BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM

    MDR report key: 8562388 · Received April 29, 2019

    Report

    Report Number
    2247858-2019-00023
    Event Type
    Injury
    Date Received
    April 29, 2019
    Date of Event
    March 15, 2019
    Report Date
    June 5, 2019
    Manufacturer
    BOLTON MEDICAL, INC.
    Product Code
    MIH
    PMA / PMN Number
    P110038
    Adverse Event
    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 STENT-GRAFT SYSTEM. THE RELAY TRANSPORT STENT-GRAFT SYSTEM 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 STENT-GRAFT SYSTEM RELATED EVENT OCCURRED IN CHINA.

    Description of Event or Problem · 0

    "THE PATIENT HAD A HUGE AORTIC ARCH ANEURYSM, AND THE INTERNAL STRUCTURE OF THE TUMOR WAS TOO COMPLEX TO PASS THROUGH. SO THE SOFT SHEATH COULD NOT FOLLOW THE SUPER HARD GUIDEWIRE TO REACH THE ANCHORING POSITION. THE SURGEON HAD NO CHOICE BUT TO ABANDON THE INTRACAVITARY REPAIRMENT. THE STENT WAS SCRAPPED. AND THE SURGEON DID AN OPEN SURGICAL TREATMENT TO FINISH THE PROCEDURE OF CURE." PATIENT OUTCOME: "THE STENT WAS SCRAPPED. AND THE SURGEON DID A OPEN SURGICAL TREATMENT TO FINISH THE PROCEDURE OF CURE."

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    "THE PATIENT HAD A HUGE AORTIC ARCH ANEURYSM, AND THE INTERNAL STRUCTURE OF THE TUMOR WAS TOO COMPLEX TO PASS THROUGH. SO THE SOFT SHEATH COULD NOT FOLLOW THE SUPER HARD GUIDEWIRE TO REACH THE ANCHORING POSITION. THE SURGEON HAD NO CHOICE BUT TO ABANDON THE INTRACAVITARY REPAIRMENT. THE STENT WAS SCRAPPED. AND THE SURGEON DID AN OPEN SURGICAL TREATMENT TO FINISH THE PROCEDURE OF CURE." PATIENT OUTCOME: "THE STENT WAS SCRAPPED. AND THE SURGEON DID A OPEN SURGICAL TREATMENT TO FINISH THE PROCEDURE OF CURE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355969 RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM STENT, ENDOVASCUALR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. B170828205

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention