BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 4241380 · Received November 10, 2014

    Report

    Report Number
    1058196-2014-00279
    Event Type
    Injury
    Date Received
    November 10, 2014
    Date of Event
    September 15, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS REPORTED VIA AN ABSTRACT (KATSUNARI, ET AL. SEP 15, 2014. ¿OCULAR THROMBOSIS AFTER STENT-ASSISTED COILING OF A C7 (PARACLINOID) INTERNAL CAROTID ARTERY ANEURYSM. A REPORT OF TWO CASES AND LITERATURE REVIEW¿, INTERV NEURORADIOL. 2014 SEP15; 20(4):455-60. DOI: 10.15274/NRJ-2014-10034), TWO PATIENTS DEVELOPED OCULAR THROMBOEMBOLISM FOLLOWING AN STENT-ASSISTED COILING OF PARACLINOID ANEURYSM WITH USE OF AN UNSPECIFIED ENTERPRISE STENT. NO ADDITIONAL INFORMATION REGARDING THE PATIENTS, PROCEDURES, OR EVENTS WAS PROVIDED IN THE ABSTRACT. THE ARTICLE WAS NOT AVAILABLE. THE DEVICE WAS NOT RETURNED FOR ANALYSIS, AND THE LOT NUMBER WAS NO AVAILABLE TO CONDUCT LOT HISTORY REVIEW. THROMBOEMBOLISM IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE USE OF THE ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM, AS OUTLINED IN THE INSTRUCTIONS FOR USE. BASED ON THE LIMITED INFORMATION, THERE IS NO INDICATION OF ANY DEVICE PERFORMANCE OR MANUFACTURING ISSUES RELATED TO THE REPORTED EVENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE PRODUCT NOTED IN THE REPORT IS FOR AN UNKNOWN ENTERPRISE. ALSO, THIS REPORT IS FOR (B)(4). ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF REPORT.

    Description of Event or Problem · 1

    AS REPORTED VIA AN ABSTRACT (KATSUNARI, ET AL. SEP 15, 2014. ¿OCULAR THROMBOSIS AFTER STENT-ASSISTED COILING OF A C7 (PARACLINOID) INTERNAL CAROTID ARTERY ANEURYSM. A REPORT OF TWO CASES AND LITERATURE REVIEW¿, INTERV NEURORADIOL. 2014 SEP15; 20(4):455-60. DOI: 10.15274/NRJ-2014-10034), TWO PATIENTS DEVELOPED OCULAR THROMBOEMBOLISM FOLLOWING AN STENT-ASSISTED COILING OF PARACLINOID ANEURYSM WITH USE OF AN UNSPECIFIED ENTERPRISE STENT. NO ADDITIONAL INFORMATION REGARDING THE PATIENTS, PROCEDURES, OR EVENTS WAS PROVIDED IN THE ABSTRACT. THE ARTICLE WAS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    721693 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM CNV ENTERPRISE SES (NJE) NJE CODMAN AND SHURTLEFF, INC UNKENTERPRISEENC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening