BEUDAMED
    FDA Adverse Event Death Summary report: N

    RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM

    MDR report key: 6175593 · Received December 15, 2016

    Report

    Report Number
    2247858-2016-00013
    Event Type
    Death
    Date Received
    December 15, 2016
    Date of Event
    November 18, 2016
    Report Date
    December 14, 2016
    Manufacturer
    BOLTON MEDICAL, INC.
    Product Code
    MIH
    PMA / PMN Number
    P110038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT WAS INVOLVED WITH TWO DEVICES. DEVICE 1 IS BEING REPORTED UNDER THIS MDR 2247858-2016-00013 AND DEVICE 2 IS BEING REPORTED UNDER MDR 2247858-2016-00014. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    "PATIENT PRESENTED INTO THE EMERGENCY ROOM WITH CHEST PAIN, WORK UP WAS PREFORMED AND THE THORACIC ANEURYSM AND DISSECTION WAS NOTED ON PT. SEVEN CENTIMETERS (7CM) INVOLVING THE LSA WITH DISSECTION NOTED IN THE SAC. DR. (B)(6) CONSULTED WITH PATIENT ON INTERVENTION OPTION AND TRIED TO REFER THE PATIENT OUT TO A HIGH LEVEL OF CARE FACILITY. PATIENT AND FAMILY MADE THE DECISION TO STAY AT (B)(6) REGIONAL MEDICAL CENTER AND UNDERGO TREATMENT WITH KNOWN RISK. SEE SIZING SHEET AND PICTURE. DEVICE IMPLANTED AND OPENED PATIENT WAS PLACED ON THE OPERATING ROOM TABLE AT APPROXIMATELY 10 AM ON (B)(6) 2016, PREPPED AND DRAPED IN STERILE FASHION. SIX (6) FR. SHEATH PLACED INTO THE LFA, CUT DOWN PREFORMED ON RIGHT GROIN, ARTERY WAS VERY FRIABLE AND HAD TO SEW THE ARTERY PRIOR TO STARTING CASE. DR. (B)(6) HAD TROUBLE PLACING WIRE UP THRU THE ANEURYSM AND CALLED IN THE CARDIOLOGIST TO ASSIST. TOOK APPROX. 1 OR, SO TO ESTABLISH WIRE CONTROL THRU THE ANEURYSM TO ASCENDING AORTA. USED MULTIPLE WIRES, J-WIRE, WHOLELY WIRE, ANGLE GLIDE, SUPER STIFF GLIDE WIRE WITH, JR4 CATHETER, ANGLE GLIDE CATH AND MARKER PIGTAIL USED TO TRANSVERSE ANEURYSM. AFTER ESTABLISHING WIRE CONTROL, THE RELAY 22X100 GRAFT WAS PLACED AT THE OSTIUM OF THE LCA, THE ACUTE ANGLE OF THE NECK REQUIRED MANIPULATION OF DEVICE. DEVICE WAS DEPLOYED AT THE LCA AND GRAFT DELIVERY SYSTEM WAS REMOVED. DURING THE PROCESS, THE PATIENT BECAME UNSTABLE AND STARTED TO BLEED THRU THE ENDOTRACHEAL TUBE, REQUIRING BLOOD AND RECESSIVE CARE. THE SECOND GRAFT WAS OPENED 22X150 AND PLACED ON TABLE, DR. (B)(6) DECIDED TO OPEN THE 26X 150 TO ATTEMPT TO COVER FURTHER DOWN THE AORTA AND WAS PLACED INTO THE PATIENT BUT WAS NOT DEPLOYED. PATIENT TIME OF DEATH WAS CALLED AT 13:21."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829579 RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM STENT, ENDOVASCULAR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. 161114015

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Death