BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 6674259 · Received June 28, 2017

    Report

    Report Number
    1226348-2017-00083
    Event Type
    Injury
    Date Received
    June 28, 2017
    Date of Event
    July 18, 2012
    Report Date
    June 11, 2017
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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. EVENTS THAT CAPTURED SPECIFIC PATIENT DEVICE OR PROCEDURE INFORMATION ARE LISTED IN INDIVIDUAL COMPLAINTS. THIS MDR IS TO CAPTURE 1 EVENTS OF INTRACRANIAL HEMORRHAGE. ARTICLE ATTACHED TO THIS MDR: KADKHADOYAN, Y., ET AL. (2012) RHODES, N., BLACKBURN, S. COMPARISON OF ENTERPRISE WITH NEUROFORM STENT-ASSISTED COILING OF INTRACRANIAL ANEURYSMS. AJR 2013; 200:872¿878. DATE OF EVENT, PRODUCT CODE, AND LOT NUMBER COULD NOT BE OBTAINED FROM THE AUTHOR. UDI: UNKNOWN PART NUMBER, ATTEMPTS TO OBTAIN PRODUCT PART NUMBER WERE UNSUCCESSFUL, UDI UNAVAILABLE. THIS IS AN INITIAL/FINAL MDR REPORT. CONCLUSION: THE PRODUCTS WERE NOT AVAILABLE FOR ANALYSIS. IN ADDITION, THE LOT NUMBERS WERE NOT AVAILABLE; THEREFORE, A DHR COULD NOT BE PERFORMED. STROKE IS A POTENTIAL EVENT THAT CAN OCCUR WITH THE ENTERPRISE STENT AND CEREBRAL STENTING PROCEDURES AND IS LISTED IN THE INSTRUCTIONS FOR USE (IFU). THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED; HOWEVER, PROCEDURAL FACTORS, VESSEL CHARACTERISTICS, CONCOMITANT DEVICES, PHARMACOLOGICAL FACTORS AND PATIENT CONDITION MAY HAVE CONTRIBUTED TO THIS EVENT. SINCE THERE WAS NO EVIDENCE OF MANUFACTURING ISSUES RELATED TO THE EVENT, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS IS 1 OF 3 MDR REPORTS BEING SUBMITTED FOR THIS COMPLAINT, WITH ASSOCIATED REPORT NUMBERS OF 1226348-2017-00081 AND 1226348-2017-00082.

    Description of Event or Problem · 1

    IN THE LITERATURE ARTICLE ¿COMPARISON OF ENTERPRISE WITH NEUROFORM STENT-ASSISTED COILING OF INTRACRANIAL ANEURYSMS¿ BY YASHA KADKHODAYAN, NICHOLAS RHODES, SPIROS BLACKBURN, COLIN P. DERDEYN, DEWITTE T. CROSS, III, CHRISTOPHER J. MORAN, PUBLISHED AJR 2013; 200:872¿878, IT WAS REPORTED THAT THERE WERE ADVERSE EVENTS AND TECHNICAL COMPLICATIONS ASSOCIATED WITH THE USE OF UNKNOWN ENTERPRISE STENTS. TECHNICAL COMPLICATIONS INCLUDED 7 UNABLE TO DEPLOY, 2 DIFFICULT TO DEPLOY (ONE GUIDE CATHETER CHANGE AND ONE RECAPTURE BEFORE DEPLOYMENT), 1 STENT MOVED (REQUIRING SECOND STENT PLACEMENT) AND 4 STENT MISPLACED REQUIRING SECOND STENT PLACEMENT. THERE WERE 12 PERIPROCEDURAL (30-DAY) SYMPTOMATIC NEUROLOGIC EVENTS, BOTH THROMBOEMBOLIC AND HEMORRHAGIC INCLUDING SEVEN TRANSIENT ISCHEMIC ATTACKS (3 CAPTURED IN SEPARATE COMPLAINTS), THREE ISCHEMIC STROKES (CAPTURED IN SEPARATE COMPLAINTS), THREE THROMBOEMBOLIC EVENTS (ALL CAPTURED IN SEPARATE COMPLAINTS), AND TWO INTRACRANIAL HEMORRHAGES (ONE CAPTURED IN A SEPARATE COMPLAINT). THE PROWLER SELECT PLUS MICROCATHETER (CATALOG/LOT NOT PROVIDED IN ARTICLE) COULD NOT BE POSITIONED ACROSS THE ANEURYSM NECK IN SEVEN CASES. THERE WERE 2 CASES OF INSTANT STENOSIS (OCCURRED IN THE SAME PATIENT AND CAPTURED IN SEPARATE COMPLAINT) ONE CASE OF DELAYED THROMBOSIS WITH PARENT ARTERY OCCLUSION (CAPTURED IN SEPARATE COMPLAINT). THE THROMBOEMBOLIC EVENTS OCCURRED IN VASCULAR TERRITORIES DISTAL TO THE TREATED VESSEL. IN THE CASES IN WHICH THE THROMBOEMBOLIC EVENT WAS IDENTIFIED INTRAOPERATIVELY (ANGIOGRAPHICALLY), ANTICOAGULATION WAS NOT REVERSED AS WOULD HAVE OTHERWISE BEEN DONE TO ENABLE HEMOSTASIS AT THE FEMORAL ARTERIOTOMY SITE. FIVE INTRAOPERATIVE INTRACRANIAL COMPLICATIONS WERE ASYMPTOMATIC. THERE WERE NO PROCEDURAL DEATHS. PER THE ARTICLE, ENTERPRISE STENT DEPLOYMENT SUCCESS WAS HIGH (108 OF 115 ATTEMPTS, 93.9%) WITH 102 ANEURYSMS RECEIVING A STENT. THE COILING MICROCATHETER WAS INSERTED INTO THE ANEURYSM BEFORE STENT DEPLOYMENT IN 70 OF 115 CASES (60.9%); NO STENT MOVEMENT GREATER THAN 1 MM WAS OBSERVED IN THESE CASES. THE JAILING TECHNIQUE, WHICH HAS BEEN USED SINCE THE BEGINNING OF OUR STENT-COILING EXPERIENCE, WAS PREFERENTIALLY USED FOR SMALLER ANEURYSMS, GENERALLY LESS THAN 3¿4 MM IN DIAMETER, CONSIDERED A HIGHER RISK TO CATHETERIZE THROUGH STENT INTERSTICES. TWO PROCEDURES WERE STAGED TO ALLOW ENDOTHELIALIZATION OF THE STENT IN THE SETTING OF PERCEIVED STENT INSTABILITY, AND THE PATIENTS RETURNED AFTER 8 WEEKS FOR COILING IN A DELAYED FASHION THROUGH THE STENT. THREE ENTERPRISE STENTS WERE PLACED TO TACK DOWN COIL TAILS; ONE WAS PLACED TO COVER A STRETCHED COIL. FIVE WERE DEPLOYED AFTER NEUROFORM PLACEMENT FAILED, AND FIVE WERE DEPLOYED THROUGH A PREVIOUSLY PLACED NEUROFORM THAT WOULD NOT RETAIN COILS. NO ADDITIONAL PATIENT, PROCEDURE OR DEVICE INFORMATION WAS PROVIDED FOR THE EVENTS CAPTURED IN THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455645 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM INTRACRANIAL NEUROVASCULAR STENT NJE CODMAN AND SHURTLEFF, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L