BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 6692665 · Received July 7, 2017

    Report

    Report Number
    1226348-2017-00102
    Event Type
    Injury
    Date Received
    July 7, 2017
    Date of Event
    January 1, 2013
    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
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ARTICLE ATTACHED TO THIS MDR REPORT: MIYACHI, S. MATSUBARA, N., IZUMI, T., ET AL. (2013). STENT/BALLOON COMBINATION ASSIST TECHNIQUE FOR WIDE-NECKED BASILAR TERMINAL ANEURYSMS. INTERVENTIONAL NEURORADIOLOGY 19: 299-305, 2013. 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. DATE OF EVENT, PRODUCT CODE, AND LOT NUMBER COULD NOT BE OBTAINED FROM THE AUTHOR. 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. THROMBUS IN THE STENT IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH ENTERPRISE STENT AND STENTING PROCEDURES. THE ROOT CAUSE OF THE THROMBUS COULD NOT BE DETERMINED; HOWEVER, PATIENT AND PHARMACOLOGICAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. THERE IS NO CURRENT SAFETY SIGNAL IDENTIFIED RELATED TO THE REPORTED EVENTS BASED ON REVIEW OF COMPLAINT HISTORIES FOR THE DEVICE. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENTS WERE RELATED TO A MANUFACTURING ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    IN THE LITERATURE ARTICLE "STENT/BALLOON COMBINATION ASSIST TECHNIQUE FOR WIDE-NECKED BASILAR TERMINAL ANEURYSMS" BY SHIGERU MIYACHI, NORIAKI MATSUBARA, TAKASHI IZUMI, TAKUMI ASAI, TAKASHI YAMANOUCHI, KEISUKE OTA, KEIKO ODA, TOSHIHIKO WAKABAYASHI, PUBLISHED INTERVENTIONAL NEURORADIOLOGY 19: 299-305, 2013, IN-STENT THROMBOSIS WAS REPORTED IN PATIENT DURING STENT ASSISTED COIL EMBOLIZATION PROCEDURE USING AN ENTERPRISE STENT (CATALOG ENC452812 OR ENC452200, LOT UNKNOWN). A (B)(6) PATIENT (CASE 2) WHO PRESENTED WITH A BROAD-NECKED UNRUPTURED BASILAR TERMINAL ANEURYSM OF SIZE 9.6 MM, NECK 9.2 MM AND DOME/NECK RATIO 1.04. WAS TREATED WITH A COMBINED BALLOON/STENT ASSIST TECHNIQUE USING AN ENTERPRISE STENT (CATALOG/LOT UNKNOWN). A MICROCATHETER TO DELIVER THE STENT AND A MICROBALLOON CATHETER FOR NECK REMODELING WERE COAXIALLY INSERTED INTO THE GUIDING CATHETER. A PROWLER SELECT PLUS MICROCATHETER (CATALOG/LOT UNK) FOR STENT DELIVERY WAS ADVANCED IN ONE POSTERIOR CEREBRAL ARTERY (PCA) AND THE BALLOON CATHETER WAS PLACED IN THE OPPOSITE PCA . THE BALLOON WAS PLACED AT THE ORIGIN OF THE PCA ATTACHED TO THE STENT BODY. THE STENT WAS DEPLOYED ALONG THE LEFT PCA TO THE BASILAR ARTERY, AND THE BALLOON CATHETER WAS PLACED ON THE RIGHT PCA . DURING EMBOLIZATION, OPACIFICATION WORSENED BECAUSE OF STENT-INDUCED THROMBUS IN THE LEFT PCA AND THROMBUS AT THE ORIGIN OF THE RIGHT PCA. FORCED LOCAL FIBRINOLYSIS WITH AN ANTITHROMBOTIC AGENT RESULTED IN SUCCESSFUL RECANALIZATION. THE PATIENT WAS FULLY INTACT WITHOUT NEUROLOGICAL DEFICITS IN ALL COURSES, AND POST-OPERATIVE MRI SHOWED NO LARGE INFARCTED LESIONS EXCEPT FOR A FEW HIGH INTENSITY SPOTS IN THE IPSILATERAL OCCIPITAL AREA. POSTOPERATIVELY, THIS PATIENT WAS REGARDED AS A POOR RESPONDER TO CLOPIDOGREL BASED ON A PLATELET AGGREGATION TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473439 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM INTRACRANIAL NEUROVASCULAR STENT NJE CODMAN AND SHURTLEFF, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention PROWLER SELECT PLUS MICROCATHETER