BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 3131688 · Received May 29, 2013

    Report

    Report Number
    1058196-2013-00150
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    June 6, 2012
    Report Date
    May 9, 2013
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THE ACTUAL PRODUCT CATALOG AND LOT NUMBER ARE UNKNOWN, THEREFORE THE PRODUCT CAPTURED REPRESENTS AN UNKNOWN ENTERPRISE VRD. THE PRODUCT REMAINS IMPLANTED AND IS NOT AVAILABLE FOR ANALYSIS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    DURING COIL EMBOLIZATION OF A RUPTURED ANTERIOR COMMUNICATING ARTERY ANEURYSM A SMALL COIL CAME OUT OF THE ANEURYSM AND MIGRATED INTO NORMAL SEGMENT OF THE LEFT ANTERIOR CEREBRAL ARTERY (ACA) OCCLUDING THE LEFT ACA. ATTEMPTS AT RETRIEVING THE MIGRATED COIL WERE NOT SUCCESSFUL. IN ORDER TO RESTORE FLOW IN THE LEFT ACA AN ENTERPRISE STENT (ES) (CATALOG AND LOT UNK) WAS USED OFF LABEL TO TACK THE COIL AGAINST THE ARTERY WALL. FLOW IN THE ACA WAS RESTORED BY USING THE ES. THE PATIENT HAD A SMALL STROKE AS A RESULT. CONSENT FOR THE ES WAS OBTAINED FROM THE PATIENTS WIFE IMMEDIATELY AFTER THE PROCEDURE. IN FOLLOW UP HE WAS DOING WELL. THE LOT NUMBER WAS NOT AVAILABLE TO CONDUCT DHR REVIEW, AND THE PRODUCT WAS NO RETURNED FOR ANALYSIS. AFTER IT WAS INSERTED IN THE PATIENT, AN UNKNOWN COIL UNRAVELED AND TO SECURE THE SECTION, AN ENTERPRISE STENT WAS USED OFF LABELED. AFTERWARDS, THE PATIENT HAD A STROKE. WITH THE INFORMATION AVAILABLE AND WITHOUT THE PRODUCT AVAILABLE FOR ANALYSIS THE COMPLAINTS COULD NOT BE CONFIRMED. INSPECTIONS ARE IN PLACE TO PREVENT DAMAGED PRODUCTS FROM LEAVING THE FACILITY. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. IT IS DIFFICULT TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT BASED ON THE LIMITED INFORMATION AVAILABLE. HOWEVER, THERE ARE POSSIBLE PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THE EVENTS. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKING AT THIS TIME.

    Description of Event or Problem · 1

    DURING COIL EMBOLIZATION OF A RUPTURED ANTERIOR COMMUNICATING ARTERY ANEURYSM A SMALL COIL CAME OUT OF THE ANEURYSM AND MIGRATED INTO NORMAL SEGMENT OF THE LEFT ANTERIOR CEREBRAL ARTERY (ACA) OCCLUDING THE LEFT ACA. ATTEMPTS AT RETREIVING THE MIGRATED COIL WERE NOT SUCCESSFUL. IN ORDER TO RESTORE FLOW IN THE LT ACA AN ENTERPRISE STENT (ES) (CATLOG AND LOT UNK) WAS USED OFF LABEL TO TACK THE COIL AGAINST THE ARTERY WALL. FLOW IN THE ACA WAS RESTORED BY USING THE ES. THE PATIENT HAD A SMALL STROKE AS A RESULT. CONSENT FOR THE ES WAS OBTAINED FROM THE PATIENTS WIFE IMMEDIATELY AFTER THE PROCEDURE. IN FOLLOW UP HE WAS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237497 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM CNV ENTERPRISE SES (NJE) NJE CORDIS NEUROVASCULAR, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening UNKNOWN COIL