BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 6907138 · Received October 2, 2017

    Report

    Report Number
    1226348-2017-00163
    Event Type
    Injury
    Date Received
    October 2, 2017
    Date of Event
    July 20, 2014
    Report Date
    September 5, 2016
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KN
    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. ARTICLE ATTACHED TO THE MDR: CHO, Y.D., KANG, H.S., KIM, J.E. ET. AL. (2014). MODIFIED PROTECTION USING FAR PROXIMAL PORTION OF SELF-EXPANDABLE CLOSED-CELL STENTS FOR EMBOLIZATION OF WIDE-NECKED INTRACRANIAL ANEURYSMS, NEURORADIOLOGY (2014) 56:851¿857 DOI 10.1007/S00234-014-1402-7. DATE OF EVENT, PRODUCT CODE, AND LOT NUMBER COULD NOT BE OBTAINED FROM THE AUTHOR. THREE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL. IF ADDITIONAL INFORMATION IS OBTAINED AT A LATER DATE, THE FILE WILL BE UPDATED AT THAT TIME. UDI: UNKNOWN PART NUMBER, ATTEMPTS TO OBTAIN PRODUCT PART NUMBER WERE UNSUCCESSFUL, UDI UNAVAILABLE. CONCLUSION: THE DEVICES WERE NOT AVAILABLE FOR ANALYSIS. IN ADDITION, NO LOT NUMBERS COULD BE OBTAINED; THEREFORE, A DHR COULD NOT BE PERFORMED FOR THE DEVICES. STROKE, ISCHEMIA AND NEUROLOGICAL DEFICIT ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE ENTERPRISE STENT AND CEREBRAL STENTING PROCEDURES. THE ROOT CAUSE OF THE STROKE CANNOT BE DETERMINED; HOWEVER, PRE-EXISTING ANEURYSM HISTORY AND PHARMACOLOGICAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. THERE IS NO CURRENT SAFETY SIGNAL IDENTIFIED RELATED TO THE REPORTED EVENT BASED ON REVIEW OF COMPLAINT HISTORY FOR THE DEVICE. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS IS AN INITIAL/FINAL MDR REPORT. THIS IS 1 OF 2 MDRS BEING SUBMITTED FOR THIS LITERATURE ARTICLE WITH REPORT NUMBERS OF 1226348-2017-00163 AND 1226348-2017-00164.

    Description of Event or Problem · 1

    IN THE LITERATURE ARTICLE ¿MODIFIED PROTECTION USING FAR PROXIMAL PORTION OF SELF-EXPANDABLE CLOSED-CELL STENTS FOR EMBOLIZATION OF WIDE-NECKED INTRACRANIAL ANEURYSMS¿ BY CHO, Y.D., KANG, H.S., KIM, J.E. ET. AL., PUBLISHED NEURORADIOLOGY (2014) 56:851¿857 DOI 10.1007/S00234-014-1402-7, IT WAS REPORTED THAT PATIENT NUMBER 2, A (B)(6)-YEAR-OLD FEMALE WHO PRESENTED WITH A MIDDLE CEREBRAL ARTERY BIFURCATION ANEURYSM APPROXIMATELY 6MM IN SIZE HAD A DELAYED CEREBRAL INFARCTION APPROXIMATELY 2-MONTHS POST ENTERPRISE IMPLANTATION. IT WAS REPORTED THAT THERE WAS COMPLETE ANEURYSM OCCLUSION AT 6 MONTHS. PER THE ARTICLE, STENT-ASSISTED EMBOLIZATION IS SOMETIMES LIMITED IN WIDE-NECKED ANEURYSMS INVOLVING THE ACUTE-ANGLED ORIGINS OF TORTUOUS BRANCHING ARTERIES, AND OCCASIONALLY, Y-SHAPED STENTING IS REQUIRED TO REMEDY THE SWEEPING EFFECTS OF A BROAD ANEURYSMAL NECK ON ARTERIAL BRANCHES. THE ARTICLE DESCRIBED A MODIFIED STENT-ASSISTED COIL EMBOLIZATION TECHNIQUE ENTAILING STRATEGIC PLACEMENT OF FAR PROXIMAL STENT (¿DISTAL STENTING¿) AS AN ALTERNATE APPROACH IN SUCH SCENARIOS. BETWEEN JANUARY 2009 AND FEBRUARY 2014 12 ANEURYSM (8 FEMALES AND 4 MALES) WERE SUBJECTED TO THE DISTAL STENTING METHOD. ALL ANEURYSMS WERE UNRUPTURED WIDE-NECKED LESIONS. ALL PATIENTS WERE GIVEN 75 MG OF CLOPIDOGREL AND 100 MG OF ASPIRIN FOR A MINIMUM OF 5 DAYS BEFORE THE PROCEDURE, OR THEY RECEIVED LOADING DOSES OF CLOPIDOGREL AND ASPIRIN (300 MG EACH) 1 DAY PRIOR TO THE PROCEDURE AND WERE SUPPLEMENTED (CLOPIDOGREL, 75 MG; ASPIRIN, 100 MG) ON THE MORNING OF THE PROCEDURE. IN PATIENTS SHOWING POOR RESPONSE TO CLOPIDOGREL, CILOSTAZOL WAS ADDED. A BOLUS OF HEPARIN (3,000 IU) WAS ADMINISTERED AFTER FEMORAL ARTERIAL SHEATH PLACEMENT AND THEREAFTER AT HOURLY INTERVALS (1,000 IU/H) OR AS NEEDED TO MAINTAIN ACTIVATED CLOTTING TIME AT 250 TO 300 S. DUAL ANTIPLATELET MEDICATION WAS ALSO RECOMMENDED TO BE MAINTAINED FOR AT LEAST 1 MONTH AFTER THE PROCEDURE, AND A SINGLE AGENT WAS TO BE MAINTAINED FOR AT LEAST 1 YEAR. NO DEVICE, PROCEDURE OR PATIENT SPECIFIC INFORMATION WAS PROVIDED IN THE ARTICLE, INCLUDING CATALOG AND LOT NUMBERS. NO ADDITIONAL INFORMATION, INCLUDED DEVICE CATALOG AND LOT NUMBERS OR DATE OF PROCEDURE OR EVENT COULD BE OBTAINED FROM THE AUTHOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686919 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM INTRACRANIAL NEUROVASCULAR STENT NJE CODMAN AND SHURTLEFF, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Life Threatening