BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 2222462 · Received August 25, 2011

    Report

    Report Number
    1058196-2011-00426
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    June 16, 2011
    Report Date
    August 10, 2011
    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 REPORT FROM (B)(6) STUDY INDICATED THAT THE EMERGENT PROCEDURE WAS COIL EMBOLIZATION ASSISTED WITH AN ENTERPRISE VRD (B)(4) FOR A RUPTURED ANEURYSM OF THE (BA) BASILAR ARTERY "TIP, AND DUE TO THE RUPTURED ANEURYSM, THE PATIENT DEVELOPED STROKE IN THE DISTAL PORTION OF THE RIGHT POSTERIOR CEREBRAL ARTERY RESULTING IN A PARTIAL VISUAL FIELD DEFECT. ADDITIONALLY, THE AFTER THE STENT AND COILING PROCEDURE WAS COMPLETED, THE PHYSICIAN COMMENTED THAT IT IS POSSIBLE THAT THE EFFECT OF THE ANTI-PLATELET AGENT CAME TOO LATE, AND THIS MIGHT HAVE PRODUCED A THROMBUS/STROKE. NO ACTION WAS TAKEN. A MONTH AFTER THE PROCEDURE, THE STROKE WAS NOTED AS RESOLVED, AND THE VISUAL FIELD DEFECT WAS NOTED AS ONGOING BUT IMPROVED. THE RELATIONSHIP OF BOTH EVENTS TO THE ENTERPRISE WAS REPORTED AS UNRELATED. THE (B)(6) BEFORE THE PROCEDURE WAS 4 WITH NO INFORMATION AVAILABLE REGARDING SPECIFIC NEUROLOGICAL DEFICITS. 1 WEEK AFTER THE PROCEDURE WAS THE MRS WAS 4, AND 1 MONTH AFTER THE PROCEDURE WAS THE MRS WAS 4 = "MODERATELY SEVERE DISABILITY; UNABLE TO WALK WITHOUT ASSISTANCE AND UNABLE TO ATTEND TO OWN BODILY NEEDS WITHOUT ASSISTANCE". NO FURTHER INFORMATION IS AVAILABLE REGARDING THE PATIENT'S STATUS. THE SACCULAR RUPTURED ANEURYSM MEASURED 4.5MM AT THE NECK AND THE NECK TO SAC RATIO WAS 4.5MM/12.0MM, AND THE PARENT VESSEL DIAMETER PROXIMALLY AND DISTALLY WAS 3.0MM. THE ACT WAS NOT MEASURED. PRIOR OR DURING THE PROCEDURE, NO THROMBUS WAS NOTED AT THE SITE. THE ENTERPRISE WAS FULLY EXPANDED AND APPOSE TO THE VESSEL WALL AND IN A STABLE POSITION AFTER PLACEMENT. A TOTAL OF 9 COILS WERE PLACED. THE RESIDUAL FLOW INTO THE ANEURYSM WAS 90% AFTER THE PROCEDURE. NO COILS WERE PROTRUDING INTO THE PARENT ARTERY. THE PATENCY OF THE STENT AT THE TIME OF THE EVENT IS UNKNOWN. NO FURTHER INFORMATION OR PROCEDURAL/DIAGNOSTIC FILMS ARE AVAILABLE. THE ENTERPRISE VRD REMAINS IMPLANTED. LAKE REGION MEDICAL REVIEWED THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01428090. 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 ACCOMPANYING NEUROLOGICAL SYMPTOMS ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE USE OF THE ENTERPRISE VRD IN THE INTRACEREBRAL ARTERIES AS OUTLINED IN THE INSTRUCTIONS FOR USE (IFU). HOWEVER BASED ON THE AVAILABLE INFORMATION, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE RELATIONSHIP OF THE ENTERPRISE VRD AND THE STROKE AND RESULTING DEFICITS. BASED ON THE REPORT THAT THE PATIENT DEVELOPED A STROKE DUE TO THE PRE-EXISTING RUPTURED ANEURYSM AND THE BASELINE MRS SCORE, IT APPEARS THAT THESE FACTORS AND RESULTING CONTRAINDICATION OF PRE-PROCEDURE ANTIPLATELET THERAPY LIKELY CONTRIBUTED TO THE EVENTS. THERE HAVE BEEN STUDIES SHOWING EVIDENCE FOR A GENERALIZED STRONG ACTIVATION OF THE COAGULATION AND FIBRINOLYTIC SYSTEM IN PATIENTS WITH SUBARACHNOID HEMORRHAGE. BASED ON THE REPORTED INFORMATION, THERE IS NO INDICATION OF ANY DEVICE PERFORMANCE OR MANUFACTURING ISSUES RELATED TO THE REPORTED EVENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE ENTERPRISE WAS FULLY EXPANDED AND APPOSED TO THE VESSEL WALL AND IN A STABLE POSITION AFTER PLACEMENT. THE RESIDUAL FLOW INTO THE ANEURYSM WAS 90% AFTER THE PROCEDURE. NO COILS WERE PROTRUDING INTO THE PARENT ARTERY. THE ANTIPLATELET THERAPY CONSISTED OF ASPIRIN 100MG/DAY: (B)(6) 2011, CLOPIDOGREL SULFATE 75MG/DAY: (B)(6) 2011, AND HEPARIN UNKNOWN DOSAGE: (B)(6) 2011 (DURING THE PROCEDURE). THE SACCULAR RUPTURED ANEURYSM MEASURED 4.5MM AT THE NECK AND THE NECK TO SAC RATIO WAS 4.5MM/12.0MM, AND THE PARENT VESSEL DIAMETER PROXIMALLY AND DISTALLY WAS 3.0MM. THE PATIENT'S MEDICAL HISTORY CONSISTED OF 20 YEARS AGO THE PATIENT UNDERWENT A CRANIECTOMY BECAUSE OF A MENINGIOMA. A CD COPY OF THE PROCEDURE WAS NOT AVAILABLE, AND THE PRODUCT WILL NOT BE RETURNED FOR EVALUATION. NO FURTHER INFORMATION WAS PROVIDED OR AVAILABLE. PRODUCTS UTILIZED DURING THE CASE CONSISTED OF LAUNCHER GUIDING CATHETER (MEDTRONIC), PROWLER SELECT PLUS MICROCATHETER (606-S255X/LOT# UNKNOWN), CHIKAI GUIDEWIRE (ASAHI INTECC), RADIFOCUS GT X2 (TERUMO), EXCELSIOR SL-10 MICROCATHETER (BOSTON SCIENTIFIC), PRESIDIO COIL (MICRUS), DELTAPLUSH X7 (MICRUS), AND DELTAPAQ X2 (MICRUS). THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    THE REPORT FROM CLINICAL STUDY (B)(4) FOR PATIENT WITH ID#(B)(4) INDICATED THAT THE EMERGENT PROCEDURE WAS COIL EMBOLIZATION ASSISTED WITH AN ENTERPRISE VRD (ENC452212) FOR A RUPTURED ANEURYSM OF THE (BA) BASILAR ARTERY - TIP, AND DUE TO THE RUPTURED ANEURYSM, THE PATIENT DEVELOPED STROKE IN THE DISTAL PORTION OF THE RIGHT POSTERIOR CEREBRAL ARTERY, RESULTING IN A PARTIAL VISUAL FIELD DEFECT. ADDITIONALLY, THE AFTER THE STENT AND COILING PROCEDURE WAS COMPLETED, ACCORDING TO THE PHYSICIAN, THE EFFECT OF THE ANTI-PLATELET AGENT CAME TOO LATE, AND THIS MIGHT HAVE PRODUCED A THROMBUS/STROKE. NO ACTION WAS TAKEN. A MONTH AFTER THE PROCEDURE, THE STROKE WAS NOTED AS RESOLVED, AND THE VISUAL FIELD DEFECT WAS NOTED AS ONGOING BUT IMPROVED. PHYSICIAN'S COMMENTED THAT "IT MIGHT BE POSSIBLE THAT THE EFFECT OF THE ANTI-PLATELET AGENT CAME TOO LATE, AND THIS MIGHT HAVE CAUSED STROKE." THE RELATIONSHIP OF BOTH EVENTS TO THE ENTERPRISE WAS UNRELATED. THE PATIENT WAS NOT ADMITTED WITH NEUROLOGICAL DEFICITS. PRIOR OR DURING THE PROCEDURE, NO THROMBUS WAS NOTED AT THE SITE. AFTER THE STENT AND COILING PROCEDURE WAS COMPLETED, THE EFFECT OF THE ANTI-PLATELET AGENT CAME TOO LATE, AND THIS MIGHT HAVE PRODUCED A THROMBUS/STROKE.

    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 01428090

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Life Threatening