BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 3688407 · Received March 19, 2014

    Report

    Report Number
    1058196-2014-00089
    Event Type
    Injury
    Date Received
    March 19, 2014
    Date of Event
    October 1, 2013
    Report Date
    February 21, 2014
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION OBTAINED (4/4/2014): THE CATALOG AND LOT NUMBER WAS OBTAINED FOR THE SUSPECT PRODUCTS IN THIS COMPLAINT.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT HE FOCAL STENOSIS (CASE 20) OF THE LEFT PROXIMAL P1 SEGMENT NEAR THE NECK WAS INTIMAL HYPERPLASIA AND SHOWED NO SYMPTOMATIC COMPLICATION. THE ENTERPRISE VRDS REMAIN IMPLANTED AND THEREFORE ARE NOT AVAILABLE FOR ANALYSIS. LAKE REGION MEDICAL REVIEWED THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01427235. THE DEVICE HISTORY RECORD REVIEW ALSO INCLUDED A REVIEW OF THE CERTIFICATE OF CONFORMANCE RECEIVED FROM SPECIALTY COATINGS SYSTEMS AND NITINOL DEVICES AND COMPONENTS, ALONG WITH LAKE REGION MEDICAL¿S INTERNAL RECEIVING INSPECTION RECORDS FOR THE STENTS ISSUED TO THE COMPLAINT LOT. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. STENOSIS OF THE STENTED SEGMENT IS A KNOWN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF THE ENTERPRISE VRD AS OUTLINED IN THE INSTRUCTIONS FOR USE. ADDITIONALLY, THE ENTERPRISE STENTS WERE IMPLANTED IN A Y-STENTING CONFIGURATION. THE INSTRUCTIONS FOR USE OUTLINES THAT PERFORMANCE AND SAFETY OF TWO OR MORE OVERLAPPED STENTS HAS NOT BEEN ESTABLISHED. IT IS POSSIBLE THAT CLINICAL FACTORS INCLUDING PATIENT FACTORS/MEDICAL HISTORY AND OR PHARMACOLOGICAL FACTORS MAY HAVE IMPACTED THE EVENT. WITH REVIEW OF THE AVAILABLE INFORMATION AND THE DEVICE HISTORY RECORD REVIEW THERE ARE NO INDICATIONS OF ANY MANUFACTURING OR DEVICE PERFORMANCE ISSUES RELATED TO THE EVENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    AS REPORTED IN A LITERATURE ARTICLE (MYUNG, HO RHO ,ET AL. ¿VARIOUS TECHNIQUES OF STENT-ASSISTED COIL EMBOLIZATION OF WIDE-NECKED OR FUSIFORM ARTHEROSCLEROTIC AND DISSECTING UNRUPTURED VERTEBROBASILAR ARTERY ANEURYSMS FOR REDUCING RECANALIZATION: MID-TERM RESULTS¿, ACTA NEUROCHIR, (2013): 155:2009-2017) A PATIENT (PATIENT # 20) EXPERIENCED MODERATE IN-STENT STENOSIS AT THE 8-MONTH FOLLOW-UP AFTER STENT-ASSISTED COILING OF AN UNRUPTURED BASILAR TIP ANEURYSM. THE PATIENT WAS NOT SYMPTOMATIC AND THUS DID NOT REQUIRE RETREATMENT FOR THE STENOSIS. AT THE TIME OF ANEURYSM TREATMENT, TWO ENTERPRISE STENTS (LOT AND CATALOG NUMBERS UNKNOWN) WERE IMPLANTED BY Y-STENT TECHNIQUE, AND NON-CODMAN COILS WERE USED FOR THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161908 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM CNV ENTERPRISE SES (NJE) NJE CORDIS NEUROVASCULAR, INC. NA 01427235

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Disability