BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC ANEURX BIFURCATED STENT GRAFT

    MDR report key: 292012 · Received August 24, 2000

    Report

    Report Number
    2953738-2000-00039
    Event Type
    Injury
    Date Received
    August 24, 2000
    Date of Event
    February 1, 2000
    Report Date
    July 25, 2000
    Manufacturer
    MEDTRONIC AVE PERIPHERAL DIVISION
    Product Code
    MAF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN 1997, A PT WITHOUT A SIGNIFICANT MEDICAL HISTORY 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 REVEALED AN INFRARENAL AORTIC ANEURYSM MEASURING 5.4CM IN DIAMETER, 16MM LONG, WITH A LEFT ANTERIOR ANGULATED NECK. PRESENCE OF THROMBUS WAS ALSO NOTED POSTERIORLY. DURING DEPLOYMENT OF THE STENT GRAFT SYSTEM, AN INTRA-PROCEDURAL MIGRATION OF THE STENT GRAFT OCCURRED, WHICH WAS SUCCESSFULLY RESOLVED WITH THE PLACEMENT OF AN AORTIC EXTENSION STENT GRAFT CUFF. POSTOPERATIVE ANGIOGRAMS EXCLUDED THE PRESENCE OF ENDOLEAKS. THE FIRST POSTOPERATIVE DAY, THE PT UNDERWENT THROMBOEMBOLECTOMY OF THE RIGHT FEMORAL ARTERY FOR ACUTE ISCHEMIA. SPIRAL CT SCANS PERFORMED AT ROUTINE 1 MONTH AND 6 MONTH FOLLOW UP WERE NEGATIVE FOR ENDOLEAK AND/OR MIGRATION OF THE STENT GRAFT. HOWEVER, DURING THE FOLLOW UP PHASE, THE PT WAS TREATED FOR DEEP VEIN THROMBOSIS OF THE RIGHT LOWER EXTREMITY WITH WARFARIN. SUBSEQUENTLY, THE PT PRESENTED TO THE EMERGENCY DEPT ON 04/28/2000 WITH LOWER BACK PAIN AND NO OTHER CLINICAL SIGNS OR SYMPTOMS. EMERGENT CT SCAN REVEALED A FISSURE OF THE AORTIC ANEURYSM WITH POSTERIOR PLACEMENT OF THE STENT GRAFT. 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 INITIALLY WAS PLACED 20MM BELOW THE OPTIMAL ATTACHMENT ZONE WITHIN THE PROXIMAL NECK. IN THIS LOCATION, THE PROXIMAL SEAL WAS A VERY TENTATIVE HIGH RISK. SUBSEQUENT ANEURYSM EXPANSION AND RUPTURE IS LIKELY TO HAVE BEEN CAUSED BY LOSS OF THE MARGINAL PROXIMAL NECK SEAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Life Threatening| R