BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT II EXTENSION CUFF

    MDR report key: 4060201 · Received September 4, 2014

    Report

    Report Number
    2953200-2014-01765
    Event Type
    Injury
    Date Received
    September 4, 2014
    Date of Event
    August 7, 2014
    Report Date
    October 23, 2014
    Manufacturer
    MEDTRONIC IREALAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A MYCOTIC SACCULAR THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT THERE WAS AN ENDOLEAK NOTED POST PROCEDURE. THE PHYSICIAN ADDED AN ABDOMINAL CUFF PROXIMALLY. THE PHYSICIAN WAS SATISFIED WITH THE RESULTS. THREE MONTHS POST CT WAS DONE AND NO ENDOLEAK WAS DETECTED. THE PATIENT RETURNED FOR A CT FOLLOW-UP AND WAS COMPLAINING OF DIFFICULTY TO SWALLOW. THERE WAS AN ENDOLEAK ABOUT 55MM FROM THE TOP OF THE STENT GRAFT. THE PHYSICIAN SUSPECTED IT AS EITHER A TYPE III OR TYPE IB ENDOLEAK. THE ANEURYSM SAC GREW FROM SACCULAR ONE YEAR AGO TO FUSIFORM IN SHAPE. A RE-INTERVENTION WAS PERFORMED TO DETERMINE THE TYPE OF ENDOLEAK AND TO TREAT THE PATIENT ACCORDINGLY. A VALIANT STENT GRAFT WAS IMPLANTED DISTALLY INFRA-CELIAC (20MM FROM THE PREVIOUS VALIANT STENT GRAFT). THE ENDOLEAK WAS STILL NOTED. AN ADDITIONAL STENT GRAFT WAS IMPLANTED PROXIMALLY (10MM FROM THE PREVIOUS ENDURANT CUFF). THE ENDOLEAK WAS RESOLVED AFTER THE SECOND STENT GRAFT WAS IMPLANTED. THE PHYSICIANS DETERMINED THAT THE ENDOLEAK PREVIOUSLY NOTED WAS A TYPE III SEPARATION AND TYPE IB ENDOLEAK. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE. A REVIEW OF RETURNED FILMS REVEALED THAT THERE IS A SACCULAR ANEURYSM IN THE DESCENDING THORACIC AORTA; APPROXIMATELY 9CM PROXIMAL TO THE CELIAC ARTERY. THE THORACIC AORTA DIAMETER IS APPROXIMATELY 22MM ABOVE THE ANEURYSM, AND MEASURES 25MM JUST BELOW THE ANEURYSM. THE ANEURYSM EXTENDS OUT 1CM X 2CM LONG. THE NEXT IMAGE SHOWS THE PROXIMAL 6 STENTS ARE VISIBLE FROM A VALIANT STENT GRAFT THAT HAS BEEN IMPLANTED. AN ENDURANT AORTIC CUFF HAS ALSO BEEN IMPLANTED APPROXIMATELY 2CM ABOVE THE VALIANT; THERE IS APPROXIMATELY 2CM OF FABRIC OVERLAP BE\TWEEN THE TWO DEVICES. NO CONTRAST INJECTIONS WERE PERFORMED IN THE RETURNED IMAGE, THEREFORE, ANY POSSIBLE ENDOLEAK COULD NOT BE ASSESSED. NO SCALE IS AVAILABLE FOR ANY MEASUREMENTS. ANGIO IMAGES FROM 1 YEAR POST-IMPLANT SHOWS THAT A PROXIMAL VALIANT STENT GRAFT HAS BEEN IMPLANTED; EXTENDING APPROXIMATELY 15MM ABOVE THE PROXIMAL ENDURANT AORTIC CUFF. A VALIANT DISTAL STENT GRAFT WAS ALSO SEEN IMPLANTED; EXTENDING APPROXIMATELY 2CM BELOW THE ORIGINALLY IMPLANTED VALIANT, AND APPROXIMATELY 15MM PROXIMAL TO THE CELIAC. FINAL ANGIO SHOWS NO VISIBLE CONTRAST. CONTRAST IMAGES PRIOR TO THE SECONDARY INTERVENTION WERE NOT PROVIDED. THE REPORTED ENDOLEAK(S) WAS NOT SEEN IN THE FILMS AND THEREFORE CANNOT BE ASSESSED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FOR THIS CASE THE REVIEW OF (INCOMPLETE) RETURNED FILMS REVEALED THAT THERE IS A SACCULAR ANEURYSM IN THE DESCENDING THORACIC AORTA; APPROXIMATELY 9CM PROXIMAL TO THE CELIAC ARTERY. THE THORACIC AORTA DIAMETER IS APPROXIMATELY 22MM ABOVE THE ANEURYSM, AND MEASURES 25MM JUST BELOW THE ANEURYSM. THE ANEURYSM EXTENDS OUT 1CM X 2CM LONG. THE NEXT IMAGE SHOWS THE PROXIMAL 6 STENTS ARE VISIBLE FROM A VALIANT STENT GRAFT THAT HAS BEEN IMPLANTED. AN ENDURANT AORTIC CUFF HAS ALSO BEEN IMPLANTED APPROXIMATELY 2CM ABOVE THE VALIANT; THERE IS APPROXIMATELY 2CM OF FABRIC OVERLAP BETWEEN THE TWO DEVICES. NO CONTRAST INJECTIONS WERE PERFORMED IN THE RETURNED IMAGE, THEREFORE ANY POSSIBLE ENDOLEAK COULD NOT BE ASSESSED. NO SCALE IS AVAILABLE FOR ANY MEASUREMENTS. CTA'S ARE INCOMPLETE (STENT GRAFTS ARE NOT VISIBLE) AND THE FILMS CANNOT BE ASSESSED. ANGIO IMAGES FROM 1 YEAR POST-IMPLANT SHOWS THAT A PROXIMAL VALIANT STENT GRAFT HAS BEEN IMPLANTED; EXTENDING APPROXIMATELY 15MM ABOVE THE PROXIMAL ENDURANT AORTIC CUFF. A VALIANT DISTAL STENT GRAFT WAS ALSO SEEN IMPLANTED; EXTENDING APPROXIMATELY 2CM BELOW THE ORIGINALLY IMPLANTED VALIANT, AND APPROXIMATELY 15MM PROXIMAL TO THE CELIAC. FINAL ANGIO SHOWS NO VISIBLE CONTRAST. CONTRAST IMAGES PRIOR TO THE SECONDARY INTERVENTION WERE NOT PROVIDED. THE REPORTED ENDOLEAK(S) WAS NOT SEEN IN THE FILMS AND THEREFORE CANNOT BE ASSESSED. THE CAUSE OF EVENTS COULD NOT BE DETERMINED FROM THE FILMS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541172 ENDURANT II EXTENSION CUFF SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IREALAND V03011466

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Required Intervention