BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT

    MDR report key: 3170792 · Received June 14, 2013

    Report

    Report Number
    2953200-2013-01132
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    May 27, 2010
    Report Date
    May 22, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: INHERENT RISK OF PROCEDURE (ENDOLEAKS); (INSUFFICIENT INFORMATION; CAUSE OF THE EVENTS IS UNKNOWN); FAILURE TO FOLLOW INSTRUCTIONS (PER INVESTIGATOR¿S DOCUMENTED REPORT). CONCLUSIONS: KNOWN INHERENT RISK OF A PROCEDURE (ENDOLEAKS); (INSUFFICIENT INFORMATION; CAUSE OF THE EVENTS IS UNKNOWN); FAILURE TO FOLLOW INSTRUCTIONS (PER INVESTIGATOR¿S DOCUMENTED REPORT).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE TREATMENT OF A 66.8MM IN DIAMETER FUSIFORM ABDOMINAL AORTIC ANEURYSM. THE PROXIMAL AORTIC NECK WAS 27-28MM IN DIAMETER AND 37.2MM LONG. THE DISTAL AORTA WAS 29MM IN DIAMETER. THE PROXIMAL TO DISTAL DIAMETERS OF THE RIGHT ILIAC ARTERY WERE 14-15.6-13.5MM. THE DIAMETER OF THE LEFT ILIAC ARTERY WAS 11MM. THE DIAMETER OF THE RIGHT FEMORAL ARTERY WAS 7.9MM, AND THE LEFT FEMORAL ARTERY WAS 7.7MM. THERE WAS LEFT ILIAC ANEURYSM WITH A DIAMETER OF 29.2MM AND A LENGTH OF 42.16MM. THE ILIAC ARTERIES WERE MILDLY TORTUOUS. THE PATIENT HAD AN AORTO-BI-ILIAC BYPASS GRAFT. IT WAS REPORTED THAT AFTER THE INDEX PROCEDURE A PROXIMAL TYPE 1 ENDOLEAK WAS SEEN. THE FOLLOWING DAY ANOTHER MANUFACTURER¿S PERIPHERAL ENDOPROSTHESIS WAS IMPLANTED AT THE HEIGHT OF THE LEFT DISTAL ANASTOMOSIS OF THE AORTO-BI-ILIAC BYPASS GRAFT TO TREAT THE ENDOLEAK, BUT THE LEAK DID NOT RESOLVE. APPROXIMATELY FIVE MONTHS LATER THE PROXIMAL TYPE 1 ENDOLEAK REQUIRED A SECONDARY INTERVENTION. THE PROXIMAL END OF THE STENT GRAFT WAS DILATED AND THE ENDOLEAK RESOLVED. A FOLLOW-UP CT DONE ONE YEAR POST INDEX PROCEDURE SHOWED A CONTINUED PROXIMAL TYPE I ENDOLEAK. THIS EVENT HAS NOT RESULTED IN ADDITIONAL SECONDARY INTERVENTIONS. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272012 ENDURANT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V00441886

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR Required Intervention