BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II

    MDR report key: 3100638 · Received May 8, 2013

    Report

    Report Number
    2953200-2013-00861
    Event Type
    Injury
    Date Received
    May 8, 2013
    Date of Event
    April 17, 2013
    Report Date
    April 17, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4), RESULTS: INHERENT RISK OF PROCEDURE (GENITOURINARY COMPLICATIONS). CONCLUSION: KNOWN INHERENT RISK OF A PROCEDURE (GENITOURINARY COMPLICATIONS).

    Description of Event or Problem · 1

    AN ENDURANT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY WERE NOT REPORTED. IT WAS REPORTED THAT THE PATIENT DEVELOPED AN ISSUE WITH THEIR TESTICLE ON THE RIGHT SIDE WHERE IT WAS FOUND TO HAVE INFARCTED. UROLOGY PERFORMED AN EXPLORATORY SURGERY AND DECIDED TO REMOVE THE TESTICLE. THE CAUSE OF THE INFARCT WAS THE RIGHT HYPOGASTRIC ARTERY (CONTRALATERAL SIDE) WAS PARTIALLY OCCLUDED. AT THE TIME OF IMPLANT THE STENT GRAFT WAS NOT OCCLUDING THE HYPOGASTRIC ARTERY AND EVENTUALLY GOT OCCLUDED AND LIKELY LED TO THE INFARCT. THE PATIENT DID NOT HAVE COAGULATION ISSUES. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201879 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V03987884

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Required Intervention