BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX STENT GRAFT SYSTEM

    MDR report key: 5648466 · Received May 11, 2016

    Report

    Report Number
    2953200-2016-00991
    Event Type
    Injury
    Date Received
    May 11, 2016
    Date of Event
    February 23, 2003
    Report Date
    April 26, 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
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXACT DATES OF THE EVENTS ARE UNKNOWN.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED; MORPHOLOGIC CHANGES AND OUTCOME FOLLOWING ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR AS A FUNCTION OF ANEURYSM SIZE. FRANK R. ARKO, MD; KONSTANTINO A. FILIS, MD; BRADLEY B. HILL, MD; THOMAS J. FOGARTY, MD; CHRISTOPHER K. ZARINS, MD (ARCH SURG. 2003; 138:651-656) ANEURX STENT GRAFT SYSTEM WERE IMPLANTED IN THE PATIENTS FOR THE ENDOVASCULAR TREATMENT OF ABDOMINAL ANEURYSM REPAIR. THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: ANEURYSM ENLARGEMENT, UNKNOWN ENDOLEAK, TYPE II ENDOLEAK. HYPOTHESIS: SMALL INFRARENAL ABDOMINAL AORTIC ANEURYSMS HAVE A MORE FAVORABLE CLINICAL AND MORPHOLOGIC OUTCOME COMPARED WITH MEDIUM AND LARGE ABDOMINAL AORTIC ANEURYSMS FOLLOWING ENDOVASCULAR ANEURYSM REPAIR(EVAR). DESIGN: PROSPECTIVE CLINICAL SERIES OF 206 PATIENTS UNDERGOING ELECTIVE EVAR BETWEEN 1996 AND 2001. SETTING TERTIARY CARE ACADEMIC HEALTH CENTER. PATIENTS: PATIENTS WERE GROUPED ACCORDING TO ANEURYSM SIZE: SMALL (<(> <<)>50 MM), MEDIUM (50-60 MM), AND LARGE (>60 MM). INTERVENTIONS: PRIMARY EVAR AND SECONDARY PROCEDURES TO SECURE FIXATION OF THE STENT GRAFT AND SURGICAL CONVERSIONS. MAIN OUTCOME MEASURES: ANEURYSM DIAMETER, ENDOLEAKS, AND LONG-TERM MORPHOLOGIC CHANGES WERE ANALYZED POSTOPERATIVELY WITH 3-DIMENSIONAL RECONSTRUCTIONS OF COMPUTED TOMOGRAPHIC ANGIOGRAMS. RESULTS: GROUPS WERE SIMILAR IN AGE, COMORBIDITIES, AND FOLLOW-UP (MEAN +/-D, 32.1 +/-1.8 MONTHS). THERE WERE 30 SMALL ANEURYSMS, 92 MEDIUM ANEURYSMS, AND 84 LARGE ANEURYSMS, WITH A MEAN SIZE OF 45.1 +/- 3.7 MM, 53.8 +/- 3.1 MM, AND 66.1 +/- 6.8 MM, RESPECTIVELY (P<(><<)>.01). THERE WAS NO SIGNIFICANT DIFFERENCE IN PROXIMAL NECK OR ILIAC ARTERY DIAMETER AMONG THE 3 GROUPS. THE PROXIMAL AORTIC NECK LENGTH (28.1 ± 11.6 MM [SMALL]; 23.9 ± 11.3 MM [MEDIUM]; AND 22.1 ± 11.6 MM [LARGE]; P<(> <<)>.05) WAS SIGNIFICANTLY SHORTER IN LARGE ANEURYSMS. FURTHERMORE, THERE WAS A SIGNIFICANT INCREASE (6% [SMALL]; 15% [MEDIUM]; AND 21% [LARGE]; P<(><<)>.05) IN ANGULATED NECKS IN LARGE ANEURYSMS. FOLLOWING TREATMENT, ANEURYSM DIAMETER REMAINED STABLE IN MOST PATIENTS (83% [SMALL]; 82% [MEDIUM]; AND 83% [LARGE]), WITH A MEAN DECREASE OF 2.0 ± 6.5 MM, 2.1 ±6.1 MM, AND 3.7 ± 7.7 MM IN EACH GROUP, RESPECTIVELY (P = .45). THERE WAS NO DIFFERENCE IN THE INCIDENCE OF ENDOLEAKS, ANEURYSM CONTRACTION, OR ANEURYSM EXPANSION BASED ON PREOPERATIVE ANEURYSM DIAMETER. SECONDARY PROCEDURES WERE PERFORMED IN 5 (20%) OF 25, 9 (5.2%) OF 170, AND 5 (36%) OF 11 ANEURYSMS THAT CONTRACTED, REMAINED STABLE, OR EXPANDED, RESPECTIVELY, FOLLOWING EVAR (P<(><<)>.05). CONCLUSIONS: THERE IS A 15% INCREASE IN NECK ANGULATION AND A 27% DECREASE IN NECK LENGTH IN LARGE COMPARED WITH SMALL INFRARENAL AB DOMINAL AORTIC ANEURYSMS, WITH NO DIFFERENCE IN OUTCOME. ANEURYSMS THAT ARE STABLE FOLLOWING EVAR HAVE A SIGNIFICANTLY LOWER INCIDENCE OF REQUIRING SECONDARY PROCEDURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301048 ANEURX STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention