BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANEURX

    MDR report key: 3698735 · Received March 25, 2014

    Report

    Report Number
    2953200-2014-00586
    Event Type
    Malfunction
    Date Received
    March 25, 2014
    Date of Event
    January 1, 2013
    Report Date
    March 7, 2014
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS OBTAINED FROM A JOURNAL ARTICLE. VASCULAR ENDOSTAPLING SYSTEMS FOR VASCULAR ENDOGRAFTS (T)EVAR-SYSTEMATIC REVIEW-CURRENT STATE BAIL, D., WALKER, T., GIEHL, J. VASCULAR AND ENDOVASCULAR SURGERY 2013 47(4) 261-266 DOI: 10.1177/1538574413478474 ABSTRACT PURPOSE: RECENTLY, VASCULAR ENDOSTAPLING SYSTEMS WERE DEVELOPED TO ACHIEVE BETTER SEALING AT THE PROXIMAL NECK OF THE ANEURYSM AND TO PREVENT ENDOGRAFT MIGRATION. THE PURPOSE OF THIS STUDY WAS TO PROVIDE A SYSTEMATIC REVIEW ABOUT THE CURRENT STATE AND POSSIBLE OPTIONS OF VASCULAR ENDOSTAPLING SYSTEMS. RESULTS: NO RANDOMIZED CONTROLLED TRIALS WERE PUBLISHED. THE RESULTS SHOWED THAT THE USE OF AN ENDOSTAPLE SYSTEM CONSIDERABLY REDUCED THE RATES OF ENDOLEAKS TYPE 1A AND ENDOGRAFT MIGRATION. REGARDING THE USE OF ENDOSTAPLES IN DIFFERENT TYPES OF ENDOGRAFTS, ONLY A FEW RESULTS WERE AVAILABLE. CONCLUSION: THE RESULTS ARE NOT CONCLUSIVE. WITH ENDOSTAPLE SYSTEMS, PATIENTS WITH DIFFICULT ANATOMIC FEATURES AND HIGH RISK CAN POTENTIALLY BE TREATED. THESE SYSTEMS MIGHT REDUCE THE HIGH REINTERVENTION RATES AFTER ENDOVASCULAR ANEURYSM REPAIR. CONTROLLED RANDOMIZED TRIALS WITH LARGER NUMBER OF PATIENTS ARE WARRANTED WITH ENDOSTAPLING USE IN PRIMARY ENDOGRAFT IMPLANTATION AND FOR USE IN REINTERVENTION FOR LATE ENDOLEAKS OR ENDOGRAFT MIGRATIONS. THE FOLLOWING EVENTS WERE REPORTED: STENT GRAFT MIGRATION, ENDOLEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175151 ANEURX SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1