MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM; INTRACRANIAL NEUROVASCULAR STENT

Catalog Number UNKENTERPRISEENC

Device Problem Occlusion Within Device (1423)

Patient Problems Neurological Deficit/Dysfunction (1982); Transient Ischemic Attack (2109)

Event Date 11/26/2015

Event Type  Injury  

Manufacturer Narrative

Concomitant medications: aspirin 325mg/day and thienopyridine derivative 7 days prior to the index procedure, clopidogrel 75 mg/day and aspirin 75 to 325 mg/day post procedure.Three attempts to obtain additional information, including the date of the procedure and device catalog number, lot number, manufacture date and expiration dates were unsuccessful.Literature article attached to this mdr report: brasiliense l.B, yoon j.W., orina j.N., et al.(01 feb 2016).A reappraisal of anterior communicating artery aneurysms: a case for stent-assisted embolization, neurosurgery.78 (2) (pp 200-207), 2016.Udi: unknown part number, all 3 attempts to obtain product were unsuccessful, udi unavailable as reported via the literature article a reappraisal of anterior communicating artery aneurysms: a case for stent-assisted embolization by: brasiliense l.B.C.; yoon j.W.; orina j.N.Et al, (2016), patient # 17 experienced in-stent restenosis, transient ischemic attacks and gait difficulty after implantation of an enterprise stent.During the index procedure, the patient underwent stent assisted coil embolization of an incidentally discovered aneurysm 14mm in size.Digital subtracted angiography showed a large bi-lobed aneurysm arising from the anterior communicating artery and cross-filling of the contralateral a2 segment.An enterprise stent (lot unknown) was placed from the ipsilateral a1 to the contralateral a2 to obtain adequate coverage of the neck and the irregular aneurysm sac was coiled sequentially until minimal opacification was noted on contrast injections; the aneurysm was coiled though the struts of the stent.The patient presented with ischemic complications post-operatively.The patient developed transient ischemic attacks and gait difficulty approximately 3 months after the procedure following discontinuation of clopidogrel.Follow-up digital subtracted angiography 7 months after treatment revealed severe in-stent stenosis (80%) and persistent occlusion of the aneurysm.The patient was restarted on dual antiplatelet therapy, and the authors performed an uneventful balloon angioplasty of the stenotic segment with adequate reopening and filling of the distal segments of the anterior cerebral artery.Angiography revealed significant improvement of the stenosis and stable occlusion of the aneurysm without evidence of aneurysm recurrence.The patient had a partial recovery on clinical exam (b)(4).The purpose of the study described in the article was to assess the long-term clinical and angiographic outcomes of stent-assisted embolization for wide-necked anterior communicating artery aneurysms.Between march 2008 and march 2014, 32 patients with unruptured wide necked anterior communicating artery aneurysms were treated using stent-assisted embolization.The mean aneurysm size was 7.3mm (range, 3.2-23.0 mm) and all lesions had a wide-neck (dome-to-neck ratio.2) and were considered unfavorable for primary coiling.In all cases, only 1 stent was used.There were no peri-procedural thromboembolic or hemorrhagic complications.The device was not available for analysis.In addition, the lot number could not be obtained; therefore, a dhr review could not be performed.Stenosis of the stented segment and neurological deficit are known potential adverse events associated with the use of the enterprise vrd as outlined in the instructions for use.Underlying patient and procedural factors may play a role; however, based on the available information, no conclusion can be made regarding possible contributing factors.There is no indication of any manufacturing issues related to the event.Therefore, no corrective actions will be taken.This is an initial/final mdr report.Three attempts to obtain additional information, including the date of the procedure and device catalog number, lot number, manufacture date and expiration dates were unsuccessful.

Event Description

As reported via the literature article a reappraisal of anterior communicating artery aneurysms: a case for stent-assisted embolization by: brasiliense l.B.C.; yoon j.W.; orina j.N.; miller d.A.; tawk r.G.; hanel r.A.Neurosurgery.78 (2) (pp 200-207), 2016.Date of publication: 01 feb 2016, patient # 17 experienced in-stent restenosis, transient ischemic attacks and gait difficulty after implantation of an enterprise stent.During the index procedure, the patient underwent stent assisted coil embolization of an incidentally discovered aneurysm 14mm in size.Digital subtracted angiography showed a large bi-lobed aneurysm arising from the anterior communicating artery and cross-filling of the contralateral a2 segment.An enterprise stent (lot unknown) was placed from the ipsilateral a1 to the contralateral a2 to obtain adequate coverage of the neck and the irregular aneurysm sac was coiled sequentially until minimal opacification was noted on contrast injections; the aneurysm was coiled though the struts of the stent.The patient presented with ischemic complications post-operatively.The patient developed transient ischemic attacks and gait difficulty approximately 3 months after the procedure following discontinuation of clopidogrel.Follow-up digital subtracted angiography 7 months after treatment revealed severe in-stent stenosis (80%) and persistent occlusion of the aneurysm.The patient was restarted on dual antiplatelet therapy, and the authors performed an uneventful balloon angioplasty of the stenotic segment with adequate reopening and filling of the distal segments of the anterior cerebral artery.Angiography revealed significant improvement of the stenosis and stable occlusion of the aneurysm without evidence of aneurysm recurrence.The patient had a partial recovery on clinical exam (b)(4).The purpose of the study described in the article was to assess the long-term clinical and angiographic outcomes of stent-assisted embolization for wide-necked anterior communicating artery aneurysms.Between march 2008 and march 2014, 32 patients with unruptured wide necked anterior communicating artery aneurysms were treated using stent-assisted embolization.The mean aneurysm size was 7.3mm (range, 3.2-23.0 mm) and all lesions had a wide-neck (dome-to-neck ratio.2) and were considered unfavorable for primary coiling.In all cases, only 1 stent was used.There were no peri-procedural thromboembolic or hemorrhagic complications.

• Brand Name: ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM
• Type of Device: INTRACRANIAL NEUROVASCULAR STENT
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA
• Manufacturer Contact: karen anigbo ; 325 paramount dr; raynham, MA 02767 ; 5088288374
• MDR Report Key: 6095460
• MDR Text Key: 59721513
• Report Number: 1226348-2016-00166
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H60001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKENTERPRISEENC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/20/2016
• Initial Date FDA Received: 11/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR