BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELAY THORACIC STENT-GRAFT/PLUS DELIVERY SYST

    MDR report key: 3875143 · Received May 13, 2014

    Report

    Report Number
    2247858-2014-00005
    Event Type
    Injury
    Date Received
    May 13, 2014
    Date of Event
    March 27, 2014
    Report Date
    May 13, 2014
    Manufacturer
    BOLTON MEDICAL, INC.
    Product Code
    MIH
    PMA / PMN Number
    P110038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RETURNED UNIT INVESTIGATION: THIS DELIVERY SYSTEM WAS NOT RETURNED FOR EXAMINATION. BASED ON THE MANUFACTURING RECORDS, THERE WERE NO MANUFACTURING ISSUES DURING THE ASSEMBLY PROCESS OF THIS UNIT. FURTHERMORE, PER THE NARRATIVE, APPEARS THAT THE PARAPLEGIA OBSERVED WAS NOT CAUSED DIRECTLY BY OUR DEVICE, BUT RATHER AS A SIDE EFFECT OF THE PROCEDURE. NO ADDITIONAL INVESTIGATION CAN BE PERFORMED FOR THIS CASE. PARAPLEGIA IS A KNOWN ADVERSE EVENT OF TEVAR PROCEDURES, AS INDICATED IN THE IFU. RECENT STUDIES 1,2 HAVE AIMED TO UNDERSTAND THE RISKS FACTORS THAT COULD LEAD, TO SPINAL CORD ISCHEMIA AFTER A TEVAR PROCEDURE. A TABLE SUMMARIZING THESE POTENTIALLY RELEVANT POINTS IS SUMMARIZED BELOW. THESE POINTS WILL CONTINUE TO BE MONITORED TO DETERMINE ANY TRENDS. CONCLUSION: BASED ON THE NARRATIVE, IT DOES NOT APPEAR THAT THE PARAPLEGIA WAS CAUSED SPECIFICALLY BY BOLTON'S DEVICE MOREOVER, PARAPLEGIA IS A KNOWN ADVERSE EFFECT OF TEVAR PROCEDURES. REPORTED TO BOLTON MEDICAL BY (B)(6).

    Description of Event or Problem · 1

    CASE REPORT FROM (B)(6) REPORTED AS "ON (B)(6) 2014, THE DEVICE WAS USED FOR THE CASE OF TYPE B DISSECTION STARTED JUST BELOW THE LEFT SUBCLAVIAN ARTERY. THE ENTRY OF DISSECTION LAY NEAR THE CELIAC ARTERY. AFTER MEASURING, SIZE 28/24-195 RELAY PLUS WAS IMPLANTED IN DESCENDING AORTA - 1 TO 1.5CM ABOVE THE LEFT CELIAC ARTERY - BY APPROACHING FROM THE RIGHT COMMON FEMORAL ARTERY. SUBSEQUENTLY, SIZE 32/28-200 COOK TX2 WAS IMPLANTED. ALTHOUGH THE DOCTOR WAS INTENDED TO IMPLANT THE LEFT JUST BELOW THE LEFT COMMON CAROTID ARTERY, THE GRAFT WAS ACTUALLY IMPLANTED A LITTLE LOWER THAN THE INTENDED SITE. BY ANGIOGRAPHY, TYPE 1A ENDOLEAK WAS FOUND ON THE STENT GRAFT IMPLANTED PROXIMAL, SO 32MM - PROXIMAL EXTENSION COOK TX2 WAS ADDITIONALLY IMPLANTED AND EXTENDED BY 40MM- CODA BALLOON. BEING CONFIRMED THAT THE ENDOLEAK WAS DISAPPEARED, THE DOCTOR OCCLUDED THE LEFT SUBCLAVIAN ARTERY AND THE PROCEDURE WAS SUCCESSFULLY DONE. ON THE SAME DAY AFTER PROCEDURE, THE PT MOVED A LIMB REGARDLESS OF BEING REQUIRED A REST." "ON (B)(6) 2014, THE PT COULD NOT URINATE SPONTANEOUSLY UNTIL AROUND NOON. THE URETERAL CATHETER WAS INSERTED IN THE PT, AND 500ML OF URINE WAS CONFIRMED. IT WAS OBSERVED THAT THE RIGHT LEG OF THE PT HARDLY MOVED AND LEFT LEG DIDN'T MOVE AT ALL. BY CT, THE DOCTOR CONFIRMED THAT PARAPLEGIA WAS CAUSED BY SPINAL CORD INFARCTION AT TH11 AND BELOW." DOCTOR'S COMMENT: "PARAPLEGIA WAS A POSSIBLE RISK BECAUSE SEVERAL STENT GRAFTS WERE IMPLANTED OVER A WIDE RANGE EXTENDED TO TH11 AREA WHERE THE INTERCOSTAL ARTERY OF THIS PT WAS BRANCHED OFF. IT CAN'T BE IDENTIFIED, BUT THE FACT THAT THE PT MOVED HIS LEGS ON THE DAY OF PROCEDURE WAS LIKELY TO CONTRIBUTE TO PARAPLEGIA."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285400 RELAY THORACIC STENT-GRAFT/PLUS DELIVERY SYST STENT, ENDOVASCULAR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. 140204139

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability