BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX XPEDIENT ILIAC SG

    MDR report key: 6964291 · Received October 20, 2017

    Report

    Report Number
    2953200-2017-01605
    Event Type
    Injury
    Date Received
    October 20, 2017
    Date of Event
    September 12, 2017
    Report Date
    November 15, 2017
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: CATALOG # YRIRX16115, SERIAL # (B)(4), USE BY DATE: UNKNOWN, MANUFACTURED DATE: UNKNOWN, AND UPN# (B)(4). CATALOG # YRECX1655, SERIAL # (B)(4), USE BY DATE: UNKNOWN, MANUFACTURED DATE: UNKNOWN, AND UPN# (B)(4).

    Additional Manufacturer Narrative · 1

    THE MAIN COMPONENT OF THE SYSTEM. ADDITIONAL INFORMATION FOR PREVIOUSLY REPORTED OTHER RELEVANT DEVICES ARE: USE BY DATE: 2006-02-05, MANUFACTURED DATE: 2004-02-12. USE BY DATE: 2006-02-03, MANUFACTURED DATE: 2004-02-10. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CORRECTION: ERROR IN TIME LINE FROM INDEX PROCEDURE TO EVENT DATE NOTED *THREE YEARS* SHOULD BE 13 YEARS. ADDITIONAL INFORMATION RECEIVED ON THIS CASE CONFIRMED THAT A CT SCAN PERFORMED APPROXIMATELY 13 YEARS POST INDEX PROCEDURE, CONFIRMED THAT THE RIGHT COMMON ILIAC WAS DILATED TO 42 MM BELOW THE GRAFT. THE 16-LIMB MAINTAINED SEAL IN THE MID COMMON BUT DILATED DISTAL TO THE GRAFT. IT WAS ALSO CONFIRMED THAT DURING INDEX PROCEDURE TWO 16X16X115 AND ONE 16X16X55 LIMBS WERE IMPLANTED IN THE RIGHT COMMON ILIAC ARTERY. THE 16X16X55 WAS THE MOST DISTAL LIMB. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT, APPROXIMATELY THREE YEARS AND TEN MONTHS POST INDEX PROCEDURE, A CT REVEALED THAT THE ANEURX BIFURCATE HAD MIGRATED AND WAS NOW 15 MM DISTAL TO THE LOWEST RENAL ARTERY. THE PROXIMAL AORTIC NECK WAS OBSERVED TO HAVE DILATED TO 42 MM IN DIAMETER. THE ABDOMINAL AORTIC ANEURYSM APPEARED TO BE SEALED AND MEASURED 29 MM X 33 MM IN DIAMETER. THE RIGHT COMMON ILIAC ARTERY ALSO HAD DILATED TO 42 MM IN DIAMETER. A CUT DOWN WAS PERFORMED ON THE RIGHT GROIN AND A 12MM PLUG WAS PLACED IN THE RIGHT INTERNAL ILIAC ARTERY. AN ENDURANT LIMB WAS THEN IMPLANTED IN THE PREVIOUSLY PLACED ANEURX LIMB TO EXTEND INTO THE RIGHT EXTERNAL ILIAC ARTERY. THIS RESOLVED THE EVENT. PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS RELATED TO DISEASE PROGRESSION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744370 ANEURX XPEDIENT ILIAC SG SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND YRIRX16115

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention