BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELAY PRO THORACIC STENT-GRAFT SYSTEM

    MDR report key: 16732152 · Received April 13, 2023

    Report

    Report Number
    2247858-2023-00093
    Event Type
    Injury
    Date Received
    April 13, 2023
    Date of Event
    March 22, 2023
    Report Date
    August 14, 2023
    Manufacturer
    BOLTON MEDICAL, INC.
    Product Code
    MIH
    PMA / PMN Number
    P200045
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BOLTON MEDICAL IS VOLUNTARILY REPORTING AN EVENT RELATED TO A RELAY PRO CUSTOM-MADE DEVICE. THE CUSTOM MADE RELAY PRO DEVICES ARE NOT MARKETED IN THE US, HOWEVER THEY ARE SIMILAR TO THE RELAY PRO THORACIC STENT GRAFT SYSTEM APPROVED FOR SALE IN THE US (P200045). THE EVENT OCCURRED IN FRANCE. BOLTON MEDICAL, INC. (D/B/A TERUMO AORTIC), HEREIN KNOWN AS THE "COMPANY", IS SUBMITTING THIS REPORT PURSUANT TO 21 CFR PART 803, HAS MADE REASONABLE EFFORTS TO OBTAIN COMPLETE INFORMATION, AND HAS PROVIDED AS MUCH AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT IS BASED ON INFORMATION OBTAINED BY THE COMPANY, WHICH MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE REGULATIONS. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN, UNAVAILABLE, OR NOT APPLICABLE. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY ANYONE THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE A LEGAL ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY DEFECTS OR HAS MALFUNCTIONED, AS DEFINED FROM A LEGAL STANDPOINT. THESE WORDS ARE INCLUDED IN THE REPORT AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE CERTAIN REGULATIONS, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Additional Manufacturer Narrative · 0

    BOLTON MEDICAL IS VOLUNTARILY REPORTING AN EVENT RELATED TO A RELAY PRO CUSTOM-MADE DEVICE. THE CUSTOM MADE RELAY PRO DEVICES ARE NOT MARKETED IN THE US, HOWEVER THEY ARE SIMILAR TO THE RELAY PRO THORACIC STENT GRAFT SYSTEM APPROVED FOR SALE IN THE US (P200045). THE EVENT OCCURRED IN FRANCE.

    Description of Event or Problem · 0

    RELAY DB CASE. WE WERE AT THE BEGINNING OF THE PROCEDURE. WHILE DR DAVAINE WAS SCREWING THE BLACK DEPLOYMENT GRIP IN POSITION 1 FOR ADVANCING THE INTERNAL SHEATH (AND THE DEVICE) IN THE ARCH ON A LUNDERQUIST WIRE (THAT WAS IN PLACE IN THE LEFT VENTRICLE), THE DEVICE STARTED TO OPEN IN A WRONG PLACE (JUST IN FRONT OF BCT). DR DAVAINE WELL FOLLOWED THE INSTRUCTIONS BY SCREWING THE BLACK DEPLOYMENT GRIP (CLOCKWISE) AND MAINTAINING THE GREY HANDLE WITH THE CONTROL KNOW IN POSITION 1. DURING THE LAST MOVEMENT BEFORE I ASKED TO STOP, IT HAS SEEMED THAT ONLY THE TIP AND THE DEVICE PROGRESSED WHILE THE POLYESTER SHEATH WAS "BLOCKED" WHAT HAS OPENED THE 1ST STENT IN THE ARCH, IN FRONT OF THE BCT. THERE WAS NO SPECIAL ANGULATION OR EVENT THAT COULD EXPLAIN THAT THE GRAFT HAS STARTED TO DEPLOY. WE WELL FOLLOWED THE STEPS THAT ARE DESCRIBED IN THE RELAY PRO IFU (STEP 1) PATIENT OUTCOME - "IT WAS IMPOSSIBLE TO RELEASE THE DEVICE IN THE DESCENDING AORTA: THORACIC ABDOMINAL ANEURYSM. THE DEVICE WASN'T FIT TO SEAL IN THE DESCENDING AND THE RISK WOULD HAVE BEEN A DISTAL MIGRATION WITH A COVERAGE OF THE VISCERAL AORTA (AND CONVERSION TO OPEN REPAIR). THE SURGEON DECIDES TO PULL ON THE WHOLE DEVICE TO EXPLANT IT. BY DOING THIS, THE RIGHT REIA AND THE RCFA HAS BEEN PULLED OFF. IT HAS PROVOKED AN IMPORTANT BLEEDING THAT DR DAVAINE HANDLED WITH DIFFICULTIES. THE PATIENT HAS RECEIVED A BLOOD TRANSFUSION DURING THE REPAIR. AN ILIO-FEMORAL BYPASS HAS BEEN PERFORMED FOR ENSURING HEMOSTASIS AND THE RIGHT LEG VASCULARIZATION. THE DEVICE AND THE DS ARE STILL IN THE HOSPITAL BECAUSE THE PHARMACY HAS ALSO AN INTERNAL PROCESS FOR THIS KIND OF EVENT. THEY WAIT FOR DR DAVAINE COMMENTS AND DECLARATION OF THE ADVERSE EVENT FOR CONTACTING US. THEN THEY WILL SHIP THE DEVICE TO TAF, THAT WE WILL SHIP TO SUNRISE FOR ANALYSIS."

    Description of Event or Problem · 0

    RELAY DB CASE. WE WERE AT THE BEGINNING OF THE PROCEDURE. WHILE DR (B)(6) WAS SCREWING THE BLACK DEPLOYMENT GRIP IN POSITION 1 FOR ADVANCING THE INTERNAL SHEATH (AND THE DEVICE) IN THE ARCH ON A LUNDERQUIST WIRE (THAT WAS IN PLACE IN THE LEFT VENTRICLE), THE DEVICE STARTED TO OPEN IN A WRONG PLACE (JUST IN FRONT OF BCT). DR (B)(6) WELL FOLLOWED THE INSTRUCTIONS BY SCREWING THE BLACK DEPLOYMENT GRIP (CLOCKWISE) AND MAINTAINING THE GREY HANDLE WITH THE CONTROL KNOW IN POSITION 1. DURING THE LAST MOVEMENT BEFORE I ASKED TO STOP, IT HAS SEEMED THAT ONLY THE TIP AND THE DEVICE PROGRESSED WHILE THE POLYESTER SHEATH WAS "BLOCKED" WHAT HAS OPENED THE 1ST STENT IN THE ARCH, IN FRONT OF THE BCT. THERE WAS NO SPECIAL ANGULATION OR EVENT THAT COULD EXPLAIN THAT THE GRAFT HAS STARTED TO DEPLOY. WE WELL FOLLOWED THE STEPS THAT ARE DESCRIBED IN THE RELAY PRO IFU (STEP 1). PATIENT OUTCOME - "IT WAS IMPOSSIBLE TO RELEASE THE DEVICE IN THE DESCENDING AORTA: THORACIC ABDOMINAL ANEURYSM. THE DEVICE WASN'T FIT TO SEAL IN THE DESCENDING AND THE RISK WOULD HAVE BEEN A DISTAL MIGRATION WITH A COVERAGE OF THE VISCERAL AORTA (AND CONVERSION TO OPEN REPAIR). THE SURGEON DECIDES TO PULL ON THE WHOLE DEVICE TO EXPLANT IT. BY DOING THIS, THE RIGHT REIA AND THE RCFA HAS BEEN PULLED OFF. IT HAS PROVOKED AN IMPORTANT BLEEDING THAT DR (B)(6) HANDLED WITH DIFFICULTIES. THE PATIENT HAS RECEIVED A BLOOD TRANSFUSION DURING THE REPAIR. AN ILIO-FEMORAL BYPASS HAS BEEN PERFORMED FOR ENSURING HEMOSTASIS AND THE RIGHT LEG VASCULARIZATION. THE DEVICE AND THE DS ARE STILL IN THE HOSPITAL BECAUSE THE PHARMACY HAS ALSO AN INTERNAL PROCESS FOR THIS KIND OF EVENT. THEY WAIT FOR DR (B)(6) COMMENTS AND DECLARATION OF THE ADVERSE EVENT FOR CONTACTING US. THEN THEY WILL SHIP THE DEVICE TO TAF, THAT WE WILL SHIP TO SUNRISE FOR ANALYSIS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1243934 RELAY PRO THORACIC STENT-GRAFT SYSTEM STENT, ENDOVASCULAR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. 2211290190

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Required Intervention