BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 5754668 · Received June 28, 2016

    Report

    Report Number
    1226348-2016-00112
    Event Type
    Injury
    Date Received
    June 28, 2016
    Date of Event
    June 8, 2016
    Report Date
    June 9, 2016
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF TWO FINAL REPORT BEING SUBMITTED FOR THIS COMPLAINT WITH ASSOCIATED MFR REPORT# 3008264254-2016-00042. CONCOMITANT PRODUCTS: CONCOMITANT DEVICES: TERUMO GLIDEWIRE GUIDE WIRE; PENUMBRA BENCHMARK GUIDING CATHETER; STRYKER SYNCHRO GUIDEWIRE; STRYKER SL-10 45 DEGREE ANGLED MICROCATHETER; STRYKER TARGET NANO COILS (3);PENUMBRA SMART EXTRASOFT COIL (1). (B)(4) REVIEWED THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF THE ABOVE MENTIONED LOT 10665774. THE DEVICE HISTORY RECORD REVIEW ALSO INCLUDED A REVIEW OF THE CERTIFICATE OF CONFORMANCE RECEIVED FROM SPECIALTY COATINGS SYSTEMS AND NITINOL DEVICES AND COMPONENTS, ALONG WITH (B)(4) INTERNAL RECEIVING INSPECTION RECORDS FOR THE STENTS ISSUED TO THE COMPLAINT LOT. THE HISTORY RECORDS INDICATE THIS PRODUCT WAS FINAL INSPECTION TESTED AT (B)(4) AND WAS DETERMINED TO BE ACCEPTABLE. VASOSPASM AND HEADACHE, REPRESENTATIVE OF NEUROLOGIC SYMPTOMS, ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE USE OF THE ENTERPRISE DEVICE AND ARE LISTED IN THE IFU AS SUCH. ALL PRODUCTS UNDERGO A 100% INSPECTION PRIOR TO BEING RELEASED FOR SALE; THERE IS NO EVIDENCE OF A MANUFACTURING ISSUE RELATED TO THIS COMPLAINT. VASOSPASM CAN BE INDUCED IN THE MUSCULAR ARTERIAL WALLS BY THE INTRODUCTION OF INVASIVE AND INTERVENTIONAL DEVICES. REVIEW OF THE AVAILABLE INFORMATION SUGGESTS THAT TARGET LESION, INTRODUCTION OF INTERVENTIONAL DEVICES AND UNDERLYING DISEASE PROCESS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THERE IS NO NEED FOR FURTHER ACTION AT THIS TIME. COMMON DEVICE NAME CHANGED FROM "CNV ENTERPRISE SES (NJE)" TO "INTRACRANIAL NEUROVASCULAR STENT."

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF ONE INITIAL/FINAL MDR REPORT BEING SUBMITTED FOR THIS COMPLAINT. (B)(4) LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF THE ABOVE MENTIONED LOT. THE DEVICE HISTORY RECORD REVIEW ALSO INCLUDED A REVIEW OF THE CERTIFICATE OF CONFORMANCE RECEIVED FROM SPECIALTY COATINGS SYSTEMS AND NITINOL DEVICES AND COMPONENTS, 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 IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE USE OF THE ENTERPRISE DEVICE AND IS LISTED IN THE IFU AS SUCH. ALL PRODUCTS UNDERGO A 100% INSPECTION PRIOR TO BEING RELEASED FOR SALE; THERE IS NO EVIDENCE OF A MANUFACTURING ISSUE RELATED TO THIS COMPLAINT. VASOSPASM CAN BE INDUCED IN THE MUSCULAR ARTERIAL WALLS BY THE INTRODUCTION OF INVASIVE AND INTERVENTIONAL DEVICES. REVIEW OF THE AVAILABLE INFORMATION SUGGESTS THAT TARGET LESION, INTRODUCTION OF INTERVENTIONAL DEVICES AND UNDERLYING DISEASE PROCESS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THERE IS NO NEED FOR FURTHER ACTION AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SITE ON (B)(6) 2016 THAT THE PATIENT EXPERIENCED MINIMAL HEADACHES WITH A ONSET DATE OF (B)(6) 2016. THIS ADVERSE EVENT WAS REPORTED TO BE ANTICIPATED, NEW AND NON-SERIOUS WHICH RESOLVED WITH NO RESIDUAL EFFECTS ON (B)(6) 2016. PATIENT DATA ALSO REVEALED THAT IMMEDIATE POST-PROCEDURE ANGIOGRAPHIC IMAGING REPORTED COIL MASS WAS MAINTAINED WITHIN SAC AND THE PARENT ARTERY WAS PATENT. THERE WAS NO EVIDENCE OF PARENT VESSEL STENOSIS OR THROMBOSIS. THERE WAS COMPLETE STENT COVERAGE ACROSS THE ANEURYSM AND THERE NO REDUCTION OF FLOW OF THE PARENT ARTERY. PROWLER SELECT PLUS MICROCATHETER (606S255FX/17458595) WAS ALSO USED DURING THE PROCEDURE. FOUR COMPETITORS COILS WERE IMPLANTED IN THE ANEURYSM. DURING THE 30 DAY FOLLOW-UP ON (B)(6) 2016 THERE WERE NO NEW ADVERSE EVENTS OR WORSENING OF PREVIOUS EVENTS. THERE WERE NO REPORTS OF PRODUCT MALFUNCTION.

    Description of Event or Problem · 1

    AS REPORTED BY THE (B)(6) STUDY, PATIENT (B)(6) EXPERIENCED RECENT ONSET OF HEADACHES ON (B)(6) 2016. BASELINE NIHSS SCORE AND MRS REPORTED TO BE ZERO. PATIENT HAD SIDE EFFECTS TO KEPPRA( ANGER) AND WAS REPORTED TO HAVE HEMATOMA AT ANGIOGRAM ACCESS SITE. PATIENT ENROLLED IN THE STUDY ON (B)(6) 2016. PRETREATMENT ANGIOGRAM PERFORMED ON (B)(6) 2016 REVEALED AN ANTERIOR CIRCULATION, SIDE WALL, SACCULAR ANEURYSM LOCATED ON THE CAROTID OPHTHALMIC ARTERY AND OF MAXIMUM DOME HEIGHT 4.2MM, DOME WIDTH 4.2MM. ON (B)(6) 2016, PATIENT EXPERIENCED INTRAOPERATIVE VASOSPASM RESPONSIVE TO VERAPAMIL. EVENT WAS REPORTED TO BE MILD, NON-SERIOUS AND RESOLVED WITH NO RESIDUAL EFFECTS ON (B)(6) 2016. PATIENT IMPLANTED WITH ENTERPRISE 2 4MM X 30MM STENT (ENF403012/10665774), IT IS UNKNOWN WHETHER THE VASOSPASM OCCURRED PRIOR TO OR AFTER THE STENT BEING IMPLANTING. EVENT WAS NOT RELATED TO CODMAN DEVICE, ANY OTHER DEVICES USED, UNDERLYING DISEASE STATE) AND DEFINITELY RELATED TO PROCEDURE. NO REPORT OF THROMBOSIS, REDUCED TICI FLOW OR OTHER INTRA-OPERATIVE COMPLICATIONS RECEIVED. PATIENT'S ANEURYSM WAS TREATED TO 70-89% OCCLUSION, RAYMOND CLASS 3. PRODUCT IS NOT AVAILABLE FOR ANALYSIS. STENT REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409890 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM INTRACRANIAL NEUROVASCULAR STENT NJE CODMAN AND SHURTLEFF, INC 10665774

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention