BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 4252461 · Received November 14, 2014

    Report

    Report Number
    1058196-2014-00284
    Event Type
    Injury
    Date Received
    November 14, 2014
    Date of Event
    September 23, 2014
    Report Date
    December 11, 2014
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED AND WILL NOT BE RETURNED FOR ANALYSIS. NO LOT NUMBER WAS PROVIDED; THEREFORE, NO GTIN NUMBER WAS AVAILABLE.

    Additional Manufacturer Narrative · 1

    AS REPORTED VIA A LITERATURE ARTICLE (KONO, K, ET AL. SEPTEMBER 23, 2014. ¿HEMODYNAMIC EFFECTS OF STENT STRUTS VERSUS STRAIGHTENING OF VESSELS IN STENT-ASSISTED COIL EMBOLIZATION FOR SIDEWALL CEREBRAL ANEURYSM¿, PLOS ONE. 2014 SEP 23; 9(9):E108033.), ONE PATIENT WAS EXCLUDED FROM A RETROSPECTIVE STUDY TO ASSESS AND COMPARE THE HEMODYNAMIC EFFECT OF STENT STRUTS AND STRAIGHTENING OF VESSELS DUE TO POST-OPERATIVE IN-STENT STENOSIS OF AN UNSPECIFIED ENTERPRISE STENT AND ONE PATIENT WAS EXCLUDED DUE TO POST-OPERATIVE IN-STENT OCCLUSION OF AN UNSPECIFIED ENTERPRISE STENT. NO ADDITIONAL INFORMATION REGARDING THE PATIENTS, PROCEDURES, OR EVENTS WAS PROVIDED IN THE ARTICLE. THE DEVICE WAS NOT RETURNED FOR ANALYSIS, AND THE LOT NUMBER WAS NO AVAILABLE TO CONDUCT LOT HISTORY REVIEW. STENOSIS OF THE STENTED SEGMENT IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE USE OF THE ENTERPRISE VRD AS OUTLINED IN THE INSTRUCTIONS FOR USE. UNDERLYING PATIENT AND PROCEDURAL FACTORS MAY PLAY A ROLE; HOWEVER, BASED ON THE AVAILABLE INFORMATION, NO CONCLUSION CAN BE MADE REGARDING POSSIBLE CONTRIBUTING FACTORS. THERE IS NO INDICATION OF ANY MANUFACTURING ISSUES RELATED TO THE EVENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN.

    Description of Event or Problem · 1

    AS REPORTED VIA A LITERATURE ARTICLE (KONO, K, ET AL. SEPTEMBER 23, 2014. ¿HEMODYNAMIC EFFECTS OF STENT STRUTS VERSUS STRAIGHTENING OF VESSELS IN STENT-ASSISTED COIL EMBOLIZATION FOR SIDEWALL CEREBRAL ANEURYSM¿, PLOS ONE. 2014 SEP 23; 9(9):E108033.), ONE PATIENT WAS EXCLUDED FROM A RETROSPECTIVE STUDY TO ASSESS AND COMPARE THE HEMODYNAMIC EFFECT OF STENT STRUTS AND STRAIGHTENING OF VESSELS DUE TO POST-OPERATIVE IN-STENT STENOSIS OF AN UNSPECIFIED ENTERPRISE STENT AND ONE PATIENT WAS EXCLUDED DUE TO POST-OPERATIVE IN-STENT OCCLUSION OF AN UNSPECIFIED ENTERPRISE STENT. NO ADDITIONAL INFORMATION REGARDING THE PATIENTS, PROCEDURES, OR EVENTS WAS PROVIDED IN THE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736339 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM CNV ENTERPRISE SES (NJE) NJE CODMAN AND SHURTLEFF, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening