BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX STENT GRAFT SYSTEM

    MDR report key: 5660721 · Received May 17, 2016

    Report

    Report Number
    2953200-2016-01052
    Event Type
    Injury
    Date Received
    May 17, 2016
    Date of Event
    April 12, 2003
    Report Date
    April 28, 2016
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXACT DATES OF THE EVENTS ARE UNKNOWN. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: SEX. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED; EVALUATION OF THE PROXIMAL AORTIC NECK ENLARGEMENT FOLLOWING ENDOVASCULAR REPAIR OF ABDOMINAL AORTIC ANEURYSM: 3-YEARS EXPERIENCE VINICIO NAPOLI, SAVINO G. SARDELLA, IRENE BARGELLINI, PASQUALE PETRUZZI, ROBERTO CIONI, CLAUDIO VIGNALI, MAURO FERRARI, CARLO BARTOLOZZI (EUR RADIOL (2003) 13:1962-1971) ANEURX STENT GRAFT SYSTEMS WERE IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF ABDOMINAL ANEURYSM REPAIR. THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: TYPE IA ENDOLEAK, MIGRATION, TYPE IV ENDOLEAK. ABSTRACT THE AIM OF THIS STUDY WAS TO EVALUATE INCIDENCE, POTENTIAL RISK FACTORS AND EFFECTS ON STENT-GRAFT MIGRATION OF PROXIMAL NECK DILATATION AFTER ENDOLUMINAL REPAIR OF ABDOMINAL AORTIC ANEURYSM (EVAR), AND THE ROLE OF ULTRASOUND (US) IN DETECTING NECK ENLARGEMENT. FROM NOVEMBER 1998 TO OCTOBER 2001, 90 PATIENTS UNDERWENT EVAR. ON FOLLOW-UP, US AND CT ANGIOGRAPHY (CTA) WERE PERFORMED, AND DIAMETERS OF THE SUPRARENAL AND INFRARENAL AORTIC NECKS WERE MONITORED. INCIDENCE OF SIGNIFICANT NECK ENLARGEMENT (=2.5 MM) AND DISTAL STENT GRAFT MIGRATION (>10 MM) WAS CALCULATED. SEVERAL FACTORS WERE EVALUATED AS PREDICTIVE OF NECK ENLARGEMENT. ULTRASOUND AND CTA MEASUREMENTS WERE COMPARED. THE US AND CTA EXAMINATIONS WERE AVAILABLE IN 68, 39, AND 11 PATIENTS AT 1, 2, AND 3 YEARS FOLLOW-UP (MEAN FOLLOW-UP 15 MONTHS). INCIDENCE OF SIGNIFICANT NECK DILATATION WAS 21.8% AT THE INFRARENAL LEVEL (13, 33, AND 36% AT 1, 2, AND 3 YEARS FOLLOWUP)AND 13.8% AT THE SUPRARENAL LEVEL (9, 18, AND 27% AT 1, 2, AND 3 YEARS FOLLOW-UP). SIGNIFICANT STENT-GRAFT MIGRATION OCCURRED IN 14 OF 87 PATIENTS (16%) AND WAS ASSOCIATED WITH NECK DILATATION IN 8 (2 SUPRARENAL AND 6 INFRARENAL). NO RISK FACTORS WERE IDENTIFIED. ULTRASOUND WAS LESS ACCURATE THAN CT IN MEASURING NECK DIAMETER, IN PARTICULAR AT THE SUPRARENAL LEVEL. PROXIMAL AORTIC NECK ENLARGEMENT OCCURS IN UP TO 30% OF PATIENTS AFTER EVAR AND REPRESENTS THE MAIN RISK FACTOR FOR STENT-GRAFT MIGRATION. THE RISK OF INFRARENAL NECK DILATATION IS HIGHER AT 2 YEARS FOLLOW-UP, WHEREAS THE SUPRARENAL NECK ENLARGES LATER. ULTRASOUND IS NOT USEFUL IN MONITORING NECK DIAMETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314171 ANEURX STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention