BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 4966114 · Received August 4, 2015

    Report

    Report Number
    1058196-2015-00157
    Event Type
    Injury
    Date Received
    August 4, 2015
    Date of Event
    March 12, 2015
    Report Date
    July 15, 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 Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE STENTS REMAIN IMPLANTED THUS UNAVAILABLE FOR ANALYSIS AND NO STERILE LOT NUMBER INFORMATION HAS BEEN AVAILABLE SO NO DHR COULD BE PERFORMED. NEUROLOGIC DEFICITS, CEREBRAL INFARCTIONS AND TIAS ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE USE OF THE ENTERPRISE DEVICE AND ARE LISTED IN THE IFU AS SUCH. 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 TARGET SITE, LESION CHARACTERISTICS, PATIENT AND MEDICATION FACTORS MAY HAVE ALL CONTRIBUTED TO THE REPORTED EVENTS. THIS REPORT IS RELATED TO REPORT #'S 1058196-2015-00158 AND 1058196-2015-00159.

    Description of Event or Problem · 1

    IT WAS REPORTED IN LITERATURE ARTICLE ¿THE SAFETY AND EFFICACY OF TRIPLE ANTIPLATELET THERAPY AFTER INTRACRANIAL STENT-ASSISTED COIL EMBOLIZATION¿ BY YOSHIHISA MATSUMOTO, MD, PHD, MINORU IKO, MD, PHD, MASANORI TSUTSUMI, MD, PHD, TAKAHUMI MITSUTAKE, MD, AYUMU ETO, MD, KOUHEI NII, MD, PHD, KANJI NAKAI, MD, PHD, HIROMICHI OISHI, MD, HIROSHI AIKAWA, MD, PHD, AND KIYOSHI KAZEKAWA, MD, PHD, PUBLISHED IN JOURNAL OF STROKE AND CEREBROVASCULAR DISEASES, VOL. 24, NO. 7 (JULY), 2015: PP 1513-1519, THAT THERE WAS ONE EVENT OF HEMIPARESIS, 2 CEREBRAL INFARCTIONS AND 5 TIA¿S ASSOCIATED WITH ENTERPRISE VRD STENT IMPLANTATION. STENT-ASSISTED COIL EMBOLIZATION FOR INTRACRANIAL ANEURYSMS INCREASES PACKING DENSITY AND DECREASES THE COIL DEVIATION RATES OF THE PARENT ARTERY, AND IT IS ESPECIALLY USEFUL FOR WIDE-NECKED ANEURYSMS. HOWEVER, THIS PROCEDURE IS ASSOCIATED WITH THROMBOEMBOLIC EVENTS. THE OPTIMAL ANTIPLATELET AGENT REGIMEN FOR PATIENTS WHO HAVE UNDERGONE INTRACRANIAL STENT-ASSISTED COIL EMBOLIZATION HAS NOT YET BEEN ESTABLISHED. BETWEEN JULY 2010 AND MAY 2014, RETROSPECTIVE DATA WAS COLLECTED ON PATIENTS WITH UNRUPTURED INTRACRANIAL ANEURYSMS OR DURING THE CHRONIC PHASE OF RUPTURED INTRACRANIAL ANEURYSMS. THE ENTERPRISE VRD WAS USED IN 53 CASES. POSTOPERATIVE ISCHEMIC EVENTS PRIMARILY CONSISTED OF CEREBRAL INFARCTION, TRANSIENT ISCHEMIC ATTACK (TIA), OR EYE SYMPTOMS. THERE WAS 1 CASE OF HEMIPARESIS ON THE SIDE OPPOSITE OF THE STENTED VESSEL FOUND IMMEDIATELY AFTER THE OPERATION. SEVENTY EIGHT PATIENTS (19 MEN AND 59 WOMEN) WITH 79 CASES WERE INCLUDED IN POST-OPERATIVE MONITORING. CLINICAL OUTCOMES 140 DAYS POSTOPERATIVELY SHOWED THAT 7 OF THE 79 CASES IN THE DUAL GROUP EXPERIENCED POSTOPERATIVE ISCHEMIC EVENTS EVIDENCED BY DYSARTHRIA AND/OR MOTOR WEAKNESS AND/OR SENSORY DISTURBANCE ON THE SIDE OPPOSITE OF THE STENTED VESSEL, WHICH INDICATED THE LEGION OF THE STENTED VESSEL. CEREBRAL INFARCTION WAS DIAGNOSED IN 2 PATIENTS. THEIR SYMPTOMS WERE MILD, AND THEY WERE DISCHARGED WITHOUT ASSISTANCE. TIA WAS DIAGNOSED IN 5 PATIENTS AT 1, 3, 9, 12, AND 40 DAYS POSTOPERATIVELY. NONE OF THESE 7 CASES DISPLAYED EVIDENCE OF IN-STENT STENOSIS OF OVER 30% ON ANGIOGRAPHIC FOLLOW-UP, AND CARDIOGENIC EMBOLIC RISK FACTORS, INCLUDING ARTERIAL FIBRILLATION, WERE NOT PRESENT. POSTOPERATIVE ISCHEMIC EVENTS DID NOT OCCUR IN THE TRIPLE GROUP. THERE WAS NO SPECIFIC PRODUCT OR PROCEDURAL ISSUE NOTED. THE PRODUCT DID NOT PRESENT ANY VISUAL ANOMALY AND THERE WERE NO FUNCTIONAL ISSUES ASSOCIATED WITH THE PRODUCTS DURING THE REFERENCED PROCEDURES THAT CAUSED POSTOPERATIVE COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506083 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM CNV ENTERPRISE SES (NJE) NJE CODMAN AND SHURTLEFF, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening