BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 1920509 · Received December 13, 2010

    Report

    Report Number
    1058196-2010-00372
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    September 30, 2010
    Report Date
    November 26, 2010
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    NJE
    PMA / PMN Number
    HDE H60001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER FURTHER REVIEW THE REPORTED EVENT DOES NOT MEET THE CRITERIA FOR SERIOUS INJURY. THEREFORE, PLEASE NOTE THAT NO FURTHER INFORMATION WILL BE FORTHCOMING REGARDING THE EVENT.

    Additional Manufacturer Narrative · 1

    ANGIOGRAMS WERE TAKEN AFTER THE EVENT THAT SHOWED THE STENT STABLE AND THE ANEURYSM WAS 90% OCCLUDED. A CD COPY OF ALL PROCEDURES WAS NOT AVAILABLE. THE STENT WAS PATENT AFTER THE PROCEDURE WAS COMPLETED. MEDICATIONS GIVEN PRE-PROCEDURE CONSISTED OF ASPIRIN 100MG/DAY, CLOPIDOGREL SULFATE 75MG/DAY, CILOSTAZOL 200MG/DAY, ARGATROBAN HYDRATE 40MG/DAY, AND HEPARIN 7000U/DAY. A TOTAL OF 9 NON-CORDIS/CODMAN COILS WERE IMPLANTED (MICROPLEX, CASHMERE COMPLEX, DELTA PAQ). THE ACT PRE ANTICOAGULANT THERAPY WAS 129SECS AND POST-ANTICOAGULANT THERAPY WAS 246SECS. THE PATIENT HAD NO MEDICAL HISTORY (NO INFORMATION ABOUT THE ALLERGY). THE ANEURYSM MAXIMUM DIAMETER WAS 11.6MM, NECK 10.1MM, NECK TO SAC RATIO WAS 10.1MM/10.9MM, AND FUSIFORM. THE VESSEL DIAMETER PROXIMAL WAS 3.3 AND DISTALLY WAS 4.3MM. NO FURTHER INFORMATION WAS AVAILABLE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    LR PACKAGING L/N # 01419843, 13471872. PER LAKE REGION REPORT (B)(4): LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01419843. THE DEVICE HISTORY RECORD REVIEW ALSO INCLUDED A REVIEW OF THE CERTIFICATE OF CONFORMANCE RECEIVED FROM (B)(4), ALONG WITH LAKE REGION MEDICAL'S INTERNAL RECEIVING INSPECTION RECORDS FOR THE STENTS ISSUED TO THE COMPLAINT LOT. THIS PACKAGING LOT CONTAINED 23 UNITS, WHICH WERE SHIPPED FROM LAKE REGION MEDICAL ON FEBRUARY 26, 2010. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THIS (B)(4) STUDY INDICATED THAT THE PROCEDURE WAS COIL EMBOLIZATION ASSISTED WITH THE VRD STENT (ENC453712) FOR THE UNRUPTURED ANEURYSM IN VERTEBRAL ARTERY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY DIFFICULTY. HOWEVER, AFTER THE PROCEDURE, THE PATIENT HAD A MILD DEGREE OF HEADACHE, AND RECOVERED BY USING UNKNOWN PAIN MEDICATION. THE PHYSICIAN STATED THAT IT WAS UNKNOWN IF THIS EVENT HAD A CAUSAL RELATION WITH THE ENTERPRISE. THE 2ND ADVERSE EVENT CONSISTED OF THE PATIENT DEVELOPING WHEAL REACTION (1CM IN DIAMETER) OCCURRED ON THE TRUNK AFTER THE PROCEDURE, AND RECOVERED ON THE SAME DAY WITHOUT ANY TREATMENT. THE PHYSICIAN STATED THAT IT WAS ALLERGIC REACTION CAUSED BY CONTRAST MEDIA. THE 3RD EVENT WAS SWELLING OF THE PUNCTURE SITE 6 HOURS AFTER THE PROCEDURE, AND SHEATH REMOVAL. THE PHYSICIAN STATED THAT THIS EVENT WAS CAUSED BY DIFFICULTY OF HEMOSTASIS. THE BLEEDING OF THE PUNCTURE SITE WAS STOPPED BY APPLYING PRESSURE. THE PATIENT'S RECOVERY WAS CONFIRMED ON SIX DAYS LATER. CURRENTLY THE PATIENT IS IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM CNV ENTERPRISE SES (NJE) NJE CORDIS NEUROVASCULAR, INC. NA 13471872

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention COILS