BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 5095739 · Received September 22, 2015

    Report

    Report Number
    1058196-2015-00180
    Event Type
    Malfunction
    Date Received
    September 22, 2015
    Date of Event
    May 7, 2013
    Report Date
    August 31, 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 Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO CATALOGUE OR STERILE LOT NUMBER INFORMATION AVAILABLE THUS NO DHR COULD BE PERFORMED. RECANALIZATION OF THE TARGET ANEURYSM IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE USE OF EMBOLIZATION COILS AND IS LISTED IN THE IFU AS SUCH. ALL PRODUCTS UNDERGO A 100% INSPECTION PRIOR TO BEING RELEASED FOR SALE; THERE IS NO EVIDENCE OF A MANUFACTURING ISSUE RELATED TO THIS COMPLAINT. REVIEW OF THE AVAILABLE INFORMATION SUGGESTS THAT TARGET SITE CHARACTERISTICS AND PATIENT FACTORS MAY HAVE CONTRIBUTED THE REPORTED EVENT. UDI: UNKNOWN PART NUMBER, DEVICE WAS IMPLANTED AND NOT RETURNED, UDI UNAVAILABLE. THIS REPORT IS RELATED TO MFR REPORT # 2954740-2015-00214.

    Description of Event or Problem · 1

    THE LITERATURE ARTICLE " ARTERIAL OCCLUSION TO TREAT BASILAR ARTERY DISSECTING ANEURYSM" BY QING KE CUI, WEI DONG LIU, PENG LIU, XUE YUAN LI, LIAN QUN ZHANG, LONG JIA MAB, YUN FEI REN, YA PING WUC,D, ZHI GANG WANGA, PUBLISHED NEUROLOGIAI NEUROCHIRURGIA POLSKA 49(2015) 99 - 106, REPORTS THAT ONE PATIENT, (B)(6) YEAR-OLD MALE, SUFFERED TRANSIENT NUMBNESS AND WEAKNESS ON THE RIGHT LIMBS. CEREBRAL ANGIOGRAPHY INDICATED BASILAR ARTERY DISSECTING ANEURYSM. THE PATIENT UNDERWENT THE STENT-ASSISTED COIL EMBOLIZATION OF ANEURYSM, WITH AN UNKNOWN STENT AND CODMAN MICROCOILS, AND THE RESULT WAS SATISFACTORY. DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) REVIEWS WERE PERFORMED AT 1 MONTH AND 4.5 MONTHS, RESPECTIVELY AFTER THE OPERATION AND INDICATE THAT THE BASILAR ARTERY IS UNOBSTRUCTED AND THERE WAS NO RECURRENCE OF THE ANEURYSM. DSA REVIEW DONE (B)(6) 2012, 1 YEAR AFTER THE FIRST TREATMENT INDICATES THE ANEURYSM RECURRENCE, STENT-ASSISTED COILS DENSE EMBOLIZATION, USING TWO ENTERPRISE STENTS AND CODMAN MICROCOILS, OF THE ANEURYSM WAS PERFORMED AGAIN AND THE RESULT WAS SATISFACTORY. TEN MONTHS AFTER THE SECOND OPERATION ON (B)(6) 2013, DSA REVIEW FOUND THE BASILAR ARTERY ANEURYSM RECURRENCE AGAIN AND OCCLUSION OF THE BASILAR ARTERY WAS PERFORMED USING FURTHER CODMAN MICROCOILS. THE BASILAR ARTERY OCCLUSION WAS EFFECTIVE. THE BILATERAL POSTERIOR INFERIOR CEREBELLAR ARTERIES AND THE BILATERAL POSTERIOR CEREBRAL ARTERIES ARE UNOBSTRUCTED. FIVE MONTHS OF FOLLOW- UP FOUND THAT THE PATIENT RECOVERED WELL. DSA REVIEWS PERFORMED 5 MONTHS AFTER OCCLUSION INDICATE NO RECURRENCE OF THE ANEURYSM. THE OBJECT WAS TO EXPLORE THE CLINICAL FEASIBILITY OF EMPLOYING OCCLUSION TO TREAT BASILAR ARTERY DISSECTING ANEURYSM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626916 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM CNV ENTERPRISE SES (NJE) NJE CODMAN AND SHURTLEFF, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R