BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX STENT GRAFT SYSTEM

    MDR report key: 5648383 · Received May 11, 2016

    Report

    Report Number
    2953200-2016-00989
    Event Type
    Injury
    Date Received
    May 11, 2016
    Date of Event
    January 1, 2001
    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; INCREASED FLEXIBILITY OF ANEURX STENT-GRAFT REDUCES NEED FOR SECONDARY INTERVENTION FOLLOWING ENDOVASCULAR ANEURYSM REPAIR FRANK R. ARKO, MD; W. ANTHONY LEE, MD; BRADLEY B. HILL, MD; PAUL CIPRIANO, MD; THOMAS J. FOGARTY, MD; AND CHRISTOPHER K. ZARINS, MD (J ENDOVASC THER 2001;8:583-59) ANEURX STENT GRAFT SYSTEMS WERE IMPLANTED IN THE PATIENTS FOR THE ENDOVASCULAR TREATMENT OF ABDOMINAL ANEURYSM REPAIR. THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: SURGICAL CONVERSION, PROXIMAL TYPE I ENDOLEAK, TYPE III SEPARATION ENDOLEAK, MIGRATION, DISTAL TYPE I ENDOLEAK, POSITIONING DIFFICULTIES. PURPOSE: TO EVALUATE THE IMPACT OF A CHANGE IN THE MANUFACTURING OF THE ANEURX STENT GRAFT ON THE LONG-TERM RESULTS OF ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM (AAA) REPAIR. METHODS: THE FIRST 70 AAA PATIENTS TREATED WITH THE ANEURX STENT-GRAFT BETWEEN OCTOBER 1996 AND DECEMBER 1998 WERE REVIEWED. THE EARLY STIFF BIFURCATED DESIGN (STIFF) WAS USED IN 23 PATIENTS (MEAN AGE 71.7 6 9.3 YEARS, RANGE 45-87) AND THE CURRENT FLEXIBLE BIFURCATED DESIGN (FLEX) IN 47 MEAN AGE 75.0 6 7.3 YEARS, RANGE 61-96). DATA ON PATIENT DEMOGRAPHICS, ANEURYSM MORPHOLOGY, TECHNICAL SUCCESS, COMPLICATIONS, SECONDARY PROCEDURES, AND OUTCOMES WERE COMPARED USING KAPLAN-MEIER ESTIMATES TO EVALUATE PATIENT SURVIVAL AND FREEDOM FROM SURGICAL CONVERSION, RUPTURE, AND SECONDARY INTERVENTIONS AT 6, 12, AND 24 MONTHS. RESULTS: THE 2 GROUPS WERE EQUALLY MATCHED WITH REGARD TO AGE, PREOPERATIVE COMORBIDITIES, PROXIMAL NECK DIMENSIONS, AND ANEURYSM DIAMETER. MEAN FOLLOW-UP TIMES WERE 22.42 6 11.72 MONTHS (RANGE 1-46) FOR THE STIFF COHORT AND 18.08 6 6.14 MONTHS (RANGE 1-30) FOR THE FLEX (P 5 0.057). ELEVEN (48%) OF 23 STIFF PATIENTS REQUIRED SECONDARY INTERVENTIONS VERSUS 6 (13%) OF 47 FLEX PATIENTS (P, 0.05). THERE WERE NO RUPTURES. AT THE 24-MONTH INTERVAL, SURVIVAL ESTIMATES WERE 86% FOR STIFF AND 76% FOR FLEX (P 5 NS); FREEDOM FROM SURGICAL CONVERSION WAS 100% FOR STIFF AND 97% FOR FLEX (P 5 NS) AND FREEDOM FROM SECONDARY INTERVENTIONS WAS 18% FOR STIFF AND 90% FOR FLEX (P, 0.05) AT 24 MONTHS. CONCLUSIONS: THE ANEURX STENT-GRAFT WAS EFFECTIVE IN ACHIEVING THE PRIMARY OBJECTIVE OF PREVENTING ANEURYSM RUPTURE IN ALL PATIENTS. HOWEVER, INCREASING THE FLEXIBILITY OF THE BIFURCATED MODULE SIGNIFICANTLY IMPROVED THE PRIMARY SUCCESS RATE BY REDUCING THE NEED FOR SUBSEQUENT SECONDARY INTERVENTIONS HYPERTENSION, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, CONGESTIVE HEART FAILURE, DIABETES, CORONARY ARTERY DISEASE, CEREBRAL VASCULAR DISEASE, PERIPHERAL VASCULAR DISEASE, CHRONIC RENAL FAILURE, DYSRHYTHMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301089 ANEURX STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention