BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANT STENT GRAFT SYSTEM

    MDR report key: 2801960 · Received October 23, 2012

    Report

    Report Number
    2953200-2012-02023
    Event Type
    Death
    Date Received
    October 23, 2012
    Date of Event
    February 2, 2014
    Report Date
    July 17, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION, RESULTS: INHERENT RISK OF PROCEDURE (ENDOLEAK); (CAUSE OF THE UNKNOWN TYPE III ENDOLEAK WHICH SELF-RESOLVED IS UNCERTAIN). EVALUATION, CONCLUSION: (CAUSE OF THE UNKNOWN TYPE III ENDOLEAK WHICH SELF-RESOLVED IS UNCERTAIN).

    Description of Event or Problem · 1

    AN ENDURANT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 65.1 MM IN DIAMETER FUSIFORM ABDOMINAL AORTIC ANEURYSM WAS REPORTED WITH AN INFRA-RENAL ANGLE OF 11.2 DEGREES. PROXIMAL AORTA WAS 23.6 MM IN DIAMETER AND 60.8 MM IN LENGTH. DISTAL AORTA WAS 31.4 MM IN DIAMETER. RIGHT ILIAC ARTERY WAS 15.9 MM IN DIAMETER AND THE LEFT ILIAC ARTERY WAS 13.6 MM IN DIAMETER. THE RIGHT FEMORAL ARTERY WAS 10.7 MM IN DIAMETER AND THE LEFT FEMORAL ARTERY WAS 9.6 MM IN DIAMETER. THE RIGHT AND LEFT ILIAC ARTERIES WERE MILDLY TORTUOUS WITH 0% STENOSIS. THE CIRCUMFERENTIAL AORTIC MURAL THROMBUS/CALCIFICATION AT THE PROXIMAL NECK WAS 10%. IT WAS REPORTED APPROXIMATELY ONE YEAR POST INDEX PROCEDURE THE PATIENT HAD AN ULTRASOUND WHICH INDICATED THAT THE ANEURYSM WAS 56 MM IN DIAMETER AND THERE WAS AN UNKNOWN TYPE III ENDOLEAK. THERE WAS A PATENT STENT WITH A MINOR TYPE III ENDOLEAK OBSERVED; WHICH WAS LEFT UNCORRECTED. THE INVESTIGATOR ASSESSMENT STATED THAT THE EVENT WAS RELATED TO THE STUDY DEVICE; HOWEVER IT WAS NOT RELATED TO THE STUDY PROCEDURE. IT WAS REPORTED 29 MONTHS POST INDEX PROCEDURE THE PATIENT HAD AN ULTRASOUND WHICH INDICATED THAT THE ANEURYSM WAS 56 MM IN DIAMETER AND THERE WAS A TECHNICAL OBSERVATION OF AN UNKNOWN TYPE III ENDOLEAK. THERE WAS A PATENT STENT WITH A KNOWN TYPE III ENDOLEAK OBSERVED; WHICH WAS LEFT UNCORRECTED. A CT WAS 14 DAYS LATER AND THERE WAS NO EVIDENCE OF ANY ENDOLEAK. THE ENDOLEAK HAS RESOLVED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PATIENT EXPIRED. THE DEATH REPORT IS NOT AVAILABLE. NO OTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. THE INVESTIGATOR ASSESSED THE DEATH AS NOT 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 ENLW1620C120EE

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Death