BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM

    MDR report key: 9560518 · Received January 7, 2020

    Report

    Report Number
    2247858-2020-00001
    Event Type
    Malfunction
    Date Received
    January 7, 2020
    Date of Event
    November 30, 2019
    Report Date
    March 12, 2020
    Manufacturer
    BOLTON MEDICAL, INC.
    Product Code
    MIH
    PMA / PMN Number
    P110038
    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 RELAY TRANSPORT THORACIC STENT-GRAFT SYSTEM. THE RELAY TRANSPORT 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 RELAY TRANSPORT RELATED EVENT OCCURRED IN CHINA.

    Description of Event or Problem · 0

    "PATIENTS DIAGNOSED WITH THORACIC DESCENDING AORTA MULTIPLE ULCERS MERGER INTRAMURAL HEMATOMA, CTA SHOWED NO OBVIOUS CALCIFIED PLAQUE, DIAMETER OF 27MM, RIGHT FEMORAL ARTERY DIAMETER 9.7 MM IN DIAMETER, 28 - M130155262285S INTRAOPERATIVE SELECTION MODEL, USED COOK HARD GUIDE WIRE TO DELIVER RELAY TRANSPORTATION SUPPORT SYSTEM. WHEN 10CM OF THE RELAY OUTER SHEATH INTO THE COMMON FEMORAL ARTERY, THE WHOLE SYSTEM GOT STUCK. DSA SCAN SHOWED TAPED GUIDE HEAD AND THE DELIVERY SYSTEM COLLAPSED AND SEPARATED. SO, THE DELIVERY SYSTEM COULDN'T PUSH. THE SURGEON HAD TO SLOWLY PULLED THE STENT SYSTEM OUT OF THE BODY, AND COST SEVERAL HOURS TO REMOVE THE DETACHED TAPED HEAD. THEREFORE, THE DOCTOR BELIEVED THAT THE STENT HAD QUALITY PROBLEMS AND REQUIRED IT TO BE SCRAPPED." PATIENT OUTCOME: "NO INJURY TO THE PATIENT."

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    "PATIENTS DIAGNOSED WITH THORACIC DESCENDING AORTA MULTIPLE ULCERS MERGER INTRAMURAL HEMATOMA, CTA SHOWED NO OBVIOUS CALCIFIED PLAQUE, DIAMETER OF 27MM, RIGHT FEMORAL ARTERY DIAMETER 9.7 MM IN DIAMETER, 28 - M130155262285S INTRAOPERATIVE SELECTION MODEL, USED COOK HARD GUIDE WIRE TO DELIVER RELAY TRANSPORTATION SUPPORT SYSTEM. WHEN 10CM OF THE RELAY OUTER SHEATH INTO THE COMMON FEMORAL ARTERY, THE WHOLE SYSTEM GOT STUCK. DSA SCAN SHOWED TAPED GUIDE HEAD AND THE DELIVERY SYSTEM COLLAPSED AND SEPARATED. SO, THE DELIVERY SYSTEM COULDN'T PUSH. THE SURGEON HAD TO SLOWLY PULLED THE STENT SYSTEM OUT OF THE BODY, AND COST SEVERAL HOURS TO REMOVE THE DETACHED TAPED HEAD. THEREFORE, THE DOCTOR BELIEVED THAT THE STENT HAD QUALITY PROBLEMS AND REQUIRED IT TO BE SCRAPPED." PATIENT OUTCOME: "NO INJURY TO THE PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24888 RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM STENT, ENDOVASCUALR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. B190711108

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other