BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM

    MDR report key: 9941171 · Received April 8, 2020

    Report

    Report Number
    2247858-2020-00018
    Event Type
    Injury
    Date Received
    April 8, 2020
    Date of Event
    March 5, 2020
    Report Date
    May 12, 2020
    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 RELAYNBS PLUS THORACIC STENT-GRAFT SYSTEM. THE RELAYNBS PLUS THORACIC 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 RELAYNBS PLUS THORACIC STENT-GRAFT SYSTEM RELATED EVENT OCCURRED IN GERMANY.

    Description of Event or Problem · 0

    "ELECTIVE STENT GRAFT EXTENSION ON (B)(6) 2020 DUE TO ENDOLEAK WITH ALREADY IMPLANTED THORACIC STENT GRAFT. AFTER EASY INSERTION (VIA A PERCUTANEOUS FEMORAL ACCESS ON THE RIGHT) AND REMOVAL OF THE STENT GRAFT, ALTHOUGH WE HAVE CARRIED OUT ALL OF THE STEPS CORRECTLY TO OUR KNOWLEDGE, WHEN THE INTRODUCER WAS WITHDRAWN, THERE WAS A DISCONNECTION BETWEEN THE OLIVE AT THE TIP AND THE REST OF THE CUTLERY. AS A RESULT, THE OLIVE GOT STUCK IN THE ACCESS VESSEL AND COULD NOT BE REMOVED PERCUTANEOUSLY. THERE WAS OPEN ACCESS TO THE INGUINAL VESSEL WITH SALVAGE OF THE OLIVE FROM THE VESSEL. ESTIMATED BLOOD LOSS OF 800 ML PERIOPERATIVE WITHOUT NEED FOR TRANSFUSION. THE PATIENT COULD BE TRANSFERRED DIRECTLY TO THE MONITORING STATION POSTOPERATIVELY." PATIENT OUTCOME: "THERE WAS A PROBLEM-FREE COURSE POSTOPERATIVELY. THE PATIENT COULD BE DISCHARGED HOME WITH DRY WOUNDS AND FULLY MOBILIZED."

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    "ELECTIVE STENT GRAFT EXTENSION ON (B)(6) 2020 DUE TO ENDOLEAK WITH ALREADY IMPLANTED THORACIC STENT GRAFT. AFTER EASY INSERTION (VIA A PERCUTANEOUS FEMORAL ACCESS ON THE RIGHT) AND REMOVAL OF THE STENT GRAFT, ALTHOUGH WE HAVE CARRIED OUT ALL OF THE STEPS CORRECTLY TO OUR KNOWLEDGE, WHEN THE INTRODUCER WAS WITHDRAWN, THERE WAS A DISCONNECTION BETWEEN THE OLIVE AT THE TIP AND THE REST OF THE CUTLERY. AS A RESULT, THE OLIVE GOT STUCK IN THE ACCESS VESSEL AND COULD NOT BE REMOVED PERCUTANEOUSLY. THERE WAS OPEN ACCESS TO THE INGUINAL VESSEL WITH SALVAGE OF THE OLIVE FROM THE VESSEL. ESTIMATED BLOOD LOSS OF 800 ML PERIOPERATIVE WITHOUT NEED FOR TRANSFUSION. THE PATIENT COULD BE TRANSFERRED DIRECTLY TO THE MONITORING STATION POSTOPERATIVELY." PATIENT OUTCOME: "THERE WAS A PROBLEM-FREE COURSE POSTOPERATIVELY. THE PATIENT COULD BE DISCHARGED HOME WITH DRY WOUNDS AND FULLY MOBILIZED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398659 RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM STENT, ENDOVASCUALR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. B171027104

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other| R