BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELAY NBS PRO THORACIC STENT-GRAFT

    MDR report key: 15607719 · Received October 14, 2022

    Report

    Report Number
    2247858-2022-00156
    Event Type
    Injury
    Date Received
    October 14, 2022
    Date of Event
    September 21, 2022
    Report Date
    January 10, 2023
    Manufacturer
    BOLTON MEDICAL, INC.
    Product Code
    MIH
    PMA / PMN Number
    P200045
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    BOLTON MEDICAL IS VOLUNTARILY REPORTING AN EVENT RELATED TO A RELAY NBS PRO CUSTOM-MADE DEVICE. THE CUSTOM MADE RELAY NBS PRO DEVICES ARE NOT MARKETED IN THE US, HOWEVER THEY ARE SIMILAR TO THE RELAY NBS PRO THORACIC STENT GRAFT SYSTEM APPROVED FOR SALE IN THE US ((B)(6)). THE EVENT OCCURRED IN CANADA.

    Description of Event or Problem · 0

    WHILE ADVANCING THE SYSTEM INTO THE PROXIMAL LADING ZONE IN "POSITION 1" THERE WERE SOME CHALLENGES GETTING TO THE PROXIMAL LANDING ZONE DUE TO WHAT APPEARED TO BE A BIT OF A LEDGE NEAR THE PREVIOUS AORTIC REPAIR/ANASTOMOSIS. THE NOSE CONE APPEARED TO MAKE IT PAST THIS LEDGE HOWEVER THE UNION BETWEEN THE NOSE CONE AND INNER SHEATH WOULD NOT ADVANCE. WE THEN NOTICED THAT THE INNER SHEATH HAD PARTIALLY DISLODGED FROM THE NOSE CONE AND THE SG HAD STARTED TO BUTTERFLY. THE SG COULD NOT BE DEPLOYED AT THIS POINT AS THE PHYSICIANS FELT WE WERE STILL TOO DISTAL. THE WHOLE SYSTEM WAS PULLED BACK HOWEVER DUE TO THE PARTIALLY DEPLOYED SG IT WOULD NOT TRACK BACK DOWN THE AORTA. MULTIPLE ATTEMPTS WERE MADE TO PULL IT BACK INTO THE OUTER SHEATH HOWEVER THIS WAS UNSUCCESSFUL. AFTER RETRACTING THE ENTIRE DELIVERY SYSTEM TO THE AORTIC BIFURCATION (INNER SHEATH STILL OUTSIDE THE OUTER SHEATH) IT BECAME OBVIOUS THAT THE SG COULD NOT BE REMOVED FROM THE PATIENT WITHOUT TEARING THE FEMORAL ARTERY. THE DECISION WAS MADE TO DEPLOY THE SG IN THE PATIENTS RIGHT COMMON ILIAC IN ORDER TO GET THE DELIVERY SYSTEM OUT INTACT. THE SG WAS DEPLOYED SUCCESSFULLY HOWEVER WHILE IN POSITION 4 AND PULLING THE NOSE CONE BACK INTO THE DELIVERY SYSTEM THE NOSE CONE DETACHED INSIDE THE SG IN THE PATIENTS ILIAC. THE REST OF THE COMPONENTS WERE REMOVED SUCCESSFULLY. THE SG AND NOSE CONE WERE LEFT IN THE PATIENT. AN AUI DEVICE WAS THEN PLACED, AND SUCCESSFUL FEM-FEM CROSSOVER WAS COMPLETED AS THE RCIA WAS NOW OCCLUDED. OVERALL DR. PRICE, DR KLASS AND DR FAULDS WERE REALLY GOOD ABOUT THE SITUATION AND LEVELHEADED. THEY ARE INTERESTED IN A DEBRIEF WITH THE TA TEAM INCLUDING CLINICIANS AND ENGINEERS EARLY NEXT WEEK. IMAGING WILL BE PROVIDED AT THAT TIME. ALL COMPONENTS (ASIDE FROM THOSE LEFT IN THE PATIENT) ARE AVAILABLE TO RETURN TO TA. PATIENT OUTCOME - "AN AUI DEVICE WAS THEN PLACED, AND SUCCESSFUL FEM-FEM CROSSOVER WAS COMPLETED AS THE RCIA WAS NOW OCCLUDED. PATIENT WAS EXTUBATED AND DOING WELL."

    Description of Event or Problem · 0

    WHILE ADVANCING THE SYSTEM INTO THE PROXIMAL LADING ZONE IN "POSITION 1" THERE WERE SOME CHALLENGES GETTING TO THE PROXIMAL LANDING ZONE DUE TO WHAT APPEARED TO BE A BIT OF A LEDGE NEAR THE PREVIOUS AORTIC REPAIR/ANASTOMOSIS. THE NOSE CONE APPEARED TO MAKE IT PAST THIS LEDGE HOWEVER THE UNION BETWEEN THE NOSE CONE AND INNER SHEATH WOULD NOT ADVANCE. WE THEN NOTICED THAT THE INNER SHEATH HAD PARTIALLY DISLODGED FROM THE NOSE CONE AND THE SG HAD STARTED TO BUTTERFLY. THE SG COULD NOT BE DEPLOYED AT THIS POINT AS THE PHYSICIANS FELT WE WERE STILL TOO DISTAL. THE WHOLE SYSTEM WAS PULLED BACK HOWEVER DUE TO THE PARTIALLY DEPLOYED SG IT WOULD NOT TRACK BACK DOWN THE AORTA. MULTIPLE ATTEMPTS WERE MADE TO PULL IT BACK INTO THE OUTER SHEATH HOWEVER THIS WAS UNSUCCESSFUL. AFTER RETRACTING THE ENTIRE DELIVERY SYSTEM TO THE AORTIC BIFURCATION (INNER SHEATH STILL OUTSIDE THE OUTER SHEATH) IT BECAME OBVIOUS THAT THE SG COULD NOT BE REMOVED FROM THE PATIENT WITHOUT TEARING THE FEMORAL ARTERY. THE DECISION WAS MADE TO DEPLOY THE SG IN THE PATIENTS RIGHT COMMON ILIAC IN ORDER TO GET THE DELIVERY SYSTEM OUT INTACT. THE SG WAS DEPLOYED SUCCESSFULLY HOWEVER WHILE IN POSITION 4 AND PULLING THE NOSE CONE BACK INTO THE DELIVERY SYSTEM THE NOSE CONE DETACHED INSIDE THE SG IN THE PATIENTS ILIAC. THE REST OF THE COMPONENTS WERE REMOVED SUCCESSFULLY. THE SG AND NOSE CONE WERE LEFT IN THE PATIENT. AN AUI DEVICE WAS THEN PLACED, AND SUCCESSFUL FEM-FEM CROSSOVER WAS COMPLETED AS THE RCIA WAS NOW OCCLUDED. OVERALL DR. (B)(6), DR (B)(6) AND DR (B)(6) WERE REALLY GOOD ABOUT THE SITUATION AND LEVELHEADED. THEY ARE INTERESTED IN A DEBRIEF WITH THE TA TEAM INCLUDING CLINICIANS AND ENGINEERS EARLY NEXT WEEK. IMAGING WILL BE PROVIDED AT THAT TIME. ALL COMPONENTS (ASIDE FROM THOSE LEFT IN THE PATIENT) ARE AVAILABLE TO RETURN TO TA. PATIENT OUTCOME - "AN AUI DEVICE WAS THEN PLACED, AND SUCCESSFUL FEM-FEM CROSSOVER WAS COMPLETED AS THE RCIA WAS NOW OCCLUDED. PATIENT WAS EXTUBATED AND DOING WELL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2340549 RELAY NBS PRO THORACIC STENT-GRAFT STENT, ENDOVASCULAR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. 2205180303

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male Required Intervention| O