BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 5325745 · Received December 23, 2015

    Report

    Report Number
    1058196-2015-00225
    Event Type
    Injury
    Date Received
    December 23, 2015
    Date of Event
    September 1, 2015
    Report Date
    December 1, 2015
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NEITHER THE CATALOGUE NUMBER NOR THE LOT NUMBER WAS AVAILABLE THUS NEITHER DHR REVIEW NOR FAILURE ANALYSIS COULD BE COMPLETED. THROMBOEMBOLISM IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE USE OF THE ENTERPRISE VRD DEVICE AND IS LISTED IN THE IFU AS SUCH ALONG WITH LITERATURE DETAILING THE RECOMMENDED ANTI-CLOTTING MEDICATIONS FOR USE WITH THE DEVICE. ALL PRODUCTS UNDERGO A 100% INSPECTION PRIOR TO LEAVING THE FACILITY FOR MARKETING. REVIEW OF THE LIMITED INFORMATION SUGGESTS THAT PATIENT AND MEDICATION FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS.

    Description of Event or Problem · 1

    IN THE LITERATURE ARTICLE "CLINICAL AND ANGIOGRAPHIC OUTCOMES OF ANEURYSMS TREATED WITH TWO SELF-EXPANDING STENT-ASSISTED COILING SYSTEMS: A COMPARISON OF SOLITAIRE AB AND ENTERPRISE VRD STENTS" BY SUNG-WON KIM, SENG-OUN SUNG, KIL-SUNG CHAE, HWA-SEUNG PARK, AND SANG-HOON LEE, PUBLISHED JOURNAL OF CEREBROVASCULAR AND ENDOVASCULAR NEUROSURGERY, HTTP://DX.DOI.ORG/10.7461/JCEN.2015.17.3.149, IT WAS REPORTED THAT DURING THE INDEX PROCEDURE AFTER UNKNOWN ENTERPRISE VRD IMPLANTATION THERE WERE 2 (TWO) EVENTS OF THROMBOEMBOLISM WITHOUT LASTING EFFECT ON EITHER PATIENT. THE PURPOSE OF THIS STUDY WAS TO COMPARE CLINICAL FINDINGS AND OUTCOMES OF ENTERPRISE AND SOLITAIRE STENT-ASSISTED COILING (SAC). BETWEEN JANUARY 2012 AND MARCH 2014, 86 PATIENTS (MEAN AGE, 60.3 YEARS) HARBORING 89 ANEURYSMS WERE TREATED WITH ENTERPRISE (N = 57) OR NON-CODMAN (N = 32) SAC. THE PATIENTS' DEMOGRAPHICS, ANGIOGRAPHIC RESULTS, AND CLINICAL OUTCOMES WERE REVIEWED RETROSPECTIVELY. EIGHTY-NINE ANEURYSMS IN 86 PATIENTS QUALIFIED FOR TREATMENT WITH SAC (57 IN THE ENTERPRISE STENT GROUP AND 32 IN THE NON-CODMAN STENT GROUP). OVERALL, THE PATIENT COHORT INCLUDED 19 MEN AND 67 WOMEN. THE MEAN AGE OF PATIENTS WAS 60.3 YEARS (RANGE, 41-89 YEARS). HEADACHE WAS THE MOST COMMON SYMPTOM OF ANEURYSMS AT PRESENTATION. ALL ANEURYSMS WERE TREATED SUCCESSFULLY WITH SAC, WITHOUT PROCEDURAL COMPLICATIONS. WE OBSERVED THREE CASES (3.37%) OF THROMBOEMBOLIC EVENTS, ALL OF WHICH OCCURRED IN RUPTURED ANEURYSMS, 2 EVENTS IN THE ENTERPRISE COHORT AND 1 IN THE NON-CODMAN COHORT. AT THE TIME OF COMPLAINT ENTRY THERE IS NO CATALOGUE OR LOT NUMBER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848554 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| S