BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II STENT GRAFT

    MDR report key: 12834742 · Received November 18, 2021

    Report

    Report Number
    9612164-2021-04473
    Event Type
    Injury
    Date Received
    November 18, 2021
    Date of Event
    February 3, 2021
    Report Date
    November 18, 2021
    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 OBTAINED FROM THE JOURNAL ARTICLE ENTITLED; COMPARISON OF OUTCOMES FOLLOWING EVAR BASED ON ANEURYSM DIAMETER AND VOLUME AND THEIR POSTOPERATIVE VARIATIONS MONTELIONE ET AL, ANN VASC SURG VOLUME 74, P183-193, JULY 01, 2021 HTTPS://DOI.ORG/10.1016/J.AVSG.2020.12.048. EXACT DATE OF IMPLANT UNKNOWN. THE MORTALITY RATES WERE 7.2% HOWEVER THERE WAS NO INFORMATION TO SUGGEST ANY OF THE ENDURANT DEVICE FAILURES CAUSED OR CONTRIBUTED TO THE DEATHS. THERE WAS NO INFORMATION TO SUGGEST ANY ENDURANT 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 OR VIGILANCE 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 AND ENDURANT II STENT GRAFT SYSTEMS WERE IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF ABDOMINAL AORTIC ANEURYSMS ON UNKNOWN DATES. THE FOLLOWING ADVERSE EVENTS WERE REPORTED REINTERVENTION, FEMORAL PSEUDOANEURYSM, PARTIAL RENAL OCCLUSION, LIMBS OCCLUSION, RTBAD AND LIMB STENOSIS. THE CAUSE OF THE ADVERSE EVENTS ARE UNDETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1736609 ENDURANT II STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR MIH MEDTRONIC IRELAND UNK-CV-SR-ENDUR-II

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Required Intervention