BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM

    MDR report key: 2984171 · Received February 28, 2013

    Report

    Report Number
    1058196-2013-00063
    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

    AT FOLLOW-UP, THREE PATIENTS HAD IN-STENT STENOSIS OF APPROXIMATELY 50%. ON REINSTITUTION OF PLAVIX (CLOPIDOGREL) THE STENOSIS OF ONE OF THESE PATIENTS IMPROVED TO ONLY 17%. AT FOLLOW-UP, ONE PATIENT HAD IN-STENT STENOSIS OF GREATER THAN 50%. ON REINSTITUTION OF PLAVIX (CLOPIDOGREL) THE STENOSIS RESOLVED ENTIRELY. DEVELOPMENT OF STENOSIS WAS NOT ASSOCIATED WITH PARENT VESSEL DIAMETER OR VESSEL TORTUOSITY. IT IS REPORTED THAT 50% OR GREATER STENOSIS IS A THRESHOLD GENERALLY CONSIDERED TO BE SIGNIFICANT/REPORTABLE. A TOTAL OF (B)(4) PATIENTS ((B)(4)) UNDERWENT FOLLOW-UP ANGIOGRAPHY WITH A MEAN ANGIOGRAPHIC FOLLOW-UP AT APPROXIMATELY 21 MONTHS (655.7 +/- 25.2 DAYS). A TOTAL OF (B)(4) PATIENTS ((B)(4)) HAD CLINICAL FOLLOW-UP AT APPROXIMATELY 20 MONTHS (MEAN 619.6 +/- 26.4 DAYS. THE MEAN AGE AT TIME OF ENTERPRISE STENT DEPLOYMENT WAS (B)(6) AND WOMEN REPRESENTED (B)(4) OF THE STUDY PATIENTS. THE MAJORITY OF TREATED ANEURYSMS WERE INTERNAL CAROTID ARTERY ANEURYSMS, WITH OPHTHALMIC SEGMENT ((B)(4)). 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 MAY 2009. (B)(4) PATIENTS WITH (B)(4) 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 (B)(4) REPORTED THROMBOEMBOLIC EVENTS, (B)(4) REPORTS OF INSTENT RESTENOSIS ((B)(4)), 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 (B)(6) AND WOMEN REPRESENTED (B)(6) OF THE STUDY PATIENTS. THE MAJORITY OF TREATED ANEURYSMS WERE INTERNAL CAROTID ARTERY ANEURYSMS, WITH OPHTHALMIC SEGMENT ((B)(4)). 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. AT FOLLOW-UP, THREE PATIENTS HAD IN-STENT STENOSIS OF APPROXIMATELY 50%. ON REINSTITUTION OF PLAVIX (CLOPIDOGREL) THE STENOSIS OF ONE OF THESE PATIENTS IMPROVED TO ONLY 17%. AT FOLLOW-UP, ONE PATIENT HAD IN-STENT STENOSIS OF GREATER THAN 50%. ON REINSTITUTION OF PLAVIX (CLOPIDOGREL) THE STENOSIS RESOLVED ENTIRELY. DEVELOPMENT OF STENOSIS WAS NOT ASSOCIATED WITH PARENT VESSEL DIAMETER OR VESSEL TORTUOSITY. IT IS REPORTED THAT 50% OR GREATER STENOSIS IS A THRESHOLD GENERALLY CONSIDERED TO BE SIGNIFICANT/REPORTABLE. A TOTAL OF (B)(4) PATIENTS ((B)(4)) UNDERWENT FOLLOW-UP ANGIOGRAPHY WITH A MEAN ANGIOGRAPHIC FOLLOW-UP AT APPROXIMATELY 21 MONTHS (655.7 +/- 25.2 DAYS). A TOTAL OF (B)(4) PATIENTS ((B)(4)) HAD CLINICAL FOLLOW-UP AT APPROXIMATELY 20 MONTHS (MEAN 619.6 +/- 26.4 DAYS. AS CITED IN THE INSTRUCTIONS FOR USE, STENOSIS OF THE STENTED ARTERY SEGMENT IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH INTRACRANIAL STENT PLACEMENT. UNDERLYING PATIENT AND PROCEDURAL FACTORS MAY PLAY A ROLE IN THE INTIMAL HYPERPLASIA; HOWEVER, WITHOUT FURTHER INFORMATION NO CONCLUSION CAN BE MADE REGARDING THE REPORTED EVENT. THIS IS ONE OF NINE REPORTS INVOLVED WITH THIS LITERATURE ARTICLE, WHICH IS ASSOCIATED WITH MFG REPORTS 1058196-2013-00055, 1058196-2013-00056, 1058196-2013-00057, 1058196-2013-00058, 1058196-2013-00059, 1058196-2013-00060, 1058196-2013-00061, 1058196-2013-00062, AND 1058196-2013-00063.

    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 MAY 2009. (B)(4) PATIENTS WITH (B)(4) ANEURYSMS WERE INCLUDED IN THE STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87331 ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM CNV ENTERPRISE SES (NJE) NJE CORDIS NEUROVASCULAR, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1