BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 4173739 · Received October 15, 2014

    Report

    Report Number
    1058196-2014-00263
    Event Type
    Injury
    Date Received
    October 15, 2014
    Date of Event
    September 16, 2014
    Report Date
    November 19, 2014
    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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LAKE REGION MEDICAL REVIEWED THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 10207862. 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. STROKE AND NEUROLOGICAL SYMPTOMS ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH CEREBRAL STENTING AND OTHER CEREBRAL PROCEDURES. BASED ON THE INFORMATION PROVIDED, AND AS REPORTED BY THE NEUROLOGIST, THE CVA WAS MOST LIKELY ASSOCIATED WITH THE INTENTIONAL ARTERIAL OCCLUSION OF THE CEREBELLAR ARTERY. THERE WAS NO INDICATION OF ANY ADVERSE EVENTS OR PRODUCT MALFUNCTIONS DURING THE PROCEDURE, AND THE STENT WAS NOTED TO BE FULLY EXPANDED AND APPOSED TO THE VESSEL WALL. SINCE THERE WAS NO EVIDENCE OF A MANUFACTURING ISSUE RELATED TO THE EVENT, NO CORRECTIVE ACTION WILL BE TAKEN.

    Additional Manufacturer Narrative · 1

    THERE WERE NO NEUROLOGICAL SYMPTOMS AT BASELINE. THE DISTAL SECTION OF THE PARENT ARTERY MEASURED 3.2 MM IN DIAMETER AND THE PROXIMAL SECTION MEASURED 3.4 MM IN DIAMETER. AFTER DEPLOYMENT THE STENT FULLY EXPANDED AND APPOSED THE VESSEL WALL. THE STENT WAS PATENT AFTER THE EVENT. NO COILS PROTRUDED FROM THE PARENT VESSEL. TWO DAYS LATER THE PATIENT¿S SPEECH MUTISM HAD IMPROVED, VISUAL SYMPTOMS (PTOSIS) IMPROVED, AND EXTRAOCULAR MUSCLE ISSUES IMPROVED. THERE WERE NO INTRAPROCEDURAL ADVERSE EVENTS OR PRODUCT MALFUNCTION. THE REPORTED CAUSE OF THE STROKE WAS THE ELECTIVE OCCLUSION OF THE LEFT SUPERIOR CEREBELLAR ARTERY. THIS WAS A PLANNED AND EXPECTED EVENT FROM WHICH A SIGNIFICANT CLINICAL IMPROVEMENT AND LIKELY RETURN TO NORMAL FUNCTION IS EXPECTED TO OCCUR OVER SEVERAL MONTHS. THE STROKE WAS MONITORED WITH SUPPORTIVE CARE AND TIGHT MANAGEMENT OF RISK FACTORS IN THE HOSPITAL. (B)(4). CONCOMITANT PRODUCTS: ANECTINE, FENTANYL, HEPARIN, HYDRALAZINE, LABETALOL, LACTATED RINGER¿S INJECTION, METOPROLOL, NITROGLYCERIN, NORMAL SALINE, PHENYLEPHRINE, PROPOFOL, SEVOFLURANE, VERSED, ZEMURON, ZOFRAN. CONCOMITANT DEVICES: TARGET 360 STANDARD COIL 5MM X 15CM (DETAILS UNKNOWN); TARGET 360 ULTRA COIL 3MM X 8CM (DETAILS UNKNOWN); TARGET 360 ULTRA COIL 3MM X 8CM (DETAILS UNKNOWN); TARGET 360 ULTRA COIL 2.5 X 4CM (DETAILS UNKNOWN); TARGET HELICAL ULTRA COIL 2MM X 4CM (DETAILS UNKNOWN); TWO EXCELSIOR SL-10 MICROCATHETERS (DETAILS UNKNOWN); PROWLER SELECT PLUS MICROCATHETER (606S255X/15886424); SYNCHRO -14 MICROWIRE (DETAILS UNKNOWN); PENUMBRA NEURON 6F 053 DELIVERY GUIDING CATHETER (DETAILS UNKNOWN); TRANSEND EX SOFT TIP MICROWIRE (DETAILS UNKNOWN). THIS IS REPORT 1 OF 2 RELATED TO COMPLAINT (B)(4). THE DEVICE HISTORY RECORD HAS NOT YET BEEN REVIEWED AND THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS. NO CONCLUSIONS ARE MADE AT THIS TIME.

    Description of Event or Problem · 1

    THE PATIENT EXPERIENCED A STROKE AFTER ENTERPRISE VRD (ENF451412/10207862) STENT-ASSISTED COILING OF THE COMPLEX SUPERIOR CEREBELLAR ARTERY (SCA) ANEURYSM AND OCCLUSION OF THE SCA ON THE LEFT. THE SCA ON THE LEFT AROSE FROM THE BASE OF THE ANEURYSM AND WAS PURPOSEFULLY OCCLUDED WITH TARGET COILS (DETAILS UNKNOWN). IT IS NOTED THAT THE SCA WOULD HAVE BEEN OCCLUDED HAD THE ANEURYSM BEEN SURGICALLY CLIPPED. THE ANEURYSM REQUIRED TREATMENT DUE TO THE PRESENCE OF A SIGNIFICANT DAUGHTER EXCRESCENCE ON THE ANTERIOR/SUPERIOR ASPECT OF THE PRIMARY ANEURYSM. THE LESION MEASURES APPROXIMATELY 6MM X 4.8MM WITH A NEARLY 4 MM NECK. THE DAUGHTER EXCRESCENCE AROSE EXTENDED SEVERAL MILLIMETERS OUT FROM THE ANEURYSM UP TOWARD THE POSTERIOR CEREBRAL ARTERY. THE COILS USED IN THE PROCEDURE WERE TARGET 360 STANDARD COIL 5MM X 15CM, TARGET 360 ULTRA COIL 3MM X 8CM, TARGET 360 ULTRA COIL 3MM X 8CM (NOT DETACHED), TARGET 360 ULTRA COIL 2.5 X 4CM, AND TARGET HELICAL ULTRA COIL 2MM X 4CM (NOT DETACHED). OTHER CONCOMITANT DEVICES INCLUDE TWO EXCELSIOR SL-10 MICROCATHETERS, A PROWLER SELECT PLUS MICROCATHETER (606S255X/15886424) A SYNCHRO -14 MICROWIRE, A PENUMBRA NEURON 6F 053 DELIVERY GUIDING CATHETER, AND A TRANSEND EX SOFT TIP MICROWIRE (ALL CATALOG AND LOT NUMBERS OF THE PRODUCTS OTHER THAN THE PROWLER SELECT PLUS ARE UNKNOWN). THE STENT WAS DELIVERED THROUGH THE PROWLER SELECT PLUS MICROCATHETER. THERE WAS NO DIFFICULTY TRACKING ANY OF THE MICROCATHETERS. THERE WAS NO DISSECTION OF ANY VESSEL WALL DURING THE PROCEDURE. AFTER THE PROCEDURE THERE WAS NO GROSS EVIDENCE OF FLOW WITHIN THE ANEURYSM. THERE WERE NO NEUROLOGICAL SYMPTOMS AT BASELINE. THE REPORTED PROCEDURE WAS COMPLETED AT 2:30 PM ON THE EVENT DATE. THE FIRST INDICATION OF A STROKE WAS AT 4 PM WHEN THE PATIENT EXPERIENCED SUBTLE RIGHT UPPER EXTREMITY PROXIMAL WEAKNESS AND DOUBLE VISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    655947 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM CNV ENTERPRISE SES (NJE) NJE CODMAN AND SHURTLEFF, INC ENF451412 10207862

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L