BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 6124424 · Received November 23, 2016

    Report

    Report Number
    1226348-2016-00174
    Event Type
    Injury
    Date Received
    November 23, 2016
    Date of Event
    July 1, 2016
    Report Date
    November 3, 2016
    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 IS FOUR OF FOUR INITIAL/FINAL MDR REPORT BEING SUBMITTED WITH ASSOCIATED MFR# 1226348-2016-00171, 1226348-2016-00172, 1226348-2016-00173 AND 1226348-2016-00174. CATALOG# AND LOT# UNKNOWN, THROMBOSIS, EMBOLISM AND RUPTURE OF THE TARGET ANEURYSM ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE USE OF THE ENTERPRISE VRD DEVICE AND ARE LISTED IN THE IFU. 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 VERY LIMITED INFORMATION SUGGESTS THAT PATIENT, TARGET LESION, INTRAPROCEDURAL AND MEDICATION ISSUES MAY HAVE ALL CONTRIBUTED TO THE UNSPECIFIED COMPLICATIONS. NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME. THE PRODUCT WAS NOT AVAILABLE FOR ANALYSIS. A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE CONDUCTED AS THE LOT NUMBER WAS NOT PROVIDED/KNOWN.

    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. WORLD NEUROSURG. (2016) 91:365-37. DATE OF PUBLICATION: 01 JUL 2016 CLINICAL AND ANGIOGRAPHIC OUTCOMES BETWEEN LVIS AND ENTERPRISE STENT WERE COMPARED. FROM NOVEMBER 2014 TO DECEMBER 2015, TOTAL 190 PATIENTS WITH 208 UNRUPTURED INTRACRANIAL ANEURYSMS WERE COILED ASSISTED BY LVIS AND ENTERPRISE STENTS (96 IN THE LVIS STENT GROUP AND 112 IN THE ENTERPRISE STENT GROUP). NONE OF THESE CASES HAD A HISTORY OF SUBARACHNOID HEMORRHAGE. THE PATIENT POPULATION TREATED WITH THE ENTERPRISE STENT CONSISTED OF 60 FEMALES AND THE MEAN AGE THE GROUP WAS 54 YEARS. OF THE 112 ANEURYSM TREATED WITH THE ENTERPRISE STENT 91 WERE OF ANTERIOR CIRCULATION AND 21 WERE POSTERIOR CIRCULATION WITH A MEAN ANEURYSM DIAMETER OF 7.52 +/- 4.43 MM. ON IMMEDIATE POSTOPERATIVE ANGIOGRAMS, THE OCCLUSION RATES IN THE ENTERPRISE GROUP WERE AS FOLLOWS; CLASS I WAS OBSERVED IN 84 ANEURYSMS, CLASS II IN 15 ANEURYSMS, AND CLASS III IN 13 ANEURYSMS. IN TOTAL, INITIAL COMPLETE AND NEAR-COMPLETE OBLITERATION WERE ACHIEVED IN 88.4% (99 OF 112) IN THE ENTERPRISE GROUP. PROCEDURE-RELATED COMPLICATIONS OCCURRED IN 10 PATIENTS (10/92) IN THE LVIS GROUP AND 16 PATIENTS (16/98) IN THE ENTERPRISE GROUP. THERE WERE NO SIGNIFICANT DIFFERENCES IN RATE OF COMPLICATIONS BETWEEN 2 GROUPS. THROMBOEMBOLIC COMPLICATIONS OCCURRED IN 14 PATIENTS 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 1.1% (1/92) LVIS VERSUS 1.0% (1/98 ENTERPRISE. CLINICAL FOLLOW-UP WAS AVAILABLE FOR 79/92 OF PATIENTS IN THE LVIS GROUP VERSUS 88/98 OF PATIENTS IN THE ENTERPRISE GROUP. A TOTAL OF 57.1% (56/98) IN THE ENTERPRISE GROUP RECEIVED AN ANGIOGRAPHIC FOLLOW-UP; 8 OF 56 (14.3%) PATIENTS WHO EMBOLIZED NEAR-COMPLETELY AND INCOMPLETELY IN THE ENTERPRISE STENTS GROUP SHOWED PROGRESSIVE THROMBOSIS OCCLUSION DURING THE FOLLOW-UP PERIOD. THE RECURRENCE RATE WAS 10.7% (6/56) FOR ENTERPRISE STENTS. ACCORDING TO FINAL FOLLOW-UP RESULTS, 80 PATIENTS (90.9%, 80/88) HAD FAVORABLE CLINICAL OUTCOMES IN THE ENTERPRISE GROUP. THIS REPORT FOR POST-OPERATIVE PROGRESSIVE THROMBOSIS IN 8 PATIENTS. 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
    775850 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM INTRACRANIAL NEUROVASCULAR STENT NJE CODMAN AND SHURTLEFF, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention