BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX STENT GRAFT SYSTEM

    MDR report key: 5658046 · Received May 16, 2016

    Report

    Report Number
    2953200-2016-01044
    Event Type
    Injury
    Date Received
    May 16, 2016
    Date of Event
    June 14, 2007
    Report Date
    April 29, 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
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    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; LONG-TERM SINGLE-CENTER RESULTS WITH ANEURX ENDOGRAFTS FOR ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR. JOOST A. VAN HERWAARDEN, MD, PHD "; ERIC D.W.M. VAN DE PAVOORDT, MD, EVERT J. WAASDORP, MD; JAN ALBERT VOS, MD; TIM THC. OVERTOOM, MD; JOHANNES C. KELDER, MD; FRANS L MOLL, MD, PHD"; AND JEAN-PAUL P.M. DE VRIES, MD, THE NETHERLANDS. AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF ENDOVASCULAR REPAIR. DURING THE RETROSPECTIVE STUDY THE FOLLOWING ADVERSE EVENTS WERE OBSERVED: TYPE IA, MIGRATION, RUPTURE. PURPOSE: TO EVALUATE THE LONG-TERM SINGLE-CENTER RESULTS WITH THE ANEURX STENT-GRAFT IN ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM (AAA) REPAIR (EVAR). METHODS: BETWEEN DECEMBER 1996 AND AUGUST 2003, 212 PATIENTS (197 MEN; MEAN AGE 71.3+/-7.0 YEARS) WERE TREATED WITH THE ANEURX STENT-GRAFT FOR AN INFRARENAL AAA. POSTOPERATIVELY, PATIENTS WERE ENROLLED IN A FIXED SURVEILLANCE PROTOCOL, AND DATA WERE PROSPECTIVEIY CAPTURED INTO A DATABASE. RESUITS: GRAFT DEPLOYMENT WAS SUCCESSFUL IN 98.6% (209/212). THIRTY-DAY MORTALITY WAS 2.4%. MEDIAN HOSPITAL STAY WAS 4.3ᵮ5 DAYS. MEDIAN FOLLOW-UP WAS 52.0 MONTHS (RANGE 1-109); ONLY 1 PATIENT WAS LOST TO FOLLOW-UP. AT 9 YEARS, PATIENT SURVIVAL WAS 56% AND FREEDOM FROM SECONDARY INTERVENTIONS WAS 48%. IN 68% OF CASES, THESE REINTERVENTIONS WERE NEEDED FOR A FIXATION-RELATED COMPLICATION, AND MOST OF THESE COMPLICATIONS (75%) ENCOMPASSED THE AREA OF THE PROXIMAL ANEURYSM NECK. PRIMARY CLINICAL SUCCESS WAS 37% AT 9 YEARS. AFTER SECONDARY INTERVENTIONS, THE ASSISTED PRIMARY CLINICAL SUCCESS IMPROVED TO 73% AT 9 YEARS. FREEDOM FROM ANEURYSM-RELATED DEATH WAS 97% AT 1 YEAR AND 90% AT 9 YEARS. CONCLUSION: AS AN ALTERNATIVE TO OPEN REPAIR, EVAR WITH THE ANEURX DEVICE HAS LOW PERIOPERATIVE MORTALITY. REINTERVENTIONS ARE MOSTLY DUE TO FIXATION-RELATED COMPLICATIONS. WHILE THE OVERALL MORTALITY RISK IN THIS POPULATION WAS 5% PER YEAR, ANNUAL ANEURYSMRELATED DEATH WAS ONLY 1%. THE FOCUS SHOULD BE ON SURVEILLANCE AND REDUCING THE RATE OF LONG-TERM COMPLICATIONS, WHICH MIGHT BE POSSIBLE WITH IMPROVED PROXIMAL STENT-GRAFT FIXATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312916 ANEURX STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR SANTA ROSA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention