BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2883946 · Received December 21, 2012

    Report

    Report Number
    2953200-2012-02459
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    November 8, 2010
    Report Date
    November 22, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: INHERENT RISK OF PROCEDURE (ENDOLEAK, FEVER); PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (RENAL COMPLICATIONS); LACK OF INFORMATION (UNKNOWN CAUSE OF ENDOLEAK). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (RENAL COMPLICATIONS).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 5.5 CM DIAMETER FUSIFORM ABDOMINAL AORTIC ANEURYSM APPROXIMATELY 25 MONTHS AGO. THE INFRARENAL NECK ANGLE WAS 37 DEGREES. AORTIC NECK WAS 22 MM IN DIAMETER AND 15 MM LONG. DISTAL AORTA WAS 25 MM IN DIAMETER. THE RIGHT ILIAC ARTERY WAS 9 MM IN DIAMETER. THE ILIAC ARTERIES WERE MODERATELY TORTUOUS BILATERALLY. THE LEFT FEMORAL ARTERY WAS 9 MM IN DIAMETER. THERE WAS A LEFT ILIAC ANEURYSM 15MM IN DIAMETER X 3.5MM LONG. THERE WAS NO ILIAC STENOSIS. THERE WAS 10% MURAL THROMBUS/CALCIFICATION IN THE PROXIMAL NECK. FOUR DAYS POST IMPLANT A FEVER WAS REPORTED. THE PATIENT RECEIVED CORTICOID THERAPY AND THE EVENT RESOLVED ON THE SAME DAY. ONE DAY LATER THE PATIENT ALSO HAD RENAL FUNCTION COMPLICATION WITH INCREASED CREATININE LEVELS OF 2.63 MG/ML. HYDRATION AND CORTICOID THERAPY RESOLVED THE EVENT ON THE SAME DAY. THE CREATININE VALUE DECREASED AND THE PATIENT WAS STABILIZED. PER THE INVESTIGATOR THIS WAS EXPECTED AS PATIENT HAS CHRONIC RENAL FAILURE. INVESTIGATOR ASSESSED RENAL AND FEVER EVENTS RELATED TO PROCEDURE AND NOT RELATED TO THE DEVICE. THE PATIENT WAS DISCHARGED ON EIGHT DAYS POST IMPLANT. THE PATIENT WAS CONTACTED 15 MONTHS POST IMPLANT TO SCHEDULE A FOLLOW UP VISIT AND THE PATIENT´S WIFE STATED THE PATIENT HAS BEEN HOSPITALIZED SINCE FOUR MONTHS AGO FOR 3 WEEKS DUE TO WORSENING OF THE CHRONIC RENAL FAILURE. SINCE THE HOSPITALIZATION THE PATIENT WAS PLACED ON DIALYSIS. THE INVESTIGATOR ASSESSED THIS EVENT AS NOT RELATED TO THE DEVICE OR THE PROCEDURE. TWO YEARS POST IMPLANT THERE WAS A PROXIMAL TYPE I ENDOLEAK SEEN ON CT SCAN. THE INVESTIGATOR ASSESSED THIS EVENT AS RELATED TO THE DEVICE AND NOT TO THE PROCEDURE. SECONDARY INTERVENTION WAS PERFORMED WITH PLACEMENT OF AN ENDURANT 32X32X49 AORTIC CUFF STENT GRAFT APPROXIMATELY ONE MONTH AGO AND THE ENDOLEAK RESOLVED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANT ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V00495026

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention