BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELAY PRO THORACIC STENT-GRAFT SYSTEM

    MDR report key: 14135169 · Received April 18, 2022

    Report

    Report Number
    2247858-2022-00063
    Event Type
    Injury
    Date Received
    April 18, 2022
    Date of Event
    April 5, 2022
    Report Date
    October 31, 2022
    Manufacturer
    BOLTON MEDICAL, INC.
    Product Code
    MIH
    PMA / PMN Number
    P200045
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BOLTON MEDICAL IS VOLUNTARILY REPORTING AN EVENT RELATED TO A RELAY PRO FENESTRATED CUSTOM-MADE DEVICE. THE CUSTOM MADE RELAY TRIPLE BRANCH DEVICE IS NOT MARKETED IN THE US, HOWEVER IT IS SIMILAR TO THE RELAY PRO THORACIC STENT GRAFT SYSTEM APPROVED FOR SALE IN THE US (P200045). THE EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    BECAUSE OF KINKED ANATOMY IN COMBINATION WITH PREVIOUSLY IMPLANTED EVAR IT WAS DIFFICULT FOR THE DELIVERY SYSTEM TO PASS WITH LOTS OF FRICTION. AFTER INTRODUCING THE DEVICE ABOVE THE EVAR IT WAS DIFFICULT TO PUT THE DEVICE INTO THE CORRECT POSITION. BUT IT WAS HARD TO ESTIMATE HOW MUCH FORCE WAS USED TO TRY TO ROTATE THE DEVICE. WE DECIDED TO ADVANCE THE GRAFT IN POSITION 1 FOR TWO STENT STRUTS. AFTERWARDS SOME ADDITIONAL ROTATION TRYOUTS WERE PERFORMED. WHEN THE RESULT WAS FINALLY ACCEPTABLE, WE ADVANCED THE GRAFT INTO THE ARCH SMOOTHLY. AT THE HEIGHT OF THE LSA SUDDENLY THE FIRST STENTS OPENED A LITTLE BIT. WE DECIDED TO ADVANCE INTO THE FINAL POSITION WITH TO RELEASE THE GRAFT COMPLETELY. IT WAS STILL DIFFICULT AS THERE WASN´T A GOOD PUSH ABILITY. WHEN FINALLY REACHING THE AIMED POSITION AND SWITCHING TO POSITION 2, IT WASN´T POSSIBLE TO RELEASE THE GRAFT. AS IT WASN´T POSSIBLE TO RETRIEVE THE DEVICE DISTALLY AS IT WAS PARTIALLY OPENED THE PHYSICIAN DECIDED TO SWITCH TO OPEN REPAIR WITH FET. THE GRAFT WAS OPENED AND REMOVED PROXIMALLY THROUGH THE ASCENDING AORTA AND THE DELIVERY-SYSTEM WAS PULLED BACK AFTERWARDS. BECAUSE OF INTERNAL REGULATIONS OF THE HOSPITAL THE DEVICE HAS FIRST GO TO INTERNAL SAFETY ANALYSIS. PATIENT OUTCOME: "THE FET PROCEDURE WITH ELONGATION TO THE DESCENDING AORTA WAS PERFORMED SUCCESSFULLY WITH A LATER REPAIR OF THE FEMORAL DURING THE NIGHT AS THE DEVICE BLOCKED THE LEG FLOW FOR QUITE A LONG TIME AND THE PHYSICIAN INSTALLED AN EXTRACORPOREAL CIRCULATION FOR IT IN COMBINATION WITH THE HLM. LONG TERM OUTCOME IS STILL UNKNOWN."

    Description of Event or Problem · 0

    BECAUSE OF KINKED ANATOMY IN COMBINATION WITH PREVIOUSLY IMPLANTED EVAR IT WAS DIFFICULT FOR THE DELIVERY SYSTEM TO PASS WITH LOTS OF FRICTION. AFTER INTRODUCING THE DEVICE ABOVE THE EVAR IT WAS DIFFICULT TO PUT THE DEVICE INTO THE CORRECT POSITION. BUT IT WAS HARD TO ESTIMATE HOW MUCH FORCE WAS USED TO TRY TO ROTATE THE DEVICE. WE DECIDED TO ADVANCE THE GRAFT IN POSITION 1 FOR TWO STENT STRUTS. AFTERWARDS SOME ADDITIONAL ROTATION TRYOUTS WERE PERFORMED. WHEN THE RESULT WAS FINALLY ACCEPTABLE, WE ADVANCED THE GRAFT INTO THE ARCH SMOOTHLY. AT THE HEIGHT OF THE LSA SUDDENLY THE FIRST STENTS OPENED A LITTLE BIT. WE DECIDED TO ADVANCE INTO THE FINAL POSITION WITH TO RELEASE THE GRAFT COMPLETELY. IT WAS STILL DIFFICULT AS THERE WASN´T A GOOD PUSH ABILITY. WHEN FINALLY REACHING THE AIMED POSITION AND SWITCHING TO POSITION 2, IT WASN´T POSSIBLE TO RELEASE THE GRAFT. AS IT WASN´T POSSIBLE TO RETRIEVE THE DEVICE DISTALLY AS IT WAS PARTIALLY OPENED THE PHYSICIAN DECIDED TO SWITCH TO OPEN REPAIR WITH FET. THE GRAFT WAS OPENED AND REMOVED PROXIMALLY THROUGH THE ASCENDING AORTA AND THE DELIVERY-SYSTEM WAS PULLED BACK AFTERWARDS. BECAUSE OF INTERNAL REGULATIONS OF THE HOSPITAL THE DEVICE HAS FIRST GO TO INTERNAL SAFETY ANALYSIS. PATIENT OUTCOME - "THE FET PROCEDURE WITH ELONGATION TO THE DESCENDING AORTA WAS PERFORMED SUCCESSFULLY WITH A LATER REPAIR OF THE FEMORAL DURING THE NIGHT AS THE DEVICE BLOCKED THE LEG FLOW FOR QUITE A LONG TIME AND THE PHYSICIAN INSTALLED AN EXTRACORPOREAL CIRCULATION FOR IT IN COMBINATION WITH THE HLM. LONG TERM OUTCOME IS STILL UNKNOWN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    657840 RELAY PRO THORACIC STENT-GRAFT SYSTEM STENT, ENDOVASCULAR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. 2202220241

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Required Intervention