BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREO ABDOMINAL STENT-GRAFT SYSTEM

    MDR report key: 10268585 · Received July 13, 2020

    Report

    Report Number
    2247858-2020-00035
    Event Type
    Malfunction
    Date Received
    July 13, 2020
    Date of Event
    June 19, 2020
    Report Date
    September 11, 2020
    Manufacturer
    BOLTON MEDICAL, INC.
    Product Code
    MIH
    PMA / PMN Number
    P190015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    "THE PATIENT HAD TORTUOUS ILIAC ACCESS. INITIALLY THE PHYSICIAN TRIED TO PLACE THE MAIN BODY UP THE RIGHT COMMON FEMORAL AND IT WOULD NOT PASS BEYOND A KNOWN CALCIFIC STENOSIS IN THE RIGHT COMMON ILIAC. THE PHYSICIAN THEN PUT THE DEVICE UP THE LEFT COMMON FEMORAL AND IT ADVANCED TO THE DESIRED LOCATION NEAR THE RENAL ARTERIES. HE THEN STARTED DEPLOYMENT OF THE GRAFT PER IFU. THE CONTRALATERAL GATE WAS UNCOVERED, AND THE PHYSICIAN PROCEEDED TO UNCLASP THE PROXIMAL CLASP. HE A LITTLE DIFFICULTY WITH THE GREY RELEASE RETAINER AND I REMINDED HIM AGAIN THAT IT WAS A PUSH IN THEN TWIST. WE WERE ABLE TO THE MOVE THE GREY RELEASE RETAINER AND PULL THE BLACK PROXIMAL CLASP HOLDER BACK. UNDER FLOURO THE CLASP MOVED BACK BUT IT APPEARED THAT THE SUPRARENAL STENT DID NOT DISENGAGE FROM THE APEX HOLDER. WE CONTINUED WITH THE PROCEDURE BY CANNULATING THE CONTRALATERAL GATE AND DEPLOYING THE CONTRALATERAL LIMB. THAT PROCESS WAS UNEVENTFUL. WE THEN PROCEEDED WITH THE DEPLOYMENT OF THE IPSILATERAL GATE. ONCE THE CATHETER WAS FREE FROM THE CONTRALATERAL GATE WE TRIED TO MOVE THE CATHETER AND NOTED THAT IT WAS STILL CONSTRAINED PROXIMALLY. THE PHYSICIAN TRIED TO MOVE THE CATHETER AND THE SUPRARENAL STENTS WERE MOVING. I HAD HIM GENTLY TWIST THE CATHETER AND YOU COULD SEE THE SUPRARENAL STENTS DISENGAGING, ONE BY ONE, FROM THE APEX HOLDER. WE THEN REMOVED THE DEVICE AND IMPLANTED THE IPSILATERAL LIMB." PATIENT OUTCOME: "(B)(6) SPOKE TO THE PHYSICIAN THE MORNING OF (B)(6) 2020 AND SHE IS DOING WELL ACCORDING TO DR. (B)(6). HE SAID SHE SHOULD BE RELEASED FROM THE HOSPITAL TOMORROW. "

    Additional Manufacturer Narrative · 1

    THE TREO ABDOMINAL STENT GRAFT SYSTEM RECEIVED FDA APPROVAL FOR SALE IN THE US ON MAY 4, 2020 (P190015).

    Description of Event or Problem · 1

    "THE PATIENT HAD TORTUOUS ILIAC ACCESS. INITIALLY THE PHYSICIAN TRIED TO PLACE THE MAIN BODY UP THE RIGHT COMMON FEMORAL AND IT WOULD NOT PASS BEYOND A KNOWN CALCIFIC STENOSIS IN THE RIGHT COMMON ILIAC. THE PHYSICIAN THEN PUT THE DEVICE UP THE LEFT COMMON FEMORAL AND IT ADVANCED TO THE DESIRED LOCATION NEAR THE RENAL ARTERIES. HE THEN STARTED DEPLOYMENT OF THE GRAFT PER IFU. THE CONTRALATERAL GATE WAS UNCOVERED, AND THE PHYSICIAN PROCEEDED TO UNCLASP THE PROXIMAL CLASP. HE A LITTLE DIFFICULTY WITH THE GREY RELEASE RETAINER AND I REMINDED HIM AGAIN THAT IT WAS A PUSH IN THEN TWIST. WE WERE ABLE TO THE MOVE THE GREY RELEASE RETAINER AND PULL THE BLACK PROXIMAL CLASP HOLDER BACK. UNDER FLOURO THE CLASP MOVED BACK BUT IT APPEARED THAT THE SUPRARENAL STENT DID NOT DISENGAGE FROM THE APEX HOLDER. WE CONTINUED WITH THE PROCEDURE BY CANNULATING THE CONTRALATERAL GATE AND DEPLOYING THE CONTRALATERAL LIMB. THAT PROCESS WAS UNEVENTFUL. WE THEN PROCEEDED WITH THE DEPLOYMENT OF THE IPSILATERAL GATE. ONCE THE CATHETER WAS FREE FROM THE CONTRALATERAL GATE WE TRIED TO MOVE THE CATHETER AND NOTED THAT IT WAS STILL CONSTRAINED PROXIMALLY. THE PHYSICIAN TRIED TO MOVE THE CATHETER AND THE SUPRARENAL STENTS WERE MOVING. I HAD HIM GENTLY TWIST THE CATHETER AND YOU COULD SEE THE SUPRARENAL STENTS DISENGAGING, ONE BY ONE, FROM THE APEX HOLDER. WE THEN REMOVED THE DEVICE AND IMPLANTED THE IPSILATERAL LIMB." PATIENT OUTCOME: "(B)(6) SPOKE TO THE PHYSICIAN THE MORNING OF (B)(6) 2020 AND SHE IS DOING WELL ACCORDING TO DR. FOTEH. HE SAID SHE SHOULD BE RELEASED FROM THE HOSPITAL TOMORROW. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732926 TREO ABDOMINAL STENT-GRAFT SYSTEM STENT, ENDOVASCUALR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. 2006020088

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR