BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT

    MDR report key: 4232969 · Received November 6, 2014

    Report

    Report Number
    2953200-2014-02337
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    October 27, 2014
    Report Date
    October 27, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A 5.0 CM DIAMETER ABDOMINAL AORTIC ANEURYSM ON. THE AORTA AT THE RENAL ARTERY WAS 21 MM AT IMPLANT. THE LENGTH OF THE PROXIMAL NECK WAS 30 MM AT IMPLANT. THE DEGREE OF ANGULATION, VESSEL TORTUOSITY, AND CALCIFICATION WERE BOTH NOTED AS MINIMAL AT IMPLANT. THERE WAS NO PRE-OPERATIVE ANEURYSM RUPTURE. IT WAS REPORTED THAT AFTER UNSHEATHING THE DEVICE AND BEFORE DEPLOYMENT OF THE SUPRA-RENAL STENT, BLEEDING OCCURRED IN THE GROIN. MANIPULATION WITHIN THE GROIN MOST LIKELY ADVANCED THE DELIVERY SYSTEM 2-3 MM. THIS LAID THE PROXIMAL GRAFT IN THE LEFT RENAL ARTERY. THE PHYSICIAN DECIDED TO DEPLOY A STENT INTO THE LEFT RENAL ARTERY TO KEEP PATENCY. IT WAS NOTED THAT THE EVENT WAS RELATED TO THE PROCEDURE AND HAD BEEN RESOLVED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715205 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04670201

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Required Intervention