BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 4954458 · Received July 30, 2015

    Report

    Report Number
    1058196-2015-00156
    Event Type
    Death
    Date Received
    July 30, 2015
    Date of Event
    February 24, 2015
    Report Date
    August 3, 2015
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED AND THE STERILE LOT NUMBER WAS NOT REPORTED; THEREFORE, NO DHR COULD BE PERFORMED. CEREBRAL HEMORRHAGE IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE USE OF THE ENTERPRISE STENT 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. THIS WAS AN OFF-LABEL USE OF THE DEVICE IN AN EMERGENT SITUATION TO TREAT RECURRENT THROMBUS IN THE CEREBRAL VASCULATURE. REVIEW OF THE INFORMATION SUGGESTS THAT PATIENT AND TARGET VESSEL ISSUES, SPECIFICALLY THE HYPER DYNAMIC COAGULATION OF THE TARGET SITE, MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. UDI: UNKNOWN PART NUMBER, THE DEVICE WAS IMPLANTED AND NOT AVAILABLE, UDI UNAVAILABLE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED 8/3/2015: IT IS UNKNOWN WHETHER THE PATIENT HAD ANY ALLERGIES TO ANY METALS. THE ONLY KNOWN MEDICAL CONDITIONS KNOWN IN THE PATIENT¿S MEDICAL HISTORY INCLUDED HYPERTENSION AND OBESITY. CONCOMITANT DEVICES USED TO DEPLOY THE STENT WERE THE PROWLER PLUS MICROCATHETER (DETAILS UNKNOWN) AND THE SL10 GUIDEWIRE (DETAILS UNKNOWN. THE REPORTER DENIED ANY DEVICE MALFUNCTION OR ANY TRAUMA, DISSECTION, OR VESSEL DAMAGE RELATED TO USE OF THE DEVICE. NO NEW CLOT OCCURRED AFTER THE STENT WAS PLACED. INR AND PT VALUES WERE MONITORED AT THE TIME OF THE PROCEDURE AND THE TWO SUBSEQUENT DAYS UNTIL THE PATIENT EXPIRED AND APPEARED NORMAL. THE CONCLUSIONS FROM THE INITIAL REPORT REMAIN THE SAME.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PURPOSE OF THIS MDR SUBMISSION IS TO CORRECT THE EVENT TYPE TO ¿DEATH¿. IT WAS PREVIOUSLY ENTERED AS "SERIOUS INJURY".

    Description of Event or Problem · 1

    AN OFF LABEL/EMERGENT USE OF THE ENTERPRISE HDE STENT (DETAILS UNKNOWN) WAS PLACED IN THE PATIENT. TWO DAYS AFTER, THE PATIENT DEVELOPED LEFT FRONTAL LOBE INTRAPARENCHYMAL AND SUBARACHNOID HEMORRHAGE RESULTING IN DEATH. THE PATIENT PRESENTED FROM AN OUTSIDE HOSPITAL WITH SUDDEN ONSET RIGHT HEMIPLEGIA AND APHASIA. INITIAL NIHSS OF 13. ANGIOGRAPHY REVEALED OCCLUSION OF M1, M2 SEGMENTS OF THE LEFT MIDDLE CEREBRAL ARTERY (MCA.) THROMBECTOMY WAS PERFORMED WITH TICI 2B RESULTS. SEVERAL HOURS LATER THE PT.¿S NEURO EXAM DECLINED AND IMAGING REVEALED RECURRENT OCCLUSION OF THE M1 SEGMENT OF THE LEFT MCA. THROMBECTOMY WAS PERFORMED AGAIN A DAY AFTER INITIAL THROMBECTOMY. REOPRO WAS ADMINISTERED FOR REMAINING THROMBUS WITH REDUCTION IN THROMBUS. THE VESSEL WAS NOTED HOWEVER TO HAVE SOME REMAINING THROMBUS AND APPEARED TO BE IRREGULAR. THE SOLITAIRE WAS AGAIN DEPLOYED TO REMOVE REMAINING THROMBUS AND AN ENTERPRISE STENT WAS DEPLOYED TO COVER THE ENTIRE LEFT MCA M1 SEGMENT TO CORRECT THE IRREGULARITY AND PROTECT INTEGRITY OF THE VESSEL. RESULTS WERE GOOD RESULTING AGAIN IN A TICI 2B SCORE. THE PATIENT WAS PLACED ON HEPARIN AND BEGAN SLOWLY IMPROVING. APPROXIMATELY 10 HOURS POST OPERATION, THE PATIENT HAD SUDDEN AND PROFOUND NEURO DECLINE. CT DEMONSTRATED THE DEVELOPMENT OF LEFT FRONTAL LOBE INTRAPARENCHYMAL AND SUBARACHNOID HEMORRHAGE WITH CEREBRAL EDEMA, MASS EFFECT AND LEFT TO RIGHT MIDLINE SHIFT. COMFORT CARE MEASURES INITIATED TWO DAYS AFTER THE PATIENT WAS EXTUBATED AND THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496926 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM CNV ENTERPRISE SES (NJE) NJE CODMAN AND SHURTLEFF, INC N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Death