BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TREO ABDOMINAL STENT-GRAFT SYSTEM

    MDR report key: 20091642 · Received August 28, 2024

    Report

    Report Number
    2247858-2024-00219
    Event Type
    Injury
    Date Received
    August 28, 2024
    Date of Event
    April 12, 2024
    Report Date
    August 28, 2024
    Manufacturer
    BOLTON MEDICAL, INC.
    Product Code
    MIH
    PMA / PMN Number
    P190015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT WAS INVOLVED WITH THREE DEVICES. DEVICE 1 IS BEING REPORTED UNDER MDR-2247858-2024-00216, DEVICE 2 IS BEING REPORTED UNDER MDR-2247858-2024-00117, DEVICE 3 IS BEING REPORTED UNDER MDR-2247858-2024-00118, AND DEVICE 4 IS BEING REPORTED UNDER MDR-2247858-2024-00119. 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. 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

    "THE CORE LAB SENT NOTIFICATION OF A SIGNIFICANT FINDING FOR SUBJECT TPA-013-005 ON 30JUL2024 REGARDING A >5MM INCREASE SAC ENLARGEMENT FOR 3-YEAR CT IMAGING DATED (B)(6) 2024 AS COMPARED TO THE 30-DAY IMAGING. UPDATE 20AUG2024: THE CT DATED (B)(6) 2024 MEASURED MAX DIAMETER AT 71MM WITH LUMBAR ENDOLEAK ON DELAYED PHASE, LIKELY BEING FED BY BOTH RIGHT AND LEFT SIDES. AS COMPARED TO THE 30-DAY CT DATED (B)(6) 2021 WITH MAX DIAMETER OF 61MM, THEREFORE ALSO REFLECTING A >5MM INCREASE (10MM INCREASE TOTAL). THE INVESTIGATOR ASSESSMENT ALSO COINCIDES SIMILARLY BETWEEN BOTH FOLLOW-UPS. THE 3-YEAR FOLLOW-UP ON 16APR2024 NOTED THAT THE INCREASE IS LIKELY DUE TO TYPE II ENDOLEAK. ON (B)(6) 2024, THE SUBJECT UNDERWENT RE-INTERVENTION WITH COIL EMBOLIZATION OF THE RIGHT L4 LUMBAR ARTERY (THREE COILS), RIGHT LUMBAR COLLATERALS (TWO COILS), ILIOSACRAL (LEFT) ARTERY (TWO COILS), AND LEFT LUMBAR COLLATERALS (ONE COIL)." PATIENT OUTCOME: "UPDATE (B)(6) 2024: THE SUBJECT WAS DISCHARGED SAME-DAY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1478741 TREO ABDOMINAL STENT-GRAFT SYSTEM STENT, ENDOVASCULAR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. 2007160141

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Male Required Intervention