BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK-CV-SR

    MDR report key: 19257739 · Received May 7, 2024

    Report

    Report Number
    9612164-2024-02148
    Event Type
    Injury
    Date Received
    May 7, 2024
    Date of Event
    October 4, 2023
    Report Date
    May 7, 2024
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM A JOURNAL ARTICLE ENTITLED; DISPARITIES IN OUTCOMES BETWEEN SEXES IN TYPE B AORTIC DISSECTION PATIENTS TREATED WITH TEVAR YAMMINE H, BRIGGS CS, FREDERICK JR, STANLEY G, CRESPO SOTO H, NUSSBAUM T, MADJAROV JM, ARKO FR 3RD. ANNALS OF  VASCULAR  SURGERY. 2024 FEB;99:223-232.  DOI: 10.1016/J.AVSG.2023.08.012 EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. A2. <(>&<)> A3.B AVERAGE VALUES USED  MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    MEDTRONIC AND NON MDT STENT GRAFTS WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF TYPE B AORTIC DISSECTION OVER A 5 YEAR PERIOD. THE AIM OF THE STUDY TO  WAS EVALUATE DIFFERENCES IN PRESENTATION AND OUTCOMES BETWEEN SEXES IN PATIENTS. 186 PATIENTS WERE INCLUDED IN THE STUDY OF WHICH 112 IDENTIFIED AS A MALE GENDER.  THE FOLLOWING SERIOUS INJURIES WERE REPORTED;  STROKE, ACUTE KIDNEY INJURY, RTAD, RE-INTERVENTION  PATIENT MORTALITY WAS REPORTED BUT THERE IS NO CAUSAL LINK THAT A MDT STENT GRAFT CAUSED OR CONTRIBUTED TO ANY DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380898 UNK-CV-SR SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR MIH MEDTRONIC IRELAND UNK-CV-SR

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Unknown Required Intervention| O