BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 2984138 · Received February 28, 2013

    Report

    Report Number
    1058196-2013-00055
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    April 2, 2012
    Report Date
    February 7, 2013
    Manufacturer
    CORDIS NEUROVASCULAR, INC.
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE TWO REPORTED INTRACRANIAL HEMORRHAGES IN PATIENTS PRESENTING WITH UNRUPTURED ANEURYSMS. ONE OCCURRED 24 HOURS POST OPERATIVELY, ON ASPIRIN AND PLAVIX. ONE HAD A PARENCHYMAL INTRACRANIAL HEMORRHAGE 3.5 MONTHS POST-OPERATIVELY ON ASPIRIN AND PLAVIX. THE MEAN AGE AT TIME OF ENTERPRISE STENT DEPLOYMENT WAS 57.3 6 0.81 YEARS (MEDIAN, 59 YEARS; RANGE, 15-83 YEARS) AND WOMEN REPRESENTED 81%OF THE STUDY PATIENTS. THE MAJORITY OF TREATED ANEURYSMS WERE INTERNAL CAROTID ARTERY ANEURYSMS, WITH OPHTHALMIC SEGMENT (26.6%). MEAN ANEURYSM SIZE WAS 9.2 +/- 0.4 MM (MEDIAN, 7.0; RANGE, 1.5-35.0 MM). MEAN PARENT VESSEL SIZE WAS 3.3 +/- 0.1 MM (MEDIAN, 3.3 MM; RANGE, 1.5-5.7MM). THE AUTHORS CONCLUDED THAT ALTHOUGH THE STUDY IS LIMITED IN ITS RETROSPECTIVE NATURE THE ENTERPRISE STENT SYSTEM APPEARS TO BE AN EFFECTIVE, SAFE AND DURABLE TREATMENT FOR INTRACRANIAL ANEURYSMS WHEN USED IN CONJUNCTION WITH COILING. CONCLUSION: INFORMATION VIA A LITERATURE REVIEW WAS NOTED IN FARGEN, KYLE M., ET AL, 'LONG-TERM RESULTS OF ENTERPRISE STENT-ASSISTED COILING OF CEREBRAL ANEURYSMS;' NEUROSURGERY VOL. 71, NO. 2, 8-2012. NINE CENTERS PROVIDED DE-IDENTIFIED DATA ON ALL CONSECUTIVE PATIENTS WHO UNDERWENT ENTERPRISE VRD DEPLOYMENT AS PART OF ANEURYSM TREATMENT PRIOR TO (B)(6) 2009; 229 PATIENTS WITH 229 ANEURYSMS WERE INCLUDED IN THE STUDY. THERE WERE THREE DEATHS RELATED TO INTRACRANIAL HEMORRHAGE AND ONE DEATH DUE TO A PERIPROCEDURAL MYOCARDIAL INFARCTION. THERE WERE THREE INTRACRANIAL HEMORRHAGES WITHOUT DEATH OF THE PATIENT. THERE WERE 10 REPORTED THROMBOEMBOLIC EVENTS, 7 REPORTS OF INSTENT RESTENOSIS (3 LESS THAN 50%, 3 APPROXIMATELY 50%, AND ONE GREATER THAN 50%), ATTEMPTED COILING WAS NOT ACCOMPLISHED SECONDARY TO STENT PROLAPSE IN ONE PATIENT, KINKED STENT IN ONE PATIENT AND REPEATED COIL PROLAPSE IN ONE PATIENT. THERE WAS ONE REPORT OF IATROGENIC CAROTID CAVERNOUS FISTULA. THERE IS NO UNIQUE IDENTIFYING PATIENT, TARGET SITE, EVENT DESCRIPTION, OR HOSPITAL INFORMATION. THE MEAN AGE AT TIME OF ENTERPRISE STENT DEPLOYMENT WAS 57.3 6 0.81 YEARS (MEDIAN, 59 YEARS; RANGE, 15-83 YEARS) AND WOMEN REPRESENTED 81%OF THE STUDY PATIENTS. THE MAJORITY OF TREATED ANEURYSMS WERE INTERNAL CAROTID ARTERY ANEURYSMS, WITH OPHTHALMIC SEGMENT (26.6%). MEAN ANEURYSM SIZE WAS 9.2 +/- 0.4 MM (MEDIAN, 7.0; RANGE, 1.5-35.0 MM). MEAN PARENT VESSEL SIZE WAS 3.3 +/- 0.1 MM (MEDIAN, 3.3 MM; RANGE, 1.5-5.7MM). THE AUTHORS CONCLUDED THAT ALTHOUGH THE STUDY IS LIMITED IN ITS RETROSPECTIVE NATURE THE ENTERPRISE STENT SYSTEM APPEARS TO BE AN EFFECTIVE, SAFE AND DURABLE TREATMENT FOR INTRACRANIAL ANEURYSMS WHEN USED IN CONJUNCTION WITH COILING. THE DEVICES REMAIN IMPLANTED AND THE LOT NUMBERS ARE NOT KNOWN; THEREFORE A DEVICE HISTORY RECORD REVIEW CANNOT BE COMPLETED. THERE WERE TWO REPORTED INTRACRANIAL HEMORRHAGES IN PATIENTS PRESENTING WITH UNRUPTURED ANEURYSMS. ONE OCCURRED 24 HOURS POST OPERATIVELY, ON ASPIRIN AND PLAVIX. ONE HAD A PARENCHYMAL INTRACRANIAL HEMORRHAGE 3.5 MONTHS POST-OPERATIVELY ON ASPIRIN AND PLAVIX. INTRACRANIAL HEMORRHAGE IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE USE OF THE ENTERPRISE VRD IN THE INTRACRANIAL VASCULATURE AS OUTLINED IN THE INSTRUCTIONS FOR USE. IT IS POSSIBLE THAT CLINICAL FACTORS INCLUDING PATIENT COMORBIDITY MAY HAVE IMPACTED THE EVENTS. HOWEVER, BASED ON THE AVAILABLE INFORMATION, NO CONCLUSION CAN BE MADE REGARDING THE CAUSE OF THE EVENTS OR THE RELATIONSHIP TO THE ENTERPRISE VRD. THEREFORE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    INFORMATION VIA A LITERATURE REVIEW WAS NOTED IN FARGEN, KYLE M., ET AL, 'LONG-TERM RESULTS OF ENTERPRISE STENT-ASSISTED COILING OF CEREBRAL ANEURYSMS;' NEUROSURGERY VOL. 71, NO. 2, 8-2012. NINE CENTERS PROVIDED DE-IDENTIFIED DATA ON ALL CONSECUTIVE PATIENTS WHO UNDERWENT ENTERPRISE VRD DEPLOYMENT AS PART OF ANEURYSM TREATMENT PRIOR TO (B)(6) 2009; 229 PATIENTS WITH 229 ANEURYSMS WERE INCLUDED IN THE STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86004 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM CNV ENTERPRISE SES (NJE) NJE CORDIS NEUROVASCULAR, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1