BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 1801364 · Received August 16, 2010

    Report

    Report Number
    1058196-2010-00224
    Event Type
    Injury
    Date Received
    August 16, 2010
    Date of Event
    April 1, 2010
    Report Date
    July 22, 2010
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    NJE
    PMA / PMN Number
    HDE H60001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT AFTER FURTHER INFORMATION WAS RECEIVED, IT WAS DETERMINED THAT THE EVENT DOES NOT MEET THE REPORTING CRITERIA FOR EITHER ADVERSE EVENT OR PRODUCT MALFUNCTION. NO FURTHER REPORTS WILL BE SUBMITTED FOR THIS EVENT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE EMAIL RECEIVED FOR THE (B)(4) INDICATED THAT 5 HOURS POST-PROCEDURE, THE PATIENT (2-16) EXPERIENCED TRANSIENT RIGHT HEMIPARESIS WITH A MODIFIED RANKIN SCALE (MRS) OF 3- MODERATE DISABILITY, REQUIRES SOME HELP, BUT ABLE TO WALK WITHOUT ASSISTANCE. THE EVENT WAS NOT PROCEDURE RELATED AND NO TREATMENT WAS CONDUCTED. THE PATIENT UNDERWENT THE PROCEDURE TO TREAT A NON RUPTURED ANEURYSM OF THE LEFT SUPRACLINOID CAROTID ARTERY WITH DIMENSIONS OF 1.9MM SAC HEIGHT, SAC WIDTH OF 2.6MM AND NECK OF 1.7MM. THE PRE-PROCEDURE WFNS AND MODIFIED RANKIN SCALE WERE BOTH 0. PRIOR TO THE STENT PLACEMENT, A BALLOON WAS USED. A 14MM ENTERPRISE VRD WAS IMPLANTED AT THE SITE AND THE PROCEDURE WAS COMPLETED WITH COMPLETE OCCLUSION OF THE ANEURYSM CONFIRMED WITH ANGIOGRAPHY. AFTER THE PROCEDURE, THE MRS WAS 0. ASPIRIN WAS GIVEN PRE AND POST PROCEDURE, OTHER ANTIPLATELETS WERE GIVEN PRE, INTRA, AND POST PROCEDURE, AND HEPARIN WAS GIVEN INTRA-PROCEDURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Disability