BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TREO ABDOMINAL STENT-GRAFT SYSTEM

    MDR report key: 17776117 · Received September 19, 2023

    Report

    Report Number
    2247858-2023-00247
    Event Type
    Injury
    Date Received
    September 19, 2023
    Date of Event
    August 8, 2023
    Report Date
    December 28, 2023
    Manufacturer
    BOLTON MEDICAL, INC.
    Product Code
    MIH
    PMA / PMN Number
    P190015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT WAS INVOLVED WITH THREE DEVICES. DEVICE 1 IS BEING REPORTED UNDER MDR 2247858-2023-00246, AND DEVICE 3 IS BEING REPORTED UNDER MDR 2247858-2023-00248. 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

    "UNDERWENT ELECTIVE REPAIR OF AAA, FUSIFORM SHAPE USING A TREO STENT GRAFT ON (B)(6) 2023. AT THE END OF THE PROCEDURE, IT WAS REPORTED THAT A TYPE IB ENDOLEAK ON THE RIGHT SIDE (28-L2-13-100S, B230213250) WAS CORRECTED WITH BALLOON ANGIOPLASTY. NO DEVICE DEFICIENCIES WERE REPORTED AND THE DEVICE ASSESSMENT AT THE END OF PROCEDURE WAS REPORTED BY THE SITE AS BEING ACCEPTABLE. THE INVESTIGATOR REPORTED THE EVENT AS RELATED TO PROCEDURE AND RELATED TO THE ILIAC LIMB OF THE DEVICE. THE ENDOLEAK WAS CORRECTED WITH "PTA BALLOON ANGIOPLASTY DURING INDEX PROCEDURE WITH CODA BALLOON" PATIENT' RELEVANT MEDICAL CONDITION: FUSIFORM AORTIC ANEURYSM, HYPERTENSION, HYPERCHOLESTEROLEMIA (UNKNOWN START DATES) (B)(6) 2019: DIVERTICULOSIS. (B)(6) 2016: TRANSURETHRAL RESECTION PROSTATE. ASA GRADE II - MILD SYSTEMIC DISEASE" PATIENT OUTCOME - "THE EVENT REMAINS ONGOING, BUT THE PATIENT WAS DISCHARGED ON POD01 TO THEIR NORMAL LIVING CONDITION."

    Description of Event or Problem · 0

    "UNDERWENT ELECTIVE REPAIR OF AAA, FUSIFORM SHAPE USING A TREO STENT GRAFT ON (B)(6) 2023. AT THE END OF THE PROCEDURE, IT WAS REPORTED THAT A TYPE IB ENDOLEAK ON THE RIGHT SIDE (28-L2-13-100S, B230213250) WAS CORRECTED WITH BALLOON ANGIOPLASTY. NO DEVICE DEFICIENCIES WERE REPORTED AND THE DEVICE ASSESSMENT AT THE END OF PROCEDURE WAS REPORTED BY THE SITE AS BEING ACCEPTABLE. THE INVESTIGATOR REPORTED THE EVENT AS RELATED TO PROCEDURE AND RELATED TO THE ILIAC LIMB OF THE DEVICE. THE ENDOLEAK WAS CORRECTED WITH "PTA BALLOON ANGIOPLASTY DURING INDEX PROCEDURE WITH CODA BALLOON." PATIENT OUTCOME - "THE EVENT REMAINS ONGOING, BUT THE PATIENT WAS DISCHARGED ON POD01 TO THEIR NORMAL LIVING CONDITION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1446485 TREO ABDOMINAL STENT-GRAFT SYSTEM STENT, ENDOVASCULAR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. B210115297

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Male Other