BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT STENT GRAFT

    MDR report key: 14427588 · Received May 18, 2022

    Report

    Report Number
    9612164-2022-01865
    Event Type
    Injury
    Date Received
    May 18, 2022
    Date of Event
    November 13, 2021
    Report Date
    May 17, 2022
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION FROM A JOURNAL ARTICLE ENTITLED; CO2 AUTOMATED ANGIOGRAPHY IN ENDOVASCULAR AORTIC REPAIR PRESERVES RENAL FUNCTION TO A GREATER EXTENT COMPARED WITH IODINATED CONTRAST MEDIUM. ANALYSIS OF TECHNICAL AND ANATOMICAL DETAILS VACIRCA ET AL, ANN VASC SURG 2022; 81: 79¿88. HTTPS://DOI.ORG/10.1016/J.AVSG.2021.10.039. MEAN AGE. MEAN GENDER. EXACT DATE OF IMPLANT UNKNOWN THERE WAS NO INFORMATION TO SUGGEST ANY MEDTRONIC DEVICE FAILURE CAUSED OR CONTRIBUTED TO A DEATH. DEATHS ARE COMMON OCCURRENCES HOWEVER THE CAUSE(S) OF DEATH ARE OFTEN NOT CHARACTERIZED OR CLEARLY ASSOCIATED WITH A PARTICULAR PRODUCT. THEREFORE, DEATHS WILL NOT BE CONSIDERED REPORTABLE AS MDR UNLESS CLEARLY STATED AS BEING ASSOCIATED WITH MEDTRONIC PRODUCT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ENDURANT STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF ABDOMINAL AORTIC ANEURYSMS ON UNKNOWN DATES. NON MDT STENT GRAFTS WERE ALSO IMPLANTED. THE FOLLOWING ADVERSE EVENTS WERE REPORTED: RENAL FAILURE AND DEATH. THERE WAS NO INFORMATION TO SUGGEST ANY MEDTRONIC DEVICE FAILURE CAUSED OR CONTRIBUTED TO A DEATH. THE CAUSE OF RENAL FAILURE IS UNDETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2753534 ENDURANT STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR MIH MEDTRONIC IRELAND UNK-CV-SR-ENDURANT

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Other