BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 6743549 · Received July 26, 2017

    Report

    Report Number
    1226348-2017-00127
    Event Type
    Death
    Date Received
    July 26, 2017
    Date of Event
    April 15, 2016
    Report Date
    July 3, 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

    MANUFACTURER¿S REF. NO: (B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS TO CORRECT THE EVENT TYPE TO ¿DEATH¿. IT WAS PREVIOUSLY ENTERED AS "SERIOUS INJURY".

    Additional Manufacturer Narrative · 1

    THIS IS INITIAL/FINAL MDR REPORT BEING SUBMITTED FOR THIS COMPLAINT WITH ASSOCIATED MFR# 1226348-2017-00127. 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 ON A MONTHLY BASIS FOR SAFETY SIGNALS AND WILL BE FOLLOWED BY MONTHLY TRENDING ASSESSMENTS AS WELL AS PMS REVIEWS. UDI UNAVAILABLE, LOT UNKNOWN; EXPIRATION DATE UNAVAILABLE, LOT UNKNOWN; MANUFACTURING DATE UNAVAILABLE; LOT UNKNOWN. THERE ARE NO ALLEGED QUALITY ISSUES WITH THE PRODUCT. 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 THERE IS NO EVIDENCE OF A MANUFACTURING-RELATED MALFUNCTION, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. NO DEVICE RETURNED. THROMBOEMBOLISM, HEMORRHAGE AND NEUROLOGICAL DEFICITS IS LISTED IN THE CODMAN ENTERPRISE PRODUCT IFU AS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE USE OF THE PRODUCT. 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 MEDICATION REGIMEN AND UNDERLYING DISEASE STATE MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. MAY HAVE CONTRIBUTED TO THE EVENT. NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IN THE LITERATURE ARTICLE "LVIS STENT VERSUS ENTERPRISE STENT FOR THE TREATMENT OF UNRUPTURED INTRACRANIAL ANEURYSMS" BY HUIJIAN GE, XIANLI LV, XINJIAN YANG, HONGWEI HE, HENGWEI JIN, YOUXIANG LI, PUBLISHED WORLD NEUROSURG. (2016) 91:365-370. HTTP://DX.DOI.ORG/10.1016/J.WNEU.2016.04.057, 1 HEMORRHAGE, 1 MASS EFFECT, AND 14 THROMBOEMBOLIC EVENTS WERE REPORTED IN PATIENTS WHO WERE TREATED FOR UNRUPTURED ANEURYSMS USING STENT-ASSISTED COILING. PER THE ARTICLE; "FROM NOVEMBER 2014 TO DECEMBER 2015, TOTAL 190 PATIENTS WITH 208 UNRUPTURED INTRACRANIAL ANEURYSMS WERE COILED ASSISTED BY LVIS AND ENTERPRISE STENTS. 92 PATIENTS WITH 96 ANEURYSMS RECEIVED LVIS STENTS AND 98 PATIENTS WITH 112 ANEURYSMS WERE TREATED WITH ENTERPRISE STENTS. PROCEDURE-RELATED COMPLICATIONS, CLINICAL OUTCOMES, AND ANGIOGRAPHIC RESULTS WERE ANALYZED RETROSPECTIVELY. PROCEDURE RELATED COMPLICATIONS OCCURRED IN 16 PATIENTS (16.3%, 16/98) IN THE ENTERPRISE GROUP. THERE WERE NO SIGNIFICANT DIFFERENCES IN RATE OF COMPLICATIONS BETWEEN THE LVIS AND THE ENTERPRISE GROUP. THROMBOEMBOLIC COMPLICATIONS OCCURRED IN 14 PATIENTS (14.3%, 14/98) IN THE ENTERPRISE GROUP. REGARDING HEMORRHAGIC COMPLICATIONS, INTRAOPERATIVE RUPTURE OCCURRED IN 1 PATIENT IN THE ENTERPRISE GROUP. ONE PATIENT SUFFERED MASS EFFECT, WHICH WAS CAUSED BY GIANT ANEURYSM AFTER THE DEPLOYMENT OF ENTERPRISE STENT. THESE COMPLICATIONS CAUSED PERMANENT NEUROLOGIC DEFICITS (MORBIDITY) IN 3.1% PATIENTS (3/98) IN THE ENTERPRISE GROUP (MRS SCORE OF 3 AT DISCHARGE). IN TOTAL, 1 PATIENT IN ENTERPRISE GROUP DIED OF A SEVERE DELAYED THROMBOEMBOLIC EVENT. THE PROCEDURE-RELATED MORTALITY RATE WAS 1.0% 1/98) IN THE ENTERPRISE GROUP. AT THE TIME OF COMPLAINT ENTRY, NO DEVICE SPECIFIC INFORMATION, I.E. CATALOGUE/LOT NUMBER, IS AVAILABLE.

    Description of Event or Problem · 1

    IN THE LITERATURE ARTICLE ¿LVIS STENT VERSUS ENTERPRISE STENT FOR THE TREATMENT OF UNRUPTURED INTRACRANIAL ANEURYSMS¿ BY HUIJIAN GE, XIANLI LV, XINJIAN YANG, HONGWEI HE, HENGWEI JIN, YOUXIANG LI, PUBLISHED WORLD NEUROSURG. (2016) 91:365-370. HTTP://DX.DOI.ORG/10.1016/J.WNEU.2016.04.057, 1 HEMORRHAGE, 1 MASS EFFECT, AND 14 THROMBOEMBOLIC EVENTS WERE REPORTED IN PATIENTS WHO WERE TREATED FOR UNRUPTURED ANEURYSMS USING STENT-ASSISTED COILING. PER THE ARTICLE; ¿FROM NOVEMBER 2014 TO DECEMBER 2015, TOTAL 190 PATIENTS WITH 208 UNRUPTURED INTRACRANIAL ANEURYSMS WERE COILED ASSISTED BY LVIS AND ENTERPRISE STENTS. 92 PATIENTS WITH 96 ANEURYSMS RECEIVED LVIS STENTS AND 98 PATIENTS WITH 112 ANEURYSMS WERE TREATED WITH ENTERPRISE STENTS. PROCEDURE-RELATED COMPLICATIONS, CLINICAL OUTCOMES, AND ANGIOGRAPHIC RESULTS WERE ANALYZED RETROSPECTIVELY. PROCEDURE RELATED COMPLICATIONS OCCURRED IN 16 PATIENTS (16.3%, 16/98) IN THE ENTERPRISE GROUP. THERE WERE NO SIGNIFICANT DIFFERENCES IN RATE OF COMPLICATIONS BETWEEN THE LVIS AND THE ENTERPRISE GROUP. THROMBOEMBOLIC COMPLICATIONS OCCURRED IN 14 PATIENTS (14.3%, 14/98) IN THE ENTERPRISE GROUP. REGARDING HEMORRHAGIC COMPLICATIONS, INTRAOPERATIVE RUPTURE OCCURRED IN 1 PATIENT IN THE ENTERPRISE GROUP. ONE PATIENT SUFFERED MASS EFFECT, WHICH WAS CAUSED BY GIANT ANEURYSM AFTER THE DEPLOYMENT OF ENTERPRISE STENT. THESE COMPLICATIONS CAUSED PERMANENT NEUROLOGIC DEFICITS (MORBIDITY) IN 3.1% PATIENTS (3/98) IN THE ENTERPRISE GROUP (MRS SCORE OF 3 AT DISCHARGE). IN TOTAL, 1 PATIENT IN ENTERPRISE GROUP DIED OF A SEVERE DELAYED THROMBOEMBOLIC EVENT. THE PROCEDURE-RELATED MORTALITY RATE WAS 1.0% 1/98) IN THE ENTERPRISE GROUP. AT THE TIME OF COMPLAINT ENTRY, NO DEVICE SPECIFIC INFORMATION, I.E. CATALOGUE/LOT NUMBER, IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524182 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM INTRACRANIAL NEUROVASCULAR STENT NJE CODMAN AND SHURTLEFF, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R