BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT STENT GRAFT SYSTEM

    MDR report key: 2781559 · Received October 10, 2012

    Report

    Report Number
    2953200-2012-01939
    Event Type
    Death
    Date Received
    October 10, 2012
    Date of Event
    August 11, 2011
    Report Date
    September 14, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: INHERENT RISK OF PROCEDURE (INFECTION).

    Description of Event or Problem · 1

    AN ENDURANT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A FUSIFORM, 52 MM IN DIAMETER ABDOMINAL AORTIC ANEURYSM. THE ILIAC ARTERIES ARE MILDLY TORTUOUS. IT WAS REPORTED THAT THE PATIENT HAD RENAL FAILURE, PNEUMONIA, AND RESPIRATORY DEPRESSION/FAILURE TWO DAYS POST INDEX PROCEDURE. THE PATIENT REQUIRED PROLONGATION OF EXISTING HOSPITALIZATION AND MEDICATION/OXYGEN. THE PATIENT RECOVERED FIVE DAYS POST INDEX PROCEDURE FROM THE RENAL FAILURE. THE PNEUMONIA AND RESPIRATORY DEPRESSION/FAILURE EVENTS ARE CONTINUING. THE INVESTIGATOR ASSESSMENT STATES THAT THE EVENTS ARE NOT RELATED TO THE STUDY DEVICE, HOWEVER, THEY ARE RELATED TO THE STUDY PROCEDURE. THE PATIENT PRESENTED WITH CELLULITIS AND RECOVERED WITH THE USE OF SILVADENE CREAM AND COMPRESSION WRAPS. THE INVESTIGATOR DETERMINED ALL OF THE AFOREMENTIONED EVENTS TO BE PROCEDURE RELATED, THOUGH NOT DEVICE RELATED. IT WAS REPORTED APPROXIMATELY ONE MONTH INDEX PROCEDURE, THE PATIENT PRESENTED WITH A FEVER. THE INVESTIGATOR ASSESSED THAT THIS EVENT WAS NOT DEVICE OR PROCEDURE RELATED. THE PATIENT RECOVERED FROM THESE CLINICAL EVENTS. IT WAS REPORTED THAT APPROXIMATELY THIRTEEN MONTHS POST INDEX PROCEDURE, THE PATIENT SUFFERED CARDIOGENIC AND SEPTIC SHOCK AND EXPIRED. THE INVESTIGATOR ASSESSED THAT THE DEATH WAS NOT DEVICE OR PROCEDURE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V00904376

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Death