIENT OUTCOME - "THERE WAS NO NEGATIVE OUTCOME/PATIENT INJURY DUE TO THIS EVENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1344657 RELAY BRANCH THORACIC STENT-GRAFT SYSTEM STENT, ENDOVASCULAR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. 2201050131

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female