BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT STENT GRAFT SYSTEM

    MDR report key: 2761140 · Received September 26, 2012

    Report

    Report Number
    2953200-2012-01857
    Event Type
    Injury
    Date Received
    September 26, 2012
    Date of Event
    November 12, 2010
    Report Date
    August 30, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION CODE, RESULTS: INHERENT RISK OF PROCEDURE (ENDOLEAK); PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (SEVERELY TORTUOUS ILIAC ARTERIES) EVALUATION CODES, CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (SEVERELY TORTUOUS ILIAC ARTERIES).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 7.4 CM FUSIFORM IN DIAMETER ABDOMINAL AORTIC ANEURYSM APPROXIMATELY 24 MONTHS AGO. VESSEL MORPHOLOGY FROM THE TIME OF IMPLANT WAS REPORTED AS THE AORTIC NECK WAS SEVERELY ANGULATED, 90 DEGREES. AORTIC NECK WAS 24MM IN DIAMETER AND 25 MM LONG. DISTAL AORTA WAS 44MM IN DIAMETER. RIGHT ILIAC WAS 8 MM IN DIAMETER. ILIACS WERE MODERATELY TORTUOUS WITH 5% STENOSIS. IT WAS REPORTED THAT AFTER THE ENDURANT GRAFT WAS DEPLOYED, UNINTENTIONAL STENT GRAFT TWISTING WAS REPORTED. THE PHYSICIAN COMMENTED ON THERE WAS AN INTENSE TWISTED LEG POSITION. THERE WAS NO EVIDENCE OF STENT GRAFT KINKING. IT WAS REPORTED THAT ONE MONTH POST INDEX PROCEDURE THE CT REVEALED A PROXIMAL TYPE IA AND A DISTAL TYPE IB ENDOLEAK. THE ENDOLEAKS WERE SUCCESSFULLY TREATED WITH A RELIANT BALLOON IN A SECONDARY INTERVENTION. THE INVESTIGATOR ASSESSMENT STATES THAT THE EVENTS ARE NOT RELATED TO THE STUDY DEVICE OR THE STUDY PROCEDURE. IT WAS REPORTED THAT AT THE ONE YEAR FOLLOW-UP, PATIENT HAD CT IMAGING. A TECHNICAL OBSERVATION WAS NOTED, THERE WAS EVIDENCE OF A TYPE IB ENDOLEAK COMING FROM THE RIGHT LIMB IN THE COMMON ILIAC ARTERY. THE ILIAC ARTERY WAS SEVERELY TORTUOUS MAKING IT IMPOSSIBLE FOR THE PHYSICIAN TO EXTEND THE GRAFT DISTALLY. BALLOON REMODELING WAS PERFORMED HOWEVER UNSUCCESSFULLY. THE ENDOLEAK DID NOT RESOLVE. THE PHYSICIAN WILL MONITOR THE PATIENT. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    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 V00364426

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR Required Intervention