BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 4776325 · Received May 15, 2015

    Report

    Report Number
    1058196-2015-00110
    Event Type
    Injury
    Date Received
    May 15, 2015
    Date of Event
    September 5, 2014
    Report Date
    May 18, 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
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NONE OF THE COMPLAINT DEVICES WERE AVAILABLE FOR ANALYSIS AND NO STERILE LOT NUMBER INFORMATION WAS PROVIDED THUS NO DHR COULD BE PERFORMED. CEREBRAL ANEURYSM, CEREBRAL THROMBOSIS AND CEREBRAL STENOSIS ARE ALL KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE SAC (STENT ASSISTED COILING) PROCEDURES AND ARE LISTED IN THE IFU AS SUCH. ALL PRODUCTS ARE 100% INSPECTED PRIOR TO LEAVING THE MANUFACTURING FACILITY AND THERE IS NO EVIDENCE OF A MANUFACTURING RELATED ISSUE. REVIEW OF THE AVAILABLE INFORMATION SUGGESTS THAT TARGET LESION, PARENT VESSEL, PATIENT AND PHARMACOLOGIC ISSUES MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS HOWEVER THE CONCLUSIONS ARE CURRENTLY BEING FORMULATED ABOUT THE EVENT BASED ON THE INFORMATION PROVIDED. NO CONCLUSION IS MADE AT THIS TIME. THIS IS ONE OF THREE REPORTS BASED ON THIS LITERATURE ARTICLE. THIS REPORT IS BEING SUBMITTED TO CAPTURE THE TWO EVENTS IN WHICH A PATIENT EXPERIENCED ANEURYSM GROWTH. THE OTHER TWO REPORTS RELATED TO THIS ARTICLE ARE MFR REPORTS #'S 1058196-2015-00111 AND 1058196-2015-00112. UDI: UNKNOWN PART NUMBER, ALL 3 ATTEMPTS TO OBTAIN PRODUCT WERE UNSUCCESSFUL, UDI IS UNAVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED IN THE LITERATURE ARTICLE ¿ENDOVASCULAR TREATMENT OF UNRUPTURED WIDE-NECKED INTRACRANIAL ANEURYSMS: COMPARISON OF DUAL MICROCATHETER TECHNIQUE AND STENT-ASSISTED COIL EMBOLIZATION¿ BY STARKE, R; DURST, C; EVANS, A; DING, D; RAPER, D; JENSON, M; CROWLEY, R AND LIU, K, JOURNAL OF NEUROINTERVENTIONAL SURGERY 2014; 0:1-6. DOI:10.1136/NEURINTSURG-2014-011159, THAT THERE WAS DELAYED IN-STENT STENOSIS AND IN-STENT THROMBOSIS IN PATIENTS TREATED WITH SAC (STENT-ASSISTED COIL EMBOLIZATION). PATIENTS WERE TREATED WITH EITHER DUAL MICROCATHETER ASSISTED COIL EMBOLIZATION OF STENT-ASSISTED COIL EMBOLIZATION, 120 PATIENTS WERE INCLUDED IN THE SAC GROUP. THE SAC GROUP WAS MAINTAINED ON DUAL ANTIPLATELET THERAPY, PRE, DURING AND POST INTERVENTION. THE MEAN AGE OF THE PATIENTS WAS 57 + 1.5 YEARS. IN THE PATIENTS TREATED WITH SAC, SYMPTOMATIC DELAYED IN-STENT STENOSIS OCCURRED IN FIVE (5) PATIENTS AND IN-STENT THROMBOSIS OCCURRED IN FOUR (4) PATIENTS. TWO (2) PATIENTS TREATED WITH SAC HAD ANEURYSM GROWTH AFTER INTERVENTION AND WERE RETREATED WITH MICROSURGICAL CLIPPING AND THROMBUS RESECTION. NO PRODUCT INFORMATION WAS REPORTED AND THE DEVICES REMAIN IMPLANTED THUS UNAVAILABLE FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318654 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM CNV ENTERPRISE SES (NJE) NJE CODMAN AND SHURTLEFF, INC N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R