BEUDAMED
    FDA Adverse Event Death Summary report: N

    RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM

    MDR report key: 7319036 · Received March 6, 2018

    Report

    Report Number
    2247858-2018-00030
    Event Type
    Death
    Date Received
    March 6, 2018
    Date of Event
    October 8, 2014
    Report Date
    March 6, 2018
    Manufacturer
    BOLTON MEDICAL, INC.
    Product Code
    MIH
    PMA / PMN Number
    P110038
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    "DURING AN INTERNAL AUDIT, IT WAS DETERMINED THAT COMPLAINTS FOR SIMILAR DEVICES, AND DEVICE MALFUNCTIONS THAT HAVE THE POTENTIAL TO HARM THE PATIENT IF THEY WERE TO RECUR, WERE NOT REPORTED AS PER FDA GUIDANCE. AFTER RETROSPECTIVE REVIEW, THIS EVENT IS DETERMINED TO BE MDR REPORTABLE." "BOLTON MEDICAL IS VOLUNTARILY REPORTING A DEVICE MALFUNCTION RELATED TO THE RELAY THORACIC STENT GRAFT WITH PLUS DELIVERY SYSTEM (THE RELAY CUSTOM SYSTEM). THE RELAY CUSTOM SYSTEM IS NOT MARKETED IN THE US, HOWEVER IT IS SIMILAR TO THE RELAY THORACIC STENT GRAFT WITH PLUS DELIVERY SYSTEM APPROVED FOR SALE IN THE US IN 2012 (P110038).

    Description of Event or Problem · 1

    "THE PATIENT HAD A CHRONIC DISSECTION WHICH BECAME SYMPTOMATIC WITH SEVERE PAINS A FEW DAYS AGO. THE AORTA WAS SEVERELY TORTUOUS AT THE LEVEL OF THE DIAPHRAGM. DR (B)(6) HAD DIFFICULTIES IN ADVANCING THE FIRST SYSTEM TO REACH THE PROXIMAL LANDING ZONE WHICH WAS THE LCA. THE LSA HAD BEEN TRANSPOSED JUST BEFORE. THE SECONDARY SHEATH AND PROXIMAL INTRODUCER NOSE WAS WAY BACK IN THE ARCH AFTER DR (B)(6) PUSHED FORWARD THE GREY HANDLE AGAINST THE PROXIMAL BLACK ONE.HE THEN PUSHED THE WHOLE SYSTEM UP TO REACH THE TARGET. IN DOING SO, THERE WAS A " JUMP " ON THE SCREEN AND THE BLOOD PRESSURE ALARM WENT ON. NO BP ANY MORE. RUPTURED AORTA AT THE LEVEL OF THE S CURVE. THERE WAS STILL A PULSE FOR SOME TIME AFTER THE ANESTHESIST SUPPORTED THE PATIENT. DR (B)(6) EXCLUDED THE LESION FOLLOWING THE PLAN AND DEPLOYED DISTALLY 2 OTHER RELAY PLUS.ON ANGIO CONTROL THE PATIENT WAS DECLARED DECEASED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158884 RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM STENT, ENDOVASCULAR GRAFT, AORTIC, MIH BOLTON MEDICAL, INC. B140926085

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death