BEUDAMED
    FDA Adverse Event Death Summary report: N

    RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM

    MDR report key: 8418173 · Received March 13, 2019

    Report

    Report Number
    2247858-2019-00013
    Event Type
    Death
    Date Received
    March 13, 2019
    Date of Event
    February 19, 2019
    Report Date
    April 2, 2019
    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

    CORRECTION TO INCLUDE THE ATTACHMENT WITH THE DEVICE EVALUATION - ATTACHMENT: [MDR 2247858-2019-00013 FOLLOW-UP EVALUATION.PDF]

    Description of Event or Problem · 0

    "UPON INSERTION OF THE DEVICE AFTER SERIAL DILATORS UP TO 20FR WERE INSERTED, WE ATTEMPTED TO DELIVER THE DEVICE. THE DEVICE-A 42X38X250 BEGAN TO TRAVERSE THE VERY TORTUOUS ANATOMY BUT BECAME INCREASINGLY HARD TO ADVANCE AND THE PHYSICIAN NOTICED THAT JUST DISTAL TO WHERE THE GRAFT IS LOADED INTO THE DELIVERY SYSTEM A KINK HAD FORMED ON THE DELIVERY SYSTEM. WE TRIED TO ADVANCE THE SYSTEM AGAIN WITH SOME EXTERNAL MANUAL PRESSURE BUT THE SYSTEM WOULD NOT ADVANCE. THE DEVICE WAS REMOVED AND NO DROP IN BLOOD PRESSURE WAS OBSERVED. THE PHYSICIAN THEN INSERTED A 26FR SHEATH TO TRY AND HELP THE DEVICE GET DELIVERED. THE SHEATH WENT UP. THE GRAFT WAS THEN RE-INSERTED AND NO ISSUE OF TRACKABILITY WAS OBSERVED HOWEVER AS THE DEVICE TRAVERSED UP THE DESCENDING AORTA THE ANESTHESIOLOGIST NOTICED THAT THE PTS PRESSURE HAD DROPPED. WE IMMEDIATELY OPENED THE FLUIDS, PULLED THE GRAFT OUT AND STARTED TO TAKE PICTURES. WE THEN SAW EXTRAVIZATION BACK AROUND BEHIND THE GRAFT. THE PHYSICIAN THEN DECIDED TO OPEN AFTER TRYING TO CLOSE IT OFF WITH A CUFF AND AFTER MUCH DISSECTING AND REPAIR IT WAS FOUND THAT THERE WAS A HOLE ACTUALLY IN THE DISTAL AORTA BUT NOT IN THE ENDOGRAFT. IT WAS THEREFORE ASSUMED THAT EITHER ALL THE MANIPULATION OR SHEATH PLACEMENT OR A COMBO OF BOTH CAUSED THE NATIVE AORTA TO TEAR. THE PATIENT SUBSEQUENTLY DIED." PATIENT OUTCOME: "THE PATIENT HAS DIED. I WAS INFORMED ON (B)(6) 2019 AT APPROX. 7:40PM."

    Description of Event or Problem · 0

    "UPON INSERTION OF THE DEVICE AFTER SERIAL DILATORS UP TO 20FR WERE INSERTED, WE ATTEMPTED TO DELIVER THE DEVICE. THE DEVICE-A 42X38X250 BEGAN TO TRAVERSE THE VERY TORTUOUS ANATOMY BUT BECAME INCREASINGLY HARD TO ADVANCE AND THE PHYSICIAN NOTICED THAT JUST DISTAL TO WHERE THE GRAFT IS LOADED INTO THE DELIVERY SYSTEM A KINK HAD FORMED ON THE DELIVERY SYSTEM. WE TRIED TO ADVANCE THE SYSTEM AGAIN WITH SOME EXTERNAL MANUAL PRESSURE BUT THE SYSTEM WOULD NOT ADVANCE. THE DEVICE WAS REMOVED AND NO DROP IN BLOOD PRESSURE WAS OBSERVED. THE PHYSICIAN THEN INSERTED A 26FR SHEATH TO TRY AND HELP THE DEVICE GET DELIVERED. THE SHEATH WENT UP. THE GRAFT WAS THEN RE-INSERTED AND NO ISSUE OF TRACKABILITY WAS OBSERVED HOWEVER AS THE DEVICE TRAVERSED UP THE DESCENDING AORTA THE ANESTHESIOLOGIST NOTICED THAT THE PTS PRESSURE HAD DROPPED. WE IMMEDIATELY OPENED THE FLUIDS, PULLED THE GRAFT OUT AND STARTED TO TAKE PICTURES. WE THEN SAW EXTRAVIZATION BACK AROUND BEHIND THE GRAFT. THE PHYSICIAN THEN DECIDED TO OPEN AFTER TRYING TO CLOSE IT OFF WITH A CUFF AND AFTER MUCH DISSECTING AND REPAIR IT WAS FOUND THAT THERE WAS A HOLE ACTUALLY IN THE DISTAL AORTA BUT NOT IN THE ENDOGRAFT. IT WAS THEREFORE ASSUMED THAT EITHER ALL THE MANIPULATION OR SHEATH PLACEMENT OR A COMBO OF BOTH CAUSED THE NATIVE AORTA TO TEAR. THE PATIENT SUBSEQUENTLY DIED." PATIENT OUTCOME: "THE PATIENT HAS DIED. I WAS INFORMED ON (B)(6) 2019 AT APPROX. 7:40PM."

    Description of Event or Problem · 1

    "UPON INSERTION OF THE DEVICE AFTER SERIAL DILATORS UP TO 20FR WERE INSERTED, WE ATTEMPTED TO DELIVER THE DEVICE. THE DEVICE-A 42X38X250 BEGAN TO TRAVERSE THE VERY TORTUOUS ANATOMY BUT BECAME INCREASINGLY HARD TO ADVANCE AND THE PHYSICIAN NOTICED THAT JUST DISTAL TO WHERE THE GRAFT IS LOADED INTO THE DELIVERY SYSTEM A KINK HAD FORMED ON THE DELIVERY SYSTEM. WE TRIED TO ADVANCE THE SYSTEM AGAIN WITH SOME EXTERNAL MANUAL PRESSURE BUT THE SYSTEM WOULD NOT ADVANCE. THE DEVICE WAS REMOVED AND NO DROP IN BLOOD PRESSURE WAS OBSERVED. THE PHYSICIAN THEN INSERTED A 26FR SHEATH TO TRY AND HELP THE DEVICE GET DELIVERED. THE SHEATH WENT UP. THE GRAFT WAS THEN RE-INSERTED AND NO ISSUE OF TRACKABILITY WAS OBSERVED HOWEVER AS THE DEVICE TRAVERSED UP THE DESCENDING AORTA THE ANESTHESIOLOGIST NOTICED THAT THE PTS PRESSURE HAD DROPPED. WE IMMEDIATELY OPENED THE FLUIDS, PULLED THE GRAFT OUT AND STARTED TO TAKE PICTURES. WE THEN SAW EXTRAVIZATION BACK AROUND BEHIND THE GRAFT. THE PHYSICIAN THEN DECIDED TO OPEN AFTER TRYING TO CLOSE IT OFF WITH A CUFF AND AFTER MUCH DISSECTING AND REPAIR IT WAS FOUND THAT THERE WAS A HOLE ACTUALLY IN THE DISTAL AORTA BUT NOT IN THE ENDOGRAFT. IT WAS THEREFORE ASSUMED THAT EITHER ALL THE MANIPULATION OR SHEATH PLACEMENT OR A COMBO OF BOTH CAUSED THE NATIVE AORTA TO TEAR. THE PATIENT SUBSEQUENTLY DIED." PATIENT OUTCOME: "THE PATIENT HAS DIED. I WAS INFORMED ON 2/19/2019 AT APPROX. 7:40PM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208722 RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM STENT, ENDOVASCUALR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. 170915112

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death| R