BEUDAMED
    FDA Adverse Event Death Summary report: N

    RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM

    MDR report key: 7355580 · Received March 20, 2018

    Report

    Report Number
    2247858-2018-00110
    Event Type
    Death
    Date Received
    March 20, 2018
    Date of Event
    January 11, 2018
    Report Date
    June 29, 2018
    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 · 1

    BOLTON MEDICAL IS VOLUNTARILY REPORTING A DEVICE MALFUNCTION RELATED TO A RELAY TRANSPORT DEVICE. THE RELAY TRANSPORT DEVICE 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).

    Description of Event or Problem · 1

    "THE PATIENT HAD PAIN ON THE BACK TO COME TO THE HOSPITAL. AFTER CTA, IT WAS DIAGNOSED AS TYPE III DISSECTION. IN THE AFTERNOON OF THAT DAY, RELAY 85 WAS USED TO DO ENDOVASCULAR OPERATION. THE RIGHT FEMORAL ARTERY'S DIAMETER IS 8.5MM, AND THE RIGHT FEMORAL ARTERY WAS USED AS ACCESS. AFTER OPEN DEVICE, IT WAS FOUND THAT THE SHEATH WAS SEVERELY TORTUOUS. AFTER TALKING OF THE PHYSICIAN AND THE TECHNICAL PERSON, IT WAS DECIDED TO TRY. AND IT WAS DIFFICULT TO ADVANCE DURING THE OPERATION. AFTER SEVERAL TIMES OF TRY, THE SHEATH CAN'T PASS THE ILIAC ARTERY. THE SHEATH WAS WITHDRAWN AND THE OPERATION WAS SCHEDULED FOR ANOTHER DAY. THERE WAS SOME INTIMA LEFT ON THE SHEATH AFTER THE SHEATH WAS WITHDRAWN. THE NEXT DAY, THE PATIENT DIED." PATIENT OUTCOME: "THE PATIENT DIED AT THE NEXT DAY OF THE OPERATION."

    Description of Event or Problem · 1

    "THE PATIENT HAD PAIN ON THE BACK TO COME TO THE HOSPITAL. AFTER CTA, IT WAS DIAGNOSED AS TYPE III DISSECTION. IN THE AFTERNOON OF THAT DAY, RELAY 85 WAS USED TO DO ENDOVASCULAR OPERATION. THE RIGHT FEMORAL ARTERY'S DIAMETER IS 8.5 MM, AND THE RIGHT FEMORAL ARTERY WAS USED AS ACCESS. AFTER OPEN DEVICE, IT WAS FOUND THAT THE SHEATH WAS SEVERELY TORTUOUS. AFTER TALKING OF THE PHYSICIAN AND THE TECHNICAL PERSON, IT WAS DECIDED TO TRY. AND IT WAS DIFFICULT TO ADVANCE DURING THE OPERATION. AFTER SEVERAL TIMES OF TRY, THE SHEATH CAN'T PASS THE ILIAC ARTERY. THE SHEATH WAS WITHDRAWN AND THE OPERATION WAS SCHEDULED FOR ANOTHER DAY. THERE WAS SOME INTIMA LEFT ON THE SHEATH AFTER THE SHEATH WAS WITHDRAWN. THE NEXT DAY, THE PATIENT DIED." PATIENT OUTCOME: "THE PATIENT DIED AT THE NEXT DAY OF THE OPERATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195506 RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM STENT, ENDOVASCULAR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. B170531223

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death| R