BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 2772399 · Received October 4, 2012

    Report

    Report Number
    1058196-2012-00372
    Event Type
    Injury
    Date Received
    October 4, 2012
    Date of Event
    September 27, 2011
    Report Date
    September 18, 2012
    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

    IT WAS REPORTED VIA THE (B)(4) ENTERPRISE CLINICAL "(B)(4) PMS ENTERPRISE" THAT APPROXIMATELY SIX MONTHS POST ENTERPRISE VRD (ENC452812/01427228) ASSISTED COIL EMBOLIZATION OF A LEFT PARASELLAR ANEURYSM THE PATIENT HAD AN EPISODE OF CEREBRAL INFARCTION OF THE LEFT PARASELLAR AND DEVELOPED RIGHT SIDED PARALYSIS. THE ADMINISTRATION OF CLOPIDOGREL SULFATE WAS RE-STARTED. THE EVENT OUTCOME AS OF 15 DAYS LATER WAS RESOLVED WITHOUT SEQUELAE. ACCORDING TO THE PHYSICIAN THE RELATIONSHIP OF THE EVENT TO THE PROCEDURE WAS UNRELATED AND TO THE VRD WAS UNKNOWN. THE ENTERPRISE STENT WAS FULLY EXPANDED AND APPOSE TO THE VESSEL WALL. THE STENT WAS FULLY PATENT AND NO THROMBUS WAS SEEN IN THE TREATED VESSEL AND NO COIL PROTRUSION. AT BASELINE THE (B)(6) FEMALE HAD A MEDICAL HISTORY OF CARDIOVASCULAR DISEASE, GASTRIC ULCER, HYPERTENSION AND ABNORMAL CARDIAC RHYTHM. THERE IS NO FURTHER INFORMATION AVAILABLE REGARDING THE CARDIAC ARRHYTHMIA. THE UNRUPTURED SACCULAR ANEURYSM NECK WAS 7.4MM, AND THE NECK TO SAC RATIO WAS 7.4:10.0MM. THE PARENT VESSEL SIZE DIAMETER PROXIMAL WAS 3.3MM AND DISTALLY WAS 2.8MM. THE MODIFIED RANKIN SCALE (MRS) SCORE PRE-PROCEDURE, FOUR DAYS AND THREE MONTHS POST PROCEDURE WAS 0. THE ACT WAS 106 SECONDS PRE ANTICOAGULATION. HEPARIN 4,000U WAS ADMINISTERED INTRA-PROCEDURALLY AND THE ACT WAS 219 SECONDS POST ANTICOAGULATION. A TOTAL OF 14 COILS WERE PLACED WITH AN ANEURYSM OCCLUSION RATE OF 80% AFTER THE PROCEDURE. THE ENTERPRISE STENT WAS FULLY EXPANDED AND APPOSE TO THE VESSEL WALL AND WAS FULLY PATENT. IT IS UNKNOWN WHY THE ANEURYSM WAS NOT PACKED FURTHER. AT THE TIME OF FOLLOW-UP ANGIOGRAM SIX MONTHS POST INDEX PROCEDURE, THE ANEURYSM NECK WAS 7.1MM, AND THE NECK TO SAC RATIO WAS 7.1:11.0MM. THE PARENT VESSEL SIZE DIAMETER PROXIMAL WAS 3.2MM AND DISTALLY WAS 2.7MM. THE OCCLUSION RATE OF ANEURYSM WAS 95%. THE MRS SCORE ONE YEAR POST INDEX PROCEDURE WAS 0. ANTIPLATELET THERAPY INCLUDED ONGOING ASPIRIN 100MG/DAY BEGINNING EIGHT DAYS PRE-INDEX PROCEDURE AND CLOPIDOGREL SULFATE 75MG/DAY BEGINNING EIGHT DAYS PRE-INDEX PROCEDURE FOR THREE MONTHS AND THEN RESUMED AND ONGOING THREE DAYS AFTER THE REPORTED ADVERSE EVENT. THE ENTERPRISE VRD REMAINS IMPLANTED. LAKE REGION MEDICAL REVIEWED THE DEVICE HISTORY RECORDS RELATIVE TO THE MANUFACTURING, INSPECTING AND PACKAGING OF LOT 01427228. 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. CEREBRAL INFARCTION IS KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH NEUROVASCULAR STENT IMPLANTATION PROCEDURES AND IS LISTED IN THE INSTRUCTIONS FOR USE AS SUCH. BASED ON THE AVAILABLE INFORMATION AND AS REPORTED THE RELATIONSHIP OF THE CEREBRAL INFARCTION AND THE ENTERPRISE VRD CANNOT BE DETERMINED. HOWEVER, WITH REVIEW OF THE AVAILABLE INFORMATION THERE IS NO INDICATION OF ANY DEVICE PERFORMANCE ISSUES IMPACTING THE EVENT. PATIENT FACTORS INCLUDING HISTORY OF CARDIAC ARRHYTHMIA, PHARMACOLOGICAL AND CLINICAL FACTORS MAY HAVE CONTRIBUTED. WITH REVIEW OF THE AVAILABLE INFORMATION AND THE DEVICE HISTORY RECORDS THERE IS NO INDICATION OF ANY RELATED MANUFACTURING ISSUES; THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    NOTE: CONCOMITANT DEVICES USED: EXCELSIOR SL10, TWO CHIKAI/ASAHI (B)(4),THREE V-TRACK/TERUMO, AND SEVEN GDC/STRYKER. (B)(4). THE PRODUCT WILL BE RETURNED FOR EVALUATION AND TESTING. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS.

    Description of Event or Problem · 1

    THE REPORT FROM (B)(6) STUDY INDICATED THAT THE INDEX PROCEDURE TOOK PLACE 18 MONTHS AGO. THE PROCEDURE WAS COIL EMBOLIZATION ASSISTED WITH VRD ((B)(4)) OF LEFT PARACELLAR.SIX MONTHS AFTER, THE PATIENT HAD AN EPISODE OF CEREBRAL INFARCTION OF LEFT PARACELLAR AND DEVELOPED A RIGHT-SIDED PARALYSIS. THE ADMINISTRATION OF CLOPIDOGREL SULFATE WAS RE-STARTED. THE EVENT OUTCOME SEVEN MONTHS AFTER THE INDEX PROCEDURE WAS 'RESOLVED WITHOUT SEQUEALE'. ACCORDING TO THE PHYSICIAN THE RELATIONSHIP OF THE EVENT TO THE PROCEDURE WAS UNRELATED AND TO THE VRD WAS UNK. THE PATIENT HAD MEDICAL HISTORIES OF CARDIOVASCULAR DISEASE, GASTRIC ULCER, HYPERTENSION AND ABNORMAL CARDIAC RHYTHM. THE UNRUPTURED SACCULAR ANEURYSM NECK WAS 7.4MM, AND THE NECK TO SAC RATIO WAS 7.4:10.0MM. THE PARENT VESSEL SIZE DIAMETER PROXIMAL WAS 3.3MM AND DISTALLY WAS 2.8MM. MR ON REMAINED AT 0. THE ACT WAS 106 SECONDS PRE ANTICOAGULATION AND 219 SECONDS POST ANTICOAGULATION. NO INFORMATION REGARDING INR, PT, AND PTT. THE OCCLUSION RATE OF ANEURYSM WAS 80% AFTER THE PROCEDURE. IT IS UNKNOWN WHY THE ANEURYSM WAS NOT PACKED FURTHER. AT THE TIME OF FOLLOW-UP ANGIOGRAM, THE ANEURYSM NECK WAS 7.1MM, AND THE NECK TO SAC RATIO WAS 7.1:11.0MM. THE PARENT VESSEL SIZE DIAMETER PROXIMAL WAS 3.2MM AND DISTALLY WAS 2.7MM. THE OCCLUSION RATE OF ANEURYSM WAS 95%, MRS WAS 0. ANTIPLATELET THERAPY INCLUDED ASPIRIN 100MG/DAY: ONGOING, CLOPIDOGREL SULFATE 75MG/DAY: ONGOING, HEPARIN 4,000U WAS ADMINISTERED INTRA-PROCEDURALLY. PRIOR TO IMPLANTING THE VRD, LANCHER/MEDTRONIC, (B)(4)(LOT UNKNOWN), CHIKAI/ASAHI (B)(4). OTHER DEVICES UTILIZED DURING THE PROCEDURE WERE, EXCELSIOR SL10, TWO CHIKAI/ASAHI (B)(4), (B)(4), THREE V-TRACK/TERUMO, AND SEVEN GDC/STRYKER. NO FURTHER INFO AVAILABLE.

    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 01427228

    Patients

    Seq Age Sex Outcome Treatment
    1