BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC ANEURX BIFURCATED STENT GRAFT

    MDR report key: 292019 · Received August 24, 2000

    Report

    Report Number
    2953738-2000-00038
    Event Type
    Injury
    Date Received
    August 24, 2000
    Date of Event
    September 1, 1999
    Report Date
    July 25, 2000
    Manufacturer
    MEDTRONIC AVE PERIPHERAL DIVISION
    Product Code
    MIH
    Removal / Correction Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN 1997, A PT WITH A HISTORY OF LAPAROTOMY, COLECTOMY AND TEMPORARY COLOSTOMY WAS SELECTED FOR IMPLANT OF A 24MM DIAMETER X 14CM LENGTH MEDTRONIC AVE ANEURX BIFURCATED STENT GRAFT FOR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. PREOPERATIVE EVAL BY ANGIOGRAPHY, INTRAVASCULAR ULTRASOUND AND SPIRAL CT REVEALTED AN INFRARENAL AORTIC ANEURYSM MEASURING 6.5CM IN DIAMETER, 15 MM LONG, WITH AN ANTERIORLY ANGULATED NECK. PRESENCE OF THROMBUS WAS ALSO NOTED POSTERIORLY. PERIOPERATIVE ANGIOGRAMS PERFORMED FOLLOWING IMPLANT OF BIFURCATED STENT GRAFT DEMONSTRATED A BILATERAL DISTAL ENDOLEAK, WHICH WERE RESOLVED WITH THE ADDITION OF ILIAC EXTENDER STENT GRAFT CUFFS. POSTOPERATIVE ANGIOGRAMS EXCLUDED THE PRESENCE OF ENDOLEAKS. SPIRAL CT SCANS PERFORMED AT ROUTINE 1 MONTH AND 6 MONTH FOLLOW UP WERE NEGATIVE FOR ENDOLEAK AND/OR MIGRATION OF STENT GRAFT. HOWEVER, THE 20 MONTH CT SCAN DEMONSTRATED A MIGRATION OF THE PROXIMAL PORTION OF THE STENT GRAFT AND AN INCREASE IN ANEURYSM DIAMETER. SUBSEQUENTLY, THE PT PRESENTED TO THE EMERGENCY DEPT IN 1999 WITH ABDOMINAL PAIN AND HYPOTENSION. EMERGENT CT SCAN REVEALED A RUPTURE OF THE AORTIC ANEURYSM WITH RETROPERITONEAL HEMATOMA AND MIGRATION OF THE STENT GRAFT INTO THE ANEURYSM. THE PT UNDERWENT EMERGENT SURGERY WITH REMOVAL OF THE STENT GRAFT AND PLACEMENT OF AN AORTO-ILIAC BIFURCATED CONVENTIONAL GRAFT. THE PT'S POSTOPERATIVE COURSE WAS UNEVENTFUL. THERE WERE NO ADD'L CLINICAL SEQUELAE REPORTED RELATIVE TO THE EVENT. THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. QUANTITATIVE AND VISUAL ANALYSIS OF CONTRAST-ENHANCED CT SCANS WERE PERFORMED BY MEDICAL MEDIA SYSTEMS ON 08/14/2000. THE ANALYSIS CONCLUDED THAT THE STENT GRAFT APPEARS TO HAVE BEEN POSITIONED TOO LOW AT THE BOTTOM OF THE PROXIMAL NECK RESULTING IN MARGINAL PROXIMAL SEAL. THE LOSS OF PROXIMAL NECK SEAL APPEARS TO HAVE ALLOWED SUBSEQUENT ANEURYSM EXPANSION AND DISTAL MIGRATION OF THE STENT GRAFT WITH EVENTUAL RUPTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC ANEURX BIFURCATED STENT GRAFT AAA STENT GRAFT MIH MEDTRONIC AVE PERIPHERAL DIVISION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Life Threatening| R