BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II

    MDR report key: 3881885 · Received June 18, 2014

    Report

    Report Number
    2953200-2014-01217
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    April 1, 2014
    Report Date
    July 16, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    EXACT DATE OF EVENT IS UNKNOWN. (B)(4). RESULTS: DEVICE EVALUATION PENDING.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. THE PATIENT'S FEVER WENT DOWN AFTER THE OPEN REPAIR.

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 90MM DIAMETER ABDOMINAL AORTIC ANEURYSM. THE PROXIMAL NECK WAS 19 MM IN DIAMETER. THE LEFT COMMON ILIAC ARTERY WAS 25 MM IN DIAMETER AND THE RIGHT COMMON ILIAC ARTERY WAS 25 MM IN DIAMETER. THE RIGHT INTERNAL ILIAC ARTERY MEASURED 24 MM IN DIAMETER AND THE LEFT INTERNAL ILIAC ARTERY MEASURED 25 MM IN DIAMETER. THE RIGHT EXTERNAL ILIAC ARTERY MEASURED 9 MM IN DIAMETER, AND THE LEFT EXTERNAL ILIAC ARTERY IS 10 MM IN DIAMETER. IT WAS REPORTED THAT APPROXIMATELY SIX MONTHS POST INDEX PROCEDURE THE PATIENT COMPLAINED OF A HIGH FEVER. THE PATIENT WAS TREATED WITH MEDICATION FOR 10 DAYS. THE ANEURYSM HAS ENLARGED TO 10 CM IN DIAMETER. THE DEVICES WERE EXPLANTED AND A SYNTHETIC VESSEL WAS IMPLANTED. THE PHYSICIAN SUSPECTED AN INFECTION AS THE ENLARGED ANEURYSM WAS CONFIRMED, WHICH WAS POSSIBLE THAT THE ANEURYSM WAS ENLARGED DUE TO INFECTION. THE TEST RESULTS SHOWED THAT THE PATIENT HAD NO INFECTION. AS THE PATIENT HAD A HIGH FEVER, GRAFT INFECTION WAS SUSPECTED AND TREATMENT WITH MEDICATION WAS CONTINUED. BUT IT WAS INEFFECTIVE AGAINST THE HIGH FEVER, WHICH HAD LED TO REMOVAL OF THE DEVICE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED. THE PHYSICIAN STATED THAT THE INFECTION POSSIBLY CAUSED THE ANEURYSM ENLARGEMENT.

    Description of Event or Problem · 1

    EVALUATION SUMMARY: THE DEVICE WAS EXPLANTED DURING SURGICAL CONVERSION DUE TO ANEURYSM ENLARGEMENT. THE PATIENT WAS INITIALLY TREATED FOR A 9 CM INFRARENAL ABDOMINAL AORTIC ANEURYSM. DETAILS AT IMPLANT AND INITIAL POST-IMPLANT FOLLOW-UP¿S WERE NOT PROVIDED. APPROXIMATELY 6 MONTHS POST-IMPLANT THE PATIENT COMPLAINED OF A HIGH FEVER, AND THE AAA DIAMETER WAS FOUND TO HAVE ENLARGED TO 10 CM. THE PATIENT WAS TREATED WITH MEDICATION FOR 10 DAYS. THE PHYSICIAN SUSPECTED THAT THE ANEURYSM MAY HAVE ENLARGED DUE TO AN INFECTION; HOWEVER, TEST RESULTS COULD NOT CONFIRM ANY INFECTION. TREATMENT WITH MEDICATION WAS CONTINUED IN AN ATTEMPT TO REDUCE THE HIGH FEVER, BUT THIS WAS INEFFECTIVE AGAINST THE HIGH FEVER AND THE DECISION WAS MADE TO REMOVE THE STENT GRAFTS DURING OPEN REPAIR. DURING THE EXPLANT NO STENT GRAFT ISSUES WERE REPORTED; THE PATIENT WAS SUCCESSFULLY CONVERTED AND THE FEVER WENT DOWN SOON AFTER THE OPEN REPAIR. THE PHYSICIAN COMMENTED THAT EITHER A TYPE II ENDOLEAK OR A POSSIBLE INFECTED ANEURYSM MAY HAVE BEEN THE CAUSE OF THE ANEURYSM ENLARGEMENT. FROM THE EXAMINATION OF THE RETURNED DEVICES AND CLINICAL INFORMATION PROVIDED, THE CAUSE OF THE ANEURYSM ENLARGEMENT COULD NOT BE DETERMINED. THE BIFURCATE WAS RETURNED TRANSECTED JUST PROXIMAL TO THE FLOW DIVIDER; THE 4CM LENGTH PROXIMAL SECTION OF THE AORTIC BODY (SPRINGS 1 ¿ 4; INCLUDING THE SUPRARENAL STENTS) WAS NOT RETURNED, THEREBY LIMITING THE EXTENT OF THE EVALUATION. THE IPSILATERAL EXTENSION WAS ALSO TRANSECTED AT THE DISTAL END; THE 1 CM LENGTH SECTION OF SPRING 9 WAS NOT RETURNED. OTHER THAN THESE TRANSECTION CUTS, NO STENT GRAFT INTEGRITY ISSUES WERE OBSERVED WITH ANY OF THE STENT GRAFT COMPONENTS. THE DEVICES WERE ALSO CONFIRMED TO HAVE MET ALL ENDURANT II MANUFACTURING SPECIFICATIONS PRIOR TO SHIPMENT. IT IS POSSIBLE THAT THE REPORTED TYPE II ENDOLEAK OR AN INFECTED ANEURYSM MAY HAVE CONTRIBUTED TO THE AAA ENLARGEMENT. IT IS UNLIKELY THAT THE STENT GRAFT MAY HAVE BEEN THE SOURCE OF THE POSSIBLE INFECTED ANEURYSM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357213 ENDURANT II SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V04108124

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention