BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2963952 · Received February 15, 2013

    Report

    Report Number
    2953200-2013-00261
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    January 23, 2013
    Report Date
    March 7, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P100020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: ENDOLEAK. CONICALLY SHAPED AORTIC NECK. CONCLUSION: CONICALLY SHAPED AORTIC NECK.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED AS FOLLOWS: THE AORTIC NECK LENGTH AND ANGULATION WERE UNREMARKABLE. THE CAUSE OF THE ENDOLEAK WAS LIKELY RELATED TO THE SEVERELY CONICAL AORTIC NECK (TAPERED NECK). ON AN UNKNOWN DATE THE PATIENT UNDERWENT A SECONDARY INTERVENTION WITH ANOTHER MANUFACTURER'S AORTIC CUFF STENT GRAFT AND RESOLVED THE PROXIMAL TYPE I ENDOLEAK. NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 54 MM DIAMETER ABDOMINAL AORTIC ANEURYSM APPROXIMATELY THREE WEEKS AGO. THE AORTIC NECK WAS 19-30 MM IN DIAMETER FROM PROXIMAL TO DISTAL. THE LEFT COMMON ILIAC ARTERY WAS 11 MM IN DIAMETER AND THE RIGHT COMMON ILIAC ARTERY WAS 15 MM IN DIAMETER. THE STENT GRAFT GRAFTS WERE IMPLANTED WITHOUT COMPLICATION. IT WAS REPORTED THAT ON THE FINAL ANGIOGRAM A PROXIMAL TYPE I ENDOLEAK WAS NOTED. THE PHYSICIAN PERFORMED A TOUCH-UP WITH A BALLOON; HOWEVER, THE ENDOLEAK DID NOT COMPLETELY RESOLVE. THE PHYSICIAN PERFORMED ANOTHER TOUCH-UP BUT THE ENDOLEAK DID NOT RESOLVE. THE DECISION WAS MADE TO INTERVENE AT A LATER DATE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67556 ENDURANT ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V01096440

    Patients

    Seq Age Sex Outcome Treatment
    1 00084 YR Required Intervention