BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 4596505 · Received March 12, 2015

    Report

    Report Number
    1058196-2015-00059
    Event Type
    Injury
    Date Received
    March 12, 2015
    Date of Event
    September 4, 2014
    Report Date
    February 19, 2015
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED IN THIS LITERATURE ARTICLE ¿THROMBOEMBOLIC EVENTS ASSOCIATED WITH SINGLE BALLOON-, DOUBLE BALLOON-, AND STENT ASSISTED COIL EMBOLIZATION OF ASYMPTOMATIC UNRUPTURED CEREBRAL ANEURYSMS: EVALUATION WITH DIFFUSION-WEIGHTED IMAGING¿ BY TAKIGAWA, T; SUZUKI, K, SUGIURA, Y; SUZUKI, R; TAKANO, I; SHIMIZU, N; TANAKA, Y; HYODO, A IN NEURORADIOLOGY, INTERVENTIONAL RADIOLOGY, (2014) 56:1079-1086. MULTIPLE EVENTS OF THROMBOEMBOLISM WERE NOTED ON IMAGING AFTER INTERVENTION WAS PERFORMED USING ENTERPRISE AND NON-CODMAN STENT ASSISTED COIL EMBOLIZATION. THE PURPOSE OF THIS STUDY WAS TO DETERMINE THE FREQUENCY OF THROMBOEMBOLIC EVENTS ASSOCIATED WITH SINGLE BALLOON-ASSISTED, DOUBLE BALLOON-ASSISTED, AND STENT-ASSISTED COIL EMBOLIZATION FOR ASYMPTOMATIC UNRUPTURED ANEURYSMS. DWI (DIFFUSION-WEIGHTED IMAGING) SHOWED HYPERINTENSE LESIONS IN 48 (40 %) PATIENTS, AND TEN (21 %) OF THESE PATIENTS INCURRED NEUROLOGICAL DETERIORATION (PERMANENT, TWO; TRANSIENT, EIGHT). ALL ENDOVASCULAR TREATMENTS WERE PERFORMED BY ONE OPERATOR (A.H.). PATIENTS WERE PRETREATED WITH CLOPIDOGREL 75 MG/DAYBEFORE SINGLE BALLOON-ASSISTED COIL EMBOLIZATION, AND WITH DUAL ANTIPLATELET AGENTS (CLOPIDOGREL 75 MG/DAY AND ASPIRIN 100 MG/DAY) BEFORE DOUBLE BALLOON- AND STENT-ASSISTED COIL EMBOLIZATION FOR A MINIMUM OF 4 DAYS. CLOPIDOGREL AND/OR ASPIRIN WERE GIVEN WITHOUT ANY INHIBITION TEST MADE PRIOR TO TREATMENT. INTERVENTIONAL PROCEDURES WERE CONDUCTED UNDER GENERAL ANESTHESIA. EMBOLIZATION WAS PERFORMED UNDER SYSTEMIC HEPARINIZATION TO MAINTAIN ACTIVATED CLOTTING TIME AT 2¿ 2.5 TIMES THE BASELINE THROUGH THE PROCEDURE. ALL FLUSHED SALINE AND CONTRAST MEDIUM WERE HEPARINIZED (1,000 IU/ 100 ML), AND A GUIDING CATHETER AND MICROCATHETER WERE PLACED WITH A CONTINUOUS HEPARINIZED DRIP. THE COMPLAINT PRODUCT WAS NOT AVAILABLE FOR ANALYSIS. NO STERILE LOT NUMBER WAS REPORTED THUS NO DHR COULD BE CONDUCTED. THROMBOSIS AND THROMBOTIC EMBOLIZATION ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH INTRACRANIAL STENTING AS CONJUNCTIVE THERAPY FOR COIL EMBOLIZATION PROCEDURES. ALL PRODUCTS ARE 100% INSPECTED PRIOR TO LEAVING THE MANUFACTURING FACILITY AND THERE IS NO EVIDENCE OF A MANUFACTURING RELATED ISSUE. THE ENTERPRISE IFU LISTS CONCOMITANT ANTI-THROMBOTIC MEDICAL THERAPY RECOMMENDED WHICH HAS BECOME COMMON MEDICAL TREATMENT IN CONJUNCTION WITH INTERVENTIONAL TRANSCATHETER PROCEDURES. REVIEW OF THE INFORMATION SUGGESTS THAT TARGET, VESSEL AND PATIENT FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. THIS IS AN INITIAL/FINAL REPORT. UDI: UNKNOWN PART NUMBER, PRODUCT REMAINS IMPLANTED AND WAS NOT RETURNED FOR ANALYSIS, UDI IS UNAVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED ¿THROMBOEMBOLIC EVENTS ASSOCIATED WITH SINGLE BALLOON-, DOUBLE BALLOON-, AND STENT ASSISTED COIL EMBOLIZATION OF ASYMPTOMATIC UNRUPTURED CEREBRAL ANEURYSMS: EVALUATION WITH DIFFUSION-WEIGHTED IMAGING¿ BY TAKIGAWA, T; SUZUKI, K, SUGIURA, Y; SUZUKI, R; TAKANO, I; SHIMIZU, N; TANAKA, Y; HYODO, A IN NEURORADIOLOGY, INTERVENTIONAL RADIOLOGY, (2014) 56:1079-1086. MULTIPLE EVENTS OF THROMBOEMBOLISM WERE NOTED ON IMAGING AFTER INTERVENTION WAS PERFORMED USING ENTERPRISE AND NON-CODMAN STENT ASSISTED COIL EMBOLIZATION. THE PURPOSE OF THIS STUDY WAS TO DETERMINE THE FREQUENCY OF THROMBOEMBOLIC EVENTS ASSOCIATED WITH SINGLE BALLOON-ASSISTED, DOUBLE BALLOON-ASSISTED, AND STENT-ASSISTED COIL EMBOLIZATION FOR ASYMPTOMATIC UNRUPTURED ANEURYSMS. DWI (DIFFUSION-WEIGHTED IMAGING) SHOWED HYPERINTENSE LESIONS IN 48 (40 %) PATIENTS, AND TEN (21 %) OF THESE PATIENTS INCURRED NEUROLOGICAL DETERIORATION (PERMANENT, TWO; TRANSIENT, EIGHT). ALL ENDOVASCULAR TREATMENTS WERE PERFORMED BY ONE OPERATOR (A.H.). PATIENTS WERE PRETREATED WITH CLOPIDOGREL 75 MG/DAYBEFORE SINGLE BALLOON-ASSISTED COIL EMBOLIZATION, AND WITH DUAL ANTIPLATELET AGENTS (CLOPIDOGREL 75 MG/DAY AND ASPIRIN 100 MG/DAY) BEFORE DOUBLE BALLOON- AND STENT-ASSISTED COIL EMBOLIZATION FOR A MINIMUM OF 4 DAYS. CLOPIDOGREL AND/OR ASPIRIN WERE GIVEN WITHOUT ANY INHIBITION TEST MADE PRIOR TO TREATMENT. INTERVENTIONAL PROCEDURES WERE CONDUCTED UNDER GENERAL ANESTHESIA. EMBOLIZATION WAS PERFORMED UNDER SYSTEMIC HEPARINIZATION TO MAINTAIN ACTIVATED CLOTTING TIME AT 2¿ 2.5 TIMES THE BASELINE THROUGH THE PROCEDURE. ALL FLUSHED SALINE AND CONTRAST MEDIUM WERE HEPARINIZED (1,000 IU/ 100 ML), AND A GUIDING CATHETER AND MICROCATHETER WERE PLACED WITH A CONTINUOUS HEPARINIZED DRIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170390 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM CNV ENTERPRISE SES (NJE) NJE CODMAN AND SHURTLEFF, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other