BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TREO ABDOMINAL STENT-GRAFT SYSTEM

    MDR report key: 10219801 · Received July 1, 2020

    Report

    Report Number
    2247858-2020-00032
    Event Type
    Injury
    Date Received
    July 1, 2020
    Date of Event
    June 12, 2020
    Report Date
    September 28, 2020
    Manufacturer
    BOLTON MEDICAL, INC.
    Product Code
    MIH
    PMA / PMN Number
    P190015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    "FIRST PART OF THE PROCEDURE WENT WITHOUT ANY PROBLEMS. AT THE MOMENT OF THE PROXIMAL RELEASE OF THE BARE STENT, THERE WAS A LOT OF RESISTANCE IN RELEASE MECHANISM. AT THIS MOMENT THE PHYSICIAN HAD TROUBLE TO PUSH THE GREY KNOB AND TURN IT. HE EXPERIENCED A LOT OF FRICTION AND USED QUITE A LOT OF FORCE TO PUSH AND TURN IT. THIS WAS ALREADY TOO DIFFICULT. AFTER HE SUCCESSFULLY TURNED THE GREY KNOB, WE CHECKED POSITION AGAIN; THIS WAS OK. THEN HE PULLED THE BLACK RELEASE GRIP TOWARDS THE FLUSHING PORT WITH NO PROBLEMS. UNDER FLUOROSCOPY WE SAW THE CLASP RETRACTING. BUT THEN ALL THE BARE SPRINGS WERE STILL CAPTURED, EVEN THOUGH THE BLACK RELEASE GRIP WAS COMPLETELY RETRACTED. WE RESOLVED THIS PROBLEM AS DESCRIBED BELOW: AS A SOLUTION WE MANUALLY KEPT THE MAIN BODY IN POSITION, CANNULATED THE CL LEG, EXCHANGED FOR A STIFF WIRE AND ADVANCED AN 12F SHEATH TOWARDS THE BARE STENT. AFTER A PUSH OF THIS 12F SHEATH ALL THE BARE SPRINGS OPENED COMPLETELY." PATIENT OUTCOME: "1A ENDOLEAK (ALSO AFTER PROXIMAL BALLOONING), BUT POSITION OF THE MAIN BODY WAS PERFECT. (DIRECTLY PLACED BELOW RIGHT RENAL ARTERY)."

    Additional Manufacturer Narrative · 1

    THE TREO ABDOMICAL STENT GRAFT SYSTEM RECEIVED FDA APPROVAL FOR SALE IN THE US ON (B)(6) 2020 (P190015).

    Description of Event or Problem · 1

    "FIRST PART OF THE PROCEDURE WENT WITHOUT ANY PROBLEMS. AT THE MOMENT OF THE PROXIMAL RELEASE OF THE BARE STENT, THERE WAS A LOT OF RESISTANCE IN RELEASE MECHANISM. AT THIS MOMENT THE PHYSICIAN HAD TROUBLE TO PUSH THE GREY KNOB AND TURN IT. HE EXPERIENCED A LOT OF FRICTION AND USED QUITE A LOT OF FORCE TO PUSH AND TURN IT. THIS WAS ALREADY TOO DIFFICULT. AFTER HE SUCCESSFULLY TURNED THE GREY KNOB, WE CHECKED POSITION AGAIN; THIS WAS OK. THEN HE PULLED THE BLACK RELEASE GRIP TOWARDS THE FLUSHING PORT WITH NO PROBLEMS. UNDER FLUOROSCOPY WE SAW THE CLASP RETRACTING. BUT THEN ALL THE BARE SPRINGS WERE STILL CAPTURED, EVEN THOUGH THE BLACK RELEASE GRIP WAS COMPLETELY RETRACTED. WE RESOLVED THIS PROBLEM AS DESCRIBED BELOW: AS A SOLUTION WE MANUALLY KEPT THE MAIN BODY IN POSITION, CANNULATED THE CL LEG, EXCHANGED FOR A STIFF WIRE AND ADVANCED AN 12F SHEATH TOWARDS THE BARE STENT. AFTER A PUSH OF THIS 12F SHEATH ALL THE BARE SPRINGS OPENED COMPLETELY." PATIENT OUTCOME: "1A ENDOLEAK (ALSO AFTER PROXIMAL BALLOONING), BUT POSITION OF THE MAIN BODY WAS PERFECT. (DIRECTLY PLACED BELOW RIGHT RENAL ARTERY)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681757 TREO ABDOMINAL STENT-GRAFT SYSTEM STENT, ENDOVASCUALR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. B200117243

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other