BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 2465326 · Received February 23, 2012

    Report

    Report Number
    1058196-2012-00096
    Event Type
    Injury
    Date Received
    February 23, 2012
    Date of Event
    September 28, 2010
    Report Date
    February 15, 2012
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WILL NOT BE RETURNED FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    PER LAKE REGION REPORT (B)(4) LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01422617. 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. 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.

    Additional Manufacturer Narrative · 1

    THE REPORT FROM (B)(4) CLINICAL STUDY INDICATED THAT DURING A STENT ASSISTED COIL EMBOLIZATION OF AN UNRUPTURED LEFT PARASELLAR ANEURYSM THE PATIENT DEVELOPED CEREBROVASCULAR SPASM. IT IS NOT KNOWN WHICH DEVICES WERE IN THE VASCULATURE WHEN THE EVENT OCCURRED. THE PATIENT WAS TREATED WITH THE ADMINISTRATION OF HEPARIN. THE EVENT OUTCOME AS OF TWO DAYS POST PROCEDURE WAS "RECOVERED WITHOUT SEQUELAE." THE ENTERPRISE WAS FULLY EXPANDED AND APPOSED TO THE VESSEL WALL AT ALL TIMES. ACCORDING TO THE PHYSICIAN, THE RELATIONSHIP OF THE EVENT TO THE PROCEDURE WAS HIGHLY PROBABLE AND TO THE VRD WAS UNKNOWN. THE PATIENT HAS A HISTORY OF CLIPPING OF THE ANTERIOR CEREBRAL ARTERY. THE UNRUPTURED SACCULAR PARASELLAR ANEURYSM NECK WAS 7.2MM, AND THE NECK TO SAC RATIO WAS 7.2MM: 7.2MM. THE PARENT VESSEL SIZE DIAMETER PROXIMAL WAS 5.2MM AND DISTALLY WAS 5.0MM. THE RECOMMENDED PARENT VESSEL UPPER LIMIT DIAMETER FOR PLACEMENT OF THE ENTERPRISE VRD AS OUTLINED IN THE IFU IS 4.0MM. A JAILED TECHNIQUE WAS USED FOR THE PROCEDURE WITH EITHER ECHELON 10 OR EXCELSIOR SL10 FOR COIL DELIVERY. THE MODIFIED RANKIN SCALE (MRS) SCORE WAS 0 PRE-PROCEDURE AND TWO DAYS POST PROCEDURE. ACT WAS NOT MEASURED. NO FURTHER INFORMATION REGARDING THE EVENT IS AVAILABLE AND PROCEDURAL IMAGES ARE NOT AVAILABLE. LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01422617. 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. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT LAKE REGION MEDICAL AND WAS DETERMINED TO BE ACCEPTABLE. VASOSPASM, OR CONTRACTION OF SMOOTH MUSCLE FIBERS IN THE WALL OF A VESSEL AS A RESULT OF DIRECT PHYSICAL IRRITATION OF THE ENDOTHELIUM, IS A COMMONLY RECOGNIZED ADVERSE EVENT ASSOCIATED WITH ENDOVASCULAR PROCEDURES AND IS OUTLINED AS A POTENTIAL ADVERSE EVENT IN THE INSTRUCTIONS FOR USE. BASED ON THE AVAILABLE INFORMATION, AND AS REPORTED, NO CONCLUSION CAN BE MADE REGARDING THE RELATIONSHIP OF THE EVENT TO THE DEVICE. THERE IS NO INDICATION OF ANY DEVICE DESIGN OR MANUFACTURING ISSUES; THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    THE REPORT FROM CLINICAL STUDY (B)(4) FOR PATIENT (B)(6) INDICATED THAT THE PROCEDURE WAS COIL EMBOLIZATION ASSISTED WITH AN ENTERPRISE VRD ((B)(4)/01422617) OF THE LEFT PARASELLAR, AND DURING THE PROCEDURE, THE PATIENT DEVELOPED CEREBROVASCULAR SPASM. THE PATIENT WAS TREATED WITH THE ADMINISTRATION OF HEPARIN. THE EVENT OUTCOME AS OF TWO POST PROCEDURE WAS RECOVERED WITHOUT SEQUELAE. ACCORDING TO THE PHYSICIAN, THE RELATIONSHIP OF THE EVENT TO THE PROCEDURE WAS HIGHLY PROBABLE AND TO THE VRD WAS UNKNOWN. A JAILED TECHNIQUE WAS USED FOR THE PROCEDURE WITH EITHER ECHELON 10 OR EXCELSIOR SL10, AND THE ENTERPRISE WAS FULLY EXPANDED AND APPOSE TO THE VESSEL WALL AT ALL TIMES. NO FURTHER INFORMATION WAS AVAILABLE. THE UNRUPTURED SACCULAR ANEURYSM NECK WAS 7.2MM, AND THE NECK TO SAC RATIO WAS 7.2MM: 7.2MM. THE PARENT VESSEL SIZE DIAMETER PROXIMAL WAS 5.2MM AND DISTALLY WAS 5.0MM. ANTIPLATELET THERAPY INCLUDED ASPIRIN 100MG/DAY: 2010-(B)(6), CLOPIDOGREL SULFATE 75MG/DAY: 2010-(B)(6) - 2011-(B)(6), CILOSTAZOL 200MG/DAY: 2010-(B)(6). HEPARIN 10000U: 2010-(B)(6), 8000U: 2010-(B)(6). HEPARIN 5000U WAS ADMINISTRATED INTRA-PROCEDURALLY. THE OCCLUSION RATE OF ANEURYSM WAS 0% AFTER THE PROCEDURE. PRIOR TO IMPLANTING THE VRD, ROADMASTER/GOODMAN, PROWLER SELECT PLUS ((B)(4)/LOT# UNKNOWN), RADIFOCUS GT/TERUMO, QUICK FLEX/KANEKA WERE UTILIZED. OTHER DEVICES UTILIZED DURING THE PROCEDURE WERE, EXCELSIOR SL10, ECHELON 10/COVIDIEN (B)(4), GDC/STRYKER/BS (B)(4)(NOT PLACED DUE TO THE SPASM). NO FURTHER INFORMATION IS AVAILABLE AND PROCEDURAL IMAGES ARE NOT AVAILABLE.

    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 01422617

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention