BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREO ABDOMINAL STENT-GRAFT SYSTEM

    MDR report key: 16435610 · Received February 24, 2023

    Report

    Report Number
    2247858-2023-00054
    Event Type
    Malfunction
    Date Received
    February 24, 2023
    Date of Event
    January 26, 2023
    Report Date
    July 12, 2023
    Manufacturer
    BOLTON MEDICAL, INC.
    Product Code
    MIH
    PMA / PMN Number
    P190015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT WAS INVOLVED WITH FOUR DEVICES. DEVICE 1 IS BEING REPORTED UNDER MDR-2247858-2023-00053, DEVICE 3 IS BEING REPORTED UNDER MDR-2247858-2023-00055, AND DEVICE 4 IS BEING REPORTED UNDER MDR-2247858-2023-00056.

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT WAS INVOLVED WITH FOUR DEVICES. DEVICE 1 IS BEING REPORTED UNDER MDR-2247858-2023-00053, DEVICE 2 IS BEING REPORTED UNDER MDR-2247858-2023-00054, DEVICE 3 IS BEING REPORTED UNDER MDR-2247858-2023-00055, AND DEVICE 4 IS BEING REPORTED UNDER MDR-2247858-2023-00056. BOLTON MEDICAL, INC. (D/B/A TERUMO AORTIC), HEREIN KNOWN AS THE "COMPANY", IS SUBMITTING THIS REPORT PURSUANT TO 21 CFR PART 803, HAS MADE REASONABLE EFFORTS TO OBTAIN COMPLETE INFORMATION, AND HAS PROVIDED AS MUCH AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT IS BASED ON INFORMATION OBTAINED BY THE COMPANY, WHICH MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE REGULATIONS. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN, UNAVAILABLE, OR NOT APPLICABLE. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY ANYONE THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE A LEGAL ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY DEFECTS OR HAS MALFUNCTIONED, AS DEFINED FROM A LEGAL STANDPOINT. THESE WORDS ARE INCLUDED IN THE REPORT AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE CERTAIN REGULATIONS, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Description of Event or Problem · 0

    PATIENT PRESENTED THE NEXT LATE AFTERNOON WITH WHAT APPEARED TO BE CONTINUOUS FILLING OF THE ANEURYSMAL SAC AND SOME POSSIBLE CLAUDICATION. UPON REVIEW FROM CAT SCAN, IT WAS DETERMINED THAT DUE TO MOVEMENT DURING IMPLANTATION OF THE MAIN BODY AND NO DISTAL MARKERS OF THE IPSILATERAL LIMB THAT LIMB WAS CANNULATED INADVERTENTLY TWICE. THEREFORE, THE CONTRALATERAL LIMB DID NOT HAVE AN EXTENSION AND THE IPSILATERAL HAD BOTH LIMB EXTENSIONS. PATIENT OUTCOME - "PATIENT WAS NOT INJURED. WE INTERVENED AGAIN LATER FRIDAY THE 28TH. LATE AFTERNOON INTO EVENING. PRIOR TO INTERVENING TO REPAIR THE DOCTORS FILLED THE SACK WITH MANY PENUMBRA COILS. THEN, AT THAT POINT, WE USED AN AMPLATZER PLUG TO SHUT DOWN THE CONTRALATERAL GATE AT THE BIFURCATION. THEN WE EXTENDED 2 -8MM X 59 GORE VBX COVERED STENTS FROM THE IPSI LATERAL LIMB INTO THE LEFT AND RIGHT ILIAC ARTERIES."

    Description of Event or Problem · 0

    PATIENT PRESENTED THE NEXT LATE AFTERNOON WITH WHAT APPEARED TO BE CONTINUOUS FILLING OF THE ANEURYSMAL SAC AND SOME POSSIBLE CLAUDICATION. UPON REVIEW FROM CAT SCAN, IT WAS DETERMINED THAT DUE TO MOVEMENT DURING IMPLANTATION OF THE MAIN BODY AND NO DISTAL MARKERS OF THE IPSILATERAL LIMB THAT LIMB WAS CANNULATED INADVERTENTLY TWICE. THEREFORE, THE CONTRALATERAL LIMB DID NOT HAVE AN EXTENSION AND THE IPSILATERAL HAD BOTH LIMB EXTENSIONS. PATIENT OUTCOME - "PATIENT WAS NOT INJURED. WE INTERVENED AGAIN LATER FRIDAY (B)(6). LATE AFTERNOON INTO EVENING. PRIOR TO INTERVENING TO REPAIR THE DOCTORS FILLED THE SACK WITH MANY PENUMBRA COILS. THEN, AT THAT POINT, WE USED AN AMPLATZER PLUG TO SHUT DOWN THE CONTRALATERAL GATE AT THE BIFURCATION. THEN WE EXTENDED 2 -8MM X 59 GORE VBX COVERED STENTS FROM THE IPSI LATERAL LIMB INTO THE LEFT AND RIGHT ILIAC ARTERIES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2022845 TREO ABDOMINAL STENT-GRAFT SYSTEM STENT, ENDOVASCULAR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. 2009080276

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Required Intervention