BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM

    MDR report key: 9290691 · Received November 7, 2019

    Report

    Report Number
    2247858-2019-00075
    Event Type
    Injury
    Date Received
    November 7, 2019
    Date of Event
    October 9, 2019
    Report Date
    November 7, 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

    Description of Event or Problem · 1

    "BARE STENT CAME OFF FROM PROXIMAL CLASP: THE PROCEDURE OF TEVAR WAS PERFORMED FOR A TYPE B AORTIC DISSECTION, WHERE WAS AROUND THE DISTAL SIDE AT 3CM BENEATH THE LEFT CLAVICLE. THE AORTA BENT AND WAS VERY NARROW AT THE LEVEL OF THE DIAPHRAGM. THE PHYSICIAN PUSHED THE INNER SHEATH OUT OF THE OUTER SHEATH BEFORE THE BEND AND MANAGED TO DELIVER THE DEVICE. THEN, THE PHYSICIAN DEPLOYED THE RELAY PLUS (28-M3 32 200 28 23 90U, AU-3220028, LOT#170405077). ACCORDING TO ANGIOGRAPHY, THE ENTRY WAS COVERED BUT THE DISTAL END OF THE AORTA SEEMED INJURED. IN ORDER TO DEAL WITH THE INJURY, THE PHYSICIAN DECIDED TO ADD ANOTHER RELAY PLUS (28-M3 30 200 26 23 90U, AU-3020026, LOT#1905080100) AT THE DISTAL END. SAME AS THE FIRST DEVICE, THE PHYSICIAN PUSHED THE INNER SHEATH OUT OF THE OUTER SHEATH AND ATTEMPTED TO DELIVER THE DEVICE. WHEN THE TIP OF THE SECOND DEVICE WENT INTO THE FIRST DEVICE, THE PHYSICIAN COULD NOT ADVANCE THE SECOND DEVICE. THE PHYSICIAN ATTEMPTED TO PUSH THE SECOND DEVICE FORWARD BUT THE OUTCOME WAS THE SAME. THE PHYSICIAN WITHDREW THE INNER SHEATH BACK IN THE OUTER SHEATH AND REMOVED THE DEVICE OUT OF THE PATIENT SLOWLY AND CAREFULLY. THE PHYSICIAN OBSERVED THAT ONE OF THE BARE STENTS CAME OFF FROM THE PROXIMAL CLASP. THE PHYSICIAN DECIDED TO REPLACE THE DEVICE WITH ANOTHER DEVICE (28-M3 32 200 28 23 90U, AU-3220028, LOT#1906180082) TO CONTINUE THE PROCEDURE. WITH THE PULL-THROUGH TECHNIQUE, THE PHYSICIAN SUCCESSFULLY DEPLOYED THE THIRD DEVICE AT THE DISTAL END AND ANGIOGRAPHY CONFIRMED THAT THE PROCEDURE WAS COMPLETED. THE PHYSICIAN WOULD LIKE TO KNOW IF THERE IS ANY POSSIBILITY OF A BARE STENT COMING OFF FROM A PROXIMAL CLASP DURING DELIVERY. " PATIENT OUTCOME: "THE POSTOPERATIVE COURSE IS UNEVENTFUL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1084687 RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM STENT, ENDOVASCUALR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. 1905080100

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other| R