BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 2317261 · Received November 1, 2011

    Report

    Report Number
    1058196-2011-00482
    Event Type
    Injury
    Date Received
    November 1, 2011
    Date of Event
    January 27, 2011
    Report Date
    October 21, 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 INDEX PROCEDURE CONSISTED COIL EMBOLIZATION ASSISTED WITH THE ENTERPRISE VRD (ENC451412/01425618) OF AN ANEURYSM LOCATED IN BA-TOP. ACT MEASUREMENT WERE 125 SECONDS (PRE ANTICOAGULATION), AND 322 SECONDS (POST ANTICOAGULATION). THE OCCLUSION RATE OF ANEURYSMS WAS 100% AFTER THE PROCEDURE. MODIFIED RANKIN SCALE BEFORE THE PROCEDURE WAS 0, ONE WEEK AFTER THE PROCEDURE WAS 0, AND ONE MONTH AFTER THE PROCEDURE WAS 5. DEVICES UTILIZED DURING THE PROCEDURE CONSISTED OF LAUNCHER (GC) GUIDE CATHETER (MEDTRONIC), PROWLER SELECT PLUS (MC) MICROCATHETER (606-S255X/LOT UNKNOWN), X-PEDION (GW) GUIDEWIRE (COVIDIEN), EXCELSIOR SL10 MC (BOSTON SCIENTIFIC), TRAXCESS GW (TERUMO), CASHMERE COILS X6 (MICRUS), V-TRACK HYDRO-COIL 10 (TERUMO), DELTAPAQ COILS X4 (MICRUS), AND DELTAPLUSH COILS X 9 (MICRUS). THE STAGED PROCEDURE WAS CONDUCTED APPROXIMATELY TWO WEEKS AFTER THE INDEX PROCEDURE, AND CONSISTED OF COIL EMBOLIZATION ASSISTED WITH ENTERPRISE VRD (ENC453712/01423721). THE TARGET ANEURYSM WAS IN (RCS) RIGHT CAVERNOUS SINUS. ACT MEASUREMENTS WERE 118 SECONDS (PRE ANTICOAGULATION) AND 267 SECONDS (POST ANTICOAGULATION). THE OCCLUSION RATE OF ANEURYSMS WAS 100% AFTER THE PROCEDURE. MODIFIED RANKIN SCALE BEFORE THE PROCEDURE WAS 0, ONE WEEK AFTER THE PROCEDURE WAS 0. DEVICES UTILIZED DURING THE PROCEDURE CONSISTED OF LAUNCHER GC (MEDTRONIC), PROWLER SELECT PLUS MC (606-S255X/ LOT UNKNOWN), TRAXCESS GW, EXCELSIOR SL10 MC, TRAXCESS GW, V-TRACK MICROPLEX 18 COILS X4 (TERUMO), V-TRACK MICROPLEX 10 COILS X2, V-TRACK HYDROCOIL 10 X6, AND DELTAPLUSH X10. THE ANTIPLATELET THERAPY CONSISTED OF ASPIRIN 100MG/DAY: (B)(6) 2011, CLOPIDOGREL SULFATE 75MG/DAY: (B)(6) 2011, AND HEPARIN 4000U: (B)(6) 2011 (DURING THE PROCEDURE). THE SACCULAR ANEURYSMS WERE UNRUPTURED AND MEASUREMENTS CONSISTED OF BA-TOP NECK WAS 6.2MM AND RCS WAS 6.2MM, NECK TO SAC RATION WAS BA-TOP WAS 6.2MM X 10.5MM AND RCS WAS 6.2MM X 11.7MM. THE PARENT VESSEL SIZE/DIAMETERS FOR BA-TOP WERE PROXIMALLY 1.5 MM AND DISTALLY 1.5 MM, AND RCS PROXIMALLY WAS 3.8 MM AND DISTALLY 3.1 MM. NO CD COPY OF THE PROCEDURES AND EVENTS WERE AVAILABLE, AND NO FURTHER INFORMATION WAS AVAILABLE. THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFR REPORT 1058196-2011-00481 AND 1058196-2011-00482. THE PRODUCT WILL NOT BE RETURNED FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED VIA (B)(6) STUDY THAT THE PATIENT INITIALLY HAD AN ENTERPRISE VRD ASSISTED COIL EMBOLIZATION OF AN UNRUPTURED BASILAR TIP ANEURYSM FOLLOWED BY A STAGED ENTERPRISE VRD ASSISTED COILING OF AN UNRUPTURED RIGHT CAVERNOUS SINUS ANEURYSM 13 DAYS LATER. ONE DAY AFTER THE SECOND STAGED PROCEDURE, THE PATIENT HAD A MYOCARDIAL INFARCTION (MI) AND WAS TREATED WITH ISOSORBIDE DINITRATE. ADDITIONALLY THE PATIENT HAD DISTURBANCE OF CONSCIOUSNESS WHICH WAS REPORTED AS AN AFTER EFFECT OF THE MYOCARDIAL INFARCTION; HOWEVER, IT WAS INDICATED THAT (B)(6) SCORE ONE WEEK AFTER THE INDEX AND STAGED PROCEDURE WAS 0 AND ONE MONTH AFTER THE INDEX PROCEDURE, THE MRS SCORE WAS 5. THE EVENT OUTCOME AS OF FOUR MONTH POST EVENT IS "RECOVERED WITH SQUEAL (DISTURBANCE OF CONSCIOUSNESS)". THERE IS NO FURTHER INFORMATION REGARDING THE PATIENT'S SYMPTOMS; HOWEVER, IT WAS REPORTED AS UNRELATED TO THE ENTERPRISE VRD. ADDITIONALLY, IT WAS REPORTED THAT THE CAUSE OF THE EVENT (MI) WAS CONSIDERED TO BE THE WORSENING OF THE PATIENT'S CARDIOVASCULAR COMPLICATIONS, AND IT WAS MI THAT LEFT THE PATIENT WITH DISTURBANCE OF CONSCIOUSNESS. THE PATIENT HAS A HISTORY OF SUBARACHNOID HEMORRHAGE, HEART DISEASE, ABDOMINAL ANEURISM WHICH WAS TREATED WITH SURGERY, AND CLIPPING OF THE LEFT INTERNAL CAROTID ARTERY ANEURYSM, HOWEVER NO HISTORY OF DISTURBANCE OF CONSCIOUSNESS. NO COIL WAS PROTRUDING INTO THE PARENT ARTERIES. PRIOR OR DURING THE PROCEDURES, NO THROMBUS WAS NOTED AT THE SITES, AND AFTER THE STENT AND COILING PROCEDURES WERE COMPLETED, NO THROMBUS OR ANY OTHER ISSUES WERE NOTED AT THE SITES. THE ENTERPRISE STENTS WERE FULLY EXPANDED, APPOSE TO THE VESSEL WALL AND IN A STABLE POSITION AFTER PLACEMENT. THE PARENT VESSEL DIAMETER OF THE BASILAR TIP ANEURYSM WAS 1.5MM PROXIMALLY AND DISTALLY. THIS IS BELOW THE RECOMMENDED VESSEL DIAMETER AS OUTLINED IN THE INSTRUCTIONS FOR USE. USAGE OTHER THAN THE APPROVED LABELING MAY INVOLVE RISKS NOT DESCRIBED IN THE LABELING. THE STENTS REMAIN IMPLANTED AND PROCEDURAL/DIAGNOSTIC IMAGES ARE NOT AVAILABLE. LAKE REGION MEDICAL DID REVIEW THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01423721. 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. MYOCARDIAL INFARCTION AND NEUROLOGICAL CHANGES ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH PROCEDURES USING THE ENTERPRISE VRD IN THE INTRACRANIAL VASCULATURE AS OUTLINED IN THE INSTRUCTIONS FOR USE. AS REPORTED, THE PATIENT'S PRE-EXISTING MEDICAL CONDITION AND THE INHERENT RISK ASSOCIATED WITH INTERVENTIONAL PROCEDURES ARE FACTORS CONTRIBUTING TO THE REPORTED EVENTS. BASED ON THE REPORTED INFORMATION THERE IS NO INDICATION OF ENTERPRISE DEVICE PERFORMANCE OR MANUFACTURING ISSUES RELATED TO THE EVENT. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS IS ONE OF TWO PRODUCTS USED DURING THE SAME PROCEDURE ON THE SAME PATIENT, WHICH IS ASSOCIATED WITH MFG REPORT 1058196-2011-00481 AND 1058196-2011-00482.

    Description of Event or Problem · 1

    THE (B)(4) STUDY INDICATED THAT THE DAY AFTER THE STAGE PROCEDURE, THE PATIENT (B)(4) DEVELOPED MYOCARDIAL INFARCTION, AND WAS TREATED WITH ISOSORBIDE DINITRATE. THE EVENT OUTCOME AS FOUR MONTH POST EVENT IS "RECOVERED WITH SEQUELA (DISTURBANCE OF CONSCIOUSNESS)." PHYSICIAN'S COMMENTED THAT THE RELATIONSHIP OF THE EVENT TO THE ENTERPRISE WAS UNRELATED. ADDITIONALLY, AT ONE MONTH AFTER THE PROCEDURE, THE PATIENT MODIFIED RANKIN SCALES WAS 5, AND THE PATIENT'S CONDITION AS OF FOUR MONTHS WAS RECOVERED WITH SEQUEL, BUT NO FURTHER INFORMATION WAS AVAILABLE. BOTH TREATED ANEURYSMS REMAINED UNRUPTURED. THE PATIENT HAS A HISTORY OF SUBARACHNOID HEMORRHAGE, HEART DISEASE, ABDOMINAL ANEURISM WHICH WAS TREATED WITH SURGERY, AND CLIPPING OF THE LEFT INTERNAL CAROTID ARTERY ANEURYSM, HOWEVER NO HISTORY OF DISTURBANCE OF CONSCIOUSNESS. NO COIL WAS PROTRUDING INTO THE PARENT ARTERIES. PRIOR OR DURING THE PROCEDURES, NO THROMBUS WAS NOTED AT THE SITES, AND AFTER THE STENT AND COILING PROCEDURES WERE COMPLETED, NO THROMBUS OR ANY OTHER ISSUES WERE NOTED AT THE SITES. THE ENTERPRISE STENTS WERE FULLY EXPANDED, APPOSE TO THE VESSEL WALL AND IN A STABLE POSITION AFTER PLACEMENT. MEDICATION AT DISCHARGED CONSISTED OF ASPIRING AND CLOPIDOGREL SULFATE.

    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 01423721

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Life Threatening| R| S