BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 3011689 · Received March 19, 2013

    Report

    Report Number
    2953200-2013-00491
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 21, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: INFECTION. PRE-OPERATIVELY INFECTED PSEUDOANEURYSM. TREATMENT OF A PATIENT WITH A PSEUDOANEURYSM. CONCLUSIONS: PRE-OPERATIVELY INFECTED PSEUDOANEURYSM. TREATMENT OF A PATIENT WITH A PSEUDOANEURYSM.

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A PSEUDOANEURYSM APPROXIMATELY TWO MONTHS AGO. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY AT THE HOSPITAL WITH COMPLAINTS OF ABDOMINAL PAIN. IT WAS DETERMINED THAT THE STENT GRAFTS WERE INFECTED. THE PATIENT WAS ADMITTED AND THE STENT GRAFTS WERE EXPLANTED. CULTURES WERE DONE AND CAME BACK POSITIVE FOR MRSA. THE PHYSICIAN BELIEVES THE INFECTION WAS LIKELY PRESENT IN THE PSEUDOANEURYSM PRIOR TO THE EVAR. THE EXPLANTED STENT GRAFTS WERE DISCARDED BY THE USER FACILITY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114911 ENDURANT II ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01690267

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Required Intervention