BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 6685440 · Received July 4, 2017

    Report

    Report Number
    1226348-2017-00089
    Event Type
    Injury
    Date Received
    July 4, 2017
    Date of Event
    April 6, 2011
    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
    PA, 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. UDI UNAVAILABLE; LOT UNKNOWN. EXPIRATION DATE UNKNOWN, LOT UNKNOWN. CONCOMITANT MEDICAL PRODUCTS: GUIDING CATHETER (SHUTTLE, COOK INC, (B)(4), USA), 2.3 F PROWLER SELECT PLUS MICROCATHETER (CORDIS CO, (B)(4),USA), 0.014 INCH, 300 CM ACCELERATOR WIRE (EV3, (B)(4), USA). MANUFACTURING DATE UNKNOWN, LOT UNKNOWN. THERE ARE NO ALLEGED QUALITY ISSUES WITH THE PRODUCT. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS AND A DEVICE HISTORY RECORD REVIEW CANNOT BE COMPLETED BECAUSE THE LOT FOR THE PRODUCT IS UNKNOWN. SINCE THERE IS NO EVIDENCE OF A MANUFACTURING-RELATED MALFUNCTION, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. NO DEVICE RETURNED THROMBOEMBOLISM IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE CODMAN ENTERPRISE SES DEVICE AND IS LISTED IN THE IFU. ALTHOUGH THERE IS NOT PRODUCT SPECIFIC INFORMATION AVAILABLE, 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 THAT TARGET SITE/ PARENT VESSEL ANATOMY AND MEDICATION REGIMEN MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. NO FURTHER ACTIONS ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IN THE LITERATURE ARTICLE ¿Y STENTING USING KISSING STENTS FOR THE TREATMENT OF BIFURCATION ANEURYSMS¿ BY BRIAN T JANKOWITZ, AJITH THOMAS, TUDOR JOVIN, MICHAEL HOROWITZ, PUBLISHED J NEUROINTERVENT SURG 2012;4:16E21. DOI:10.1136/JNIS.2010.004275, IT WAS REPORTED THAT PATIENT #1 HAD DELAYED THROMBOEMBOLISM AFTER UNKNOWN ENTERPRISE STENT IMPLANTATION, WHILE ON DUAL ANTI-PLATELET MEDICAL THERAPY. PER THE ARTICLE: ¿BACKGROUND AND PURPOSE COILING OF WIDE NECK, BIFURCATION ANEURYSMS OFTEN REQUIRE CREATIVE TECHNIQUES TO ENSURE OPTIMAL AND SAFE EMBOLIZATION. THE Y STENTING TECHNIQUE UTILIZING KISSING STENTS PROVIDES AN ALTERNATIVE ENDOVASCULAR TREATMENT OF THIS COMPLEX PATHOLOGY¿. Y STENTING UTILIZING THE TRIPLE CATHETER TECHNIQUE IS AN ALTERNATIVE ENDOVASCULAR TREATMENT FOR WIDE NECK, BIFURCATION ANEURYSMS. CAUTION SHOULD BE USED, ESPECIALLY IN THE SETTING OF SUBARACHNOID HEMORRHAGE, AS THE COMPLICATION RATE AND OVERALL RISK INCREASE SIGNIFICANTLY WITH THIS TECHNIQUE¿S COMPLEXITY.¿ PATIENT # 1 HAD A BASILAR APEX ANEURYSM OF DIAMETER 9MM AND NECK DIAMETER 5MM. TWO ENTERPRISE STENTS WERE IMPLANTED, OF SIZE 4.5 X 22. PATIENT RETURNED 36 DAYS AFTER TREATMENT WITH ACUTE ONSET VERTIGO, ATAXIA AND DYSARTHRIA FOLLOWED BY PROGRESSIVE NEUROLOGICAL DECLINE. EMERGENT CATHETER BASED ANGIOGRAPHY REVEALED A NEAR OCCLUSIVE THROMBUS IN THE BASILAR APEX WITH DELAYED TRANSIT TIMES INTO THE BILATERAL POSTERIOR CEREBRAL ARTERIES. EPTIFIBATIDE (15 MG INTRAVENOUSLY) WAS ADMINISTERED, FOLLOWED BY ANOTHER 15 MG OF INTRAARTERIAL EPTIFIBATIDE DIRECTLY INTO THE THROMBUS. POST-PROCEDURE ANGIOGRAPHIC RUNS SHOWED COMPLETE PATENCY OF THE BASILAR ARTERY WITH IMPROVED TRANSIT TIMES. THE PATIENT MADE A COMPLETE RECOVERY WITH NO PERSISTENT NEUROLOGICAL DEFICITS (MODIFIED RANKIN SCALE SCORE OF 0). THE TIME FRAME FOR THE THROMBOEMBOLISM WAS NOT SPECIFICALLY REPORTED. 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
    465812 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM INTRACRANIAL NEUROVASCULAR STENT NJE CODMAN AND SHURTLEFF, INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention