BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 6883803 · Received September 21, 2017

    Report

    Report Number
    1226348-2017-00155
    Event Type
    Injury
    Date Received
    September 21, 2017
    Date of Event
    September 15, 2014
    Report Date
    August 27, 2017
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INITIAL/FINAL MDR WILL BE THE ONLY REPORT SUBMITTED FOR MFR REPORT #1226348-2017-00155. UDI: UNKNOWN PART NUMBER, SEVERAL ATTEMPTS TO OBTAIN PRODUCT WERE UNSUCCESSFUL, UDI UNAVAILABLE. CONCLUSION: BASED ON THE INFORMATION, THE EVENT COULD NOT BE CONFIRMED. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS AND A DEVICE HISTORY RECORD REVIEW CANNOT BE COMPLETED BECAUSE THE LOT FOR THE PRODUCT IS UNKNOWN. SINCE THE EVENT COULD NOT BE CONFIRMED AND THERE IS NO EVIDENCE OF A MANUFACTURING-RELATED MALFUNCTION, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THROMBOSIS IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE USE OF THE CODMAN ENTERPRISE DEVICE AND IS LISTED IN THE IFU AS SUCH. ALTHOUGH THERE IS NOT PRODUCT SPECIFIC INFORMATION AVAILABLE, 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 DOES NOT SUGGEST WHAT FACTORS MAY HAVE CONTRIBUTED TO THIS EVENT; HOWEVER, MEDICATION REGIMEN AND INTRAPROCEDURAL ISSUES ARE KNOWN TO CONTRIBUTE TO THESE TYPES OF EVENTS. THERE IS NO CURRENT SAFETY SIGNAL IDENTIFIED RELATED TO THE REPORTED EVENT BASED ON REVIEW OF COMPLAINT HISTORY FOR THE DEVICE. NO FURTHER ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IN THE LITERATURE ARTICLE ¿THE STENT-ASSISTED COIL-JAILING TECHNIQUE FACILITATES EFFICIENT EMBOLIZATION OF TINY CEREBRAL ANEURYSMS¿ BY CONG-HUI LI, MD, PHD, XIAN-HUI SU, MD, BO ZHANG, MD, YONG-FENG HAN, MD, ER-WEI ZHANG, MD, LEI YANG, MD, DONG-LIANG ZHANG, MD, SONG-TAO YANG, MD, ZHEN-QUAN YAN, MD, BU-LANG GAO, MD, PHD, PUBLISHED KOREAN J RADIOL 2014;15(6):850-857, HTTP://DX.DOI.ORG/10.3348/KJR.2014.15.6.850, PISSN 1229-6929 · EISSN 2005-8330, IT WAS REPORTED THAT PATIENT # 1, AND (B)(6) MALE WHO PRESENTED WITH A RUPTURED OPHTHALMIC ANEURYSM SIZED 1.7 X 1.9MM, TREATED WITH A SINGLE UNKNOWN ENTERPRISE STENT AND A SINGLE UNKNOWN COIL HAD AN INTRAPROCEDURAL THROMBOSIS. PER THE ARTICLE: ¿TINY CEREBRAL ANEURYSMS ARE DIFFICULT TO EMBOLIZE BECAUSE THE ANEURYSM¿S SAC IS TOO SMALL FOR A SINGLE SMALL COIL, AND COILS WITHIN THE ANEURYSM MAY ESCAPE FROM THE CONFINEMENT OF A STENT. THIS STUDY WAS PERFORMED TO INTRODUCE THE STENT-ASSISTED COIL-JAILING TECHNIQUE AND TO INVESTIGATE ITS EFFECT ON THE COIL EMBOLIZATION OF TINY INTRACRANIAL ANEURYSMS.¿ IT WAS REPORTED THAT APPROPRIATE TREATMENT WAS GIVEN AND NO FURTHER EVENTS WERE REPORTED FOR THIS PATIENT. AT THE TIME OF COMPLAINT ENTRY, NO DEVICE SPECIFIC INFORMATION, I.E. CATALOGUE/LOT NUMBER, IS AVAILABLE. THIS SUBMISSION IS RELATED TO A LITERATURE ARTICLE DISCOVERED IN AN EFFORT TO SUPPORT THE CER SUBMISSION PROCESS, AS SUCH, THE ASSOCIATED TIME FRAME OF EVENT DATES INCLUDES BUT IS NOT LIMITED TO 20 YEARS. THESE ARTICLES ARE BEING REVIEWED MONTHLY FOR SAFETY SIGNALS AND WILL BE FOLLOWED BY MONTHLY TRENDING ASSESSMENTS AS WELL AS PMS REVIEWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662927 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM INTRACRANIAL NEUROVASCULAR STENT NJE CODMAN AND SHURTLEFF, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention