BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 3781397 · Received April 30, 2014

    Report

    Report Number
    1058196-2014-00130
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    October 1, 2013
    Report Date
    April 4, 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

    (B)(4) MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01424664. 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. THIS PACKAGING LOT CONTAINED 200 UNITS, WHICH WERE SHIPPED FROM (B)(4) MEDICAL ON (B)(4) 2010. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. IT SHOULD BE NOTED THAT THE REPORTED LOT HAS A USE BY DATE OF 2011-06, AS INDICATED IN THE DEVICE HISTORY RECORDS. THIS IS REPORT 2 OF 2 RELATED TO (B)(4).

    Additional Manufacturer Narrative · 1

    WITH FOLLOW-UP INVESTIGATION IT WAS REPORTED THAT THE THROMBOEMBOLIC CASE WAS NOT DIRECTLY RELATED TO THE ENTERPRISE STENT; HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE. THE STENTS REMAIN IMPLANTED AND THEREFORE ARE NOT AVAILABLE FOR ANALYSIS. LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01425622 AND 01424664. THE DEVICE HISTORY RECORDS REVIEW ALSO INCLUDED A REVIEW OF THE CERTIFICATES 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 THESE LOTS. THE HISTORY RECORDS INDICATE THESE PRODUCTS WERE FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WERE DETERMINED TO BE ACCEPTABLE. THE ADVERSE EVENT OF THROMBOTIC EMBOLI IS A KNOWN POTENTIAL OCCURRENCE ASSOCIATED WITH THE USE OF THE ENTERPRISE VRD AND THE PROCEDURES THEY ARE USED IN 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. USAGE OTHER THAN THE APPROVED LABELING MAY INVOLVE RISKS NOT DESCRIBED IN THE LABELING. IT IS POSSIBLE THAT CLINICAL, PROCEDURAL, PHARMACOLOGICAL FACTORS MAY HAVE IMPACTED THE EVENT. WITH REVIEW OF THE AVAILABLE INFORMATION AND THE DEVICE HISTORY RECORDS THERE IS NO INDICATION OF ANY DEVICE PERFORMANCE OR MANUFACTURING 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 # 19) EXPERIENCED A PROCEDURAL COMPLICATION OF ASYMPTOMATIC THROMBOEMBOLISM AFTER STENT-ASSISTED COILING OF AN UNRUPTURED BASILAR TIP ARTERY ANEURYSM. TWO ENTERPRISE STENTS (ENF452812/01425622) AND (ENF452212/01424664) WERE IMPLANTED BY Y STENT TECHNIQUE, AND NON-CODMAN COILS WERE USED FOR THE PROCEDURE. TREATMENT FOR THE THROMBOEMBOLISM WAS NOT IDENTIFIED IN THE ARTICLE. THE ANEURYSM WAS 10.7MM AND THE SACK TO NECK RATIO WAS 1.4MM. CLOPIDOGREL 75MG DAILY AND ASPIRIN 100MG DAILY WERE STARTED 5 TO 7 DAYS PRIOR TO THE PROCEDURE. ON THE DAY BEFORE TREATMENT, PATIENTS WERE GIVEN A LOADING DOSE OF CLOPIDOGREL 300MG AND ASPIRIN 100MG IF ANTIPLATELET THERAPY WAS NOT GIVEN. ANTICOAGULATION WAS PROVIDED WITH AN INJECTION OF A 300-4000 IU BOLUS OF HEPARIN INTRAVENOUSLY AT THE BEGINNING OF THE PROCEDURE, FOLLOWED BY CONTINUOUS INFUSION OF HEPARIN AT 1000 IU/HOUR. ACTIVATED COAGULATION TIME WAS MAINTAINED BETWEEN TWO AND THREE TIMES THE BASELINE VALUES DURING THE PROCEDURE AND 24 TO 48 HOURS AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260826 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM CNV ENTERPRISE SES (NJE) NJE CORDIS NEUROVASCULAR, INC. NA 01424664

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention