BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT

    MDR report key: 4210381 · Received October 29, 2014

    Report

    Report Number
    2953200-2014-02222
    Event Type
    Injury
    Date Received
    October 29, 2014
    Date of Event
    October 3, 2014
    Report Date
    October 3, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY AT TIME OF IMPLANT ARE UNKNOWN. IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH BELLY PAIN AND UPON CT SCAN IT APPEARED AS IF THERE MAY BE AN INFECTION. THERE WAS INFLAMMATION AROUND THE ANEURYSM SAC. THE PHYSICIAN BROUGHT THE PATIENT TO THE OPERATING ROOM TO EXPLANT THE GRAFT. AFTER THE STENT GRAFT WAS EXPLANTED; THE PHYSICIAN DID NOT BELIEVE THE STENT GRAFT WAS INFECTED. THE PHYSICIAN THINKS THERE MAY HAVE BEEN A TYPE IB THAT CAUSED THE ANEURYSM SAC TO GROW. THE STENT GRAFTS WERE SENT IN FOR A CULTURE. THE 16X13X82 WAS NOT EXPLANTED. THE 16X28X93 MAY HAVE HAD A TYPE IB ENDOLEAK, DUE TO DISEASE PROGRESSION. THE PHYSICIAN STATED THAT THE CULTURE GREW STREPTOCOCCUS; HOWEVER, THE STENT GRAFT WAS DISCARDED DUE TO MISHANDLING BY THE NURSE, IT GOT CONTAMINATED. THE PHYSICIAN BELIEVES THERE WAS JUST AN ENDOLEAK. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS DOING FINE IN RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692441 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01012912

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Required Intervention