BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 3231710 · Received July 17, 2013

    Report

    Report Number
    1058196-2013-00190
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Report Date
    June 24, 2013
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATALOGUE AND LOT WERE NOT KNOWN; THEREFORE, THE PRODUCT REFLECTED IS AN UNKNOWN ENTERPRISE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THERE WAS STENOSIS OF THE DISTAL END OF THE ENTERPRISE VRD (ENC452812/LOT UNK) FOUR MONTHS AFTER IT WAS IMPLANTED. ADDITIONALLY, DURING THE INDEX PROCEDURE, AFTER DEPLOYMENT OF THE VRD, THE STABILIZER WIRE (DELIVERY SYSTEM) FRACTURED/SEPARATED INTO TWO PIECES AND REMAINED AT THE TARGET SITE. DURING THE INITIAL PLACEMENT OF THE STENT THERE WAS A MINIMUM ON 5MM BEYOND THE ANEURYSM NECK. THERE WAS NO MIGRATION DURING THE PROCEDURE, AND THE STENTS COVERED THE ANEURYSM NECK. THERE WAS NO SIGNIFICANT VESSEL SPASM, NOR ASSOCIATED PATIENT ADVERSE EVENT NOTED. THE TARGET LESION WAS AN ACOM ANEURYSM AFTER SAH TREATED WITH TWO STENTS (NEUROFORM EZ 3X20 AND ENTERPRISE 45X28) AND COILS. THE ANEURYSM WAS BROAD NECK ANEURYSM AND THE VESSEL DIAMETER WAS 2.5 ¿ 5MM PROXIMAL TO DISTAL. THE IMPLANT DATE WAS BETWEEN THE YEARS OF 2011 ¿ 2013. THE ADMITTING DIAGNOSIS WAS SAH, AND THERE ARE NO PATIENT SPECIFIC DETAILS AVAILABLE AT THIS TIME. THE PRODUCT WILL NOT BE RETURNED. THE DEVICE REMAINS IMPLANTED AND WAS NOT AVAILABLE FOR ANALYSIS. NO LOT NUMBER WAS PROVIDED AND NO DHR COULD BE CONDUCTED. STENOSIS OF THE STENTED SEGMENT IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE USE OF THE ENTERPRISE VRD AS OUTLINED IN THE INSTRUCTIONS FOR USE. UNDERLYING PATIENT AND PROCEDURAL FACTORS MAY PLAY A ROLE; HOWEVER, BASED ON THE AVAILABLE INFORMATION, NO CONCLUSION CAN BE MADE REGARDING POSSIBLE CONTRIBUTING FACTORS. THERE IS NO INDICATION OF ANY MANUFACTURING ISSUES RELATED TO THE EVENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT AN ENTERPRISE ENC (CATALOG AND LOT UNK) MIGRATED. ADDITIONAL INFORMATION WAS REQUESTED, BUT TO DATE, IT HAS NOT BEEN RECEIVED. IN THE INITIAL PLACEMENT OF THE STENT THERE WAS A MINIMUM ON 5MM BEYOND THE ANEURYSM NECK IN ALL 5 CASES. THERE WAS NO MIGRATION DURING THE PROCEDURE. THE STENTS COVERED THE ANEURYSM NECK AFTER THE MIGRATION. THERE WAS NO SIGNIFICANT VESSEL SPASM. THERE WERE NO ASSOCIATED PATIENT ADVERSE EVENTS NOTED. THE TARGET LESIONS WERE ACOM AND CAROTID ARTERY. THIS WAS A BROAD NECK ANEURYSM AND THE VESSEL DIAMETER WAS 2.5 ¿ 5MM PROXIMAL TO DISTAL. THE IMPLANT DATES WERE BETWEEN THE YEARS OF 2011 ¿ 2013. THE ADMITTING DIAGNOSIS WAS PREVIOUS SAH, RECANALIZATION OF COILED ANEURYSM. THERE ARE NO PATIENT SPECIFIC DETAILS AVAILABLE AT THIS TIME. THE STENT WAS IMPLANTED AND THE DELIVERY SYSTEM WAS NOT RETURNED FOR EVALUATION. ADDITIONALLY, THE LOT NUMBER WAS NOT PROVIDED, THEREFORE NO DHR COULD BE CONDUCTED. IT IS POSSIBLE THAT PROCEDURAL FACTORS AND VESSEL CHARACTERISTICS INCLUDING THE REPORTED ANGULATION CONTRIBUTED TO THE EVENT. HOWEVER, WITHOUT PROCEDURAL IMAGES AND BASED ON THE AVAILABLE INFORMATION, NO CONCLUSION CAN BE MADE REGARDING THE MIGRATION. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THIS INFORMATION WAS RECEIVED (B)(6) 2013 BUT WAS INADVERTENTLY OVERLOOKED. IT WAS REPORTED THAT THERE WAS STENOSIS OF THE DISTAL END OF THE ENTERPRISE VRD ((B)(4)/LOT UNK) FOUR MONTHS AFTER IT WAS IMPLANTED. ADDITIONALLY, DURING THE INDEX PROCEDURE, AFTER DEPLOYMENT OF THE VRD, THE STABILIZER WIRE (DELIVERY SYSTEM) FRACTURED/SEPARATED INTO TWO PIECES AND REMAINED AT THE TARGET SITE. DURING THE INITIAL PLACEMENT OF THE STENT THERE WAS A MINIMUM ON 5MM BEYOND THE ANEURYSM NECK. THERE WAS NO MIGRATION DURING THE PROCEDURE, AND THE STENTS COVERED THE ANEURYSM NECK. THERE WAS NO SIGNIFICANT VESSEL SPASM, NOR ASSOCIATED PATIENT ADVERSE EVENT NOTED. THE TARGET LESION WAS AN ACOM ANEURYSM AFTER SAH TREATED WITH TWO STENTS (NEUROFORM EZ 3X20 AND ENTERPRISE 45X28) AND COILS. THE ANEURYSM WAS BROAD NECK ANEURYSM AND THE VESSEL DIAMETER WAS 2.5 ¿ 5MM PROXIMAL TO DISTAL. THE IMPLANT DATE WAS BETWEEN THE YEARS OF 2011 ¿ 2013. THE ADMITTING DIAGNOSIS WAS SAH, AND THERE ARE NO PATIENT SPECIFIC DETAILS AVAILABLE AT THIS TIME. THE PRODUCT WILL NOT BE RETURNED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ENTERPRISE ENC (CATALOG AND LOT UNK) MIGRATED. ADDITIONAL INFORMATION WAS REQUESTED, BUT TO DATE, IT HAS NOT BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330764 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM CNV ENTERPRISE SES (NJE) NJE CORDIS NEUROVASCULAR, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1