MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM; CNV ENTERPRISE SES (NJE)

Catalog Number UNKENTERPRISEENC

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Transient Ischemic Attack (2109)

Event Date 03/12/2015

Event Type  Injury  

Event Description

It was reported in literature article ¿the safety and efficacy of triple antiplatelet therapy after intracranial stent-assisted coil embolization¿ by yoshihisa matsumoto, md, phd, minoru iko, md, phd, masanori tsutsumi, md, phd, takahumi mitsutake, md, ayumu eto, md, kouhei nii, md, phd, kanji nakai, md, phd, hiromichi oishi, md, hiroshi aikawa, md, phd, and kiyoshi kazekawa, md, phd, published in journal of stroke and cerebrovascular diseases, vol.24, no.7 (july), 2015: pp 1513-1519, that there was one event of hemiparesis, 2 cerebral infarctions and 5 tia¿s associated with enterprise vrd stent implantation.Stent-assisted coil embolization for intracranial aneurysms increases packing density and decreases the coil deviation rates of the parent artery, and it is especially useful for wide-necked aneurysms.However, this procedure is associated with thromboembolic events.The optimal antiplatelet agent regimen for patients who have undergone intracranial stent-assisted coil embolization has not yet been established.Between july 2010 and may 2014, retrospective data was collected on patients with unruptured intracranial aneurysms or during the chronic phase of ruptured intracranial aneurysms.The enterprise vrd was used in 53 cases.Postoperative ischemic events primarily consisted of cerebral infarction, transient ischemic attack (tia), or eye symptoms.There was 1 case of hemiparesis on the side opposite of the stented vessel found immediately after the operation.78 patients (19 men and 59 women) with 79 cases were included in post-operative monitoring.Clinical outcomes 140 days postoperatively showed that 7 of the 79 cases in the dual group experienced postoperative ischemic events evidenced by dysarthria and/or motor weakness and/or sensory disturbance on the side opposite of the stented vessel, which indicated the legion of the stented vessel.Cerebral infarction was diagnosed in 2 patients.Their symptoms were mild, and they were discharged without assistance.Tia was diagnosed in 5 patients at 1, 3, 9, 12, and 40 days postoperatively.None of these 7 cases displayed evidence of in-stent stenosis of over 30% on angiographic follow-up, and cardiogenic embolic risk factors, including arterial fibrillation, were not present.Postoperative ischemic events did not occur in the triple group.There was no specific product or procedural issue noted.The product did not present any visual anomaly and there were no functional issues associated with the products during the referenced procedures that caused postoperative complications.

Manufacturer Narrative

The stents remain implanted thus unavailable for analysis and no sterile lot number information has been available so no dhr could be performed.Neurologic deficits, cerebral infarctions and tias are known potential adverse events associated with the use of the enterprise device and are listed in the ifu as such.All products undergo a 100% inspection prior to being released for sale; there is no evidence of a manufacturing issue related to this complaint.Review of the available information suggests target site, lesion characteristics, patient and medication factors may have all contributed to the reported events.This report is related to report #'s 1058196-2015-00157 and 1058196-2015-00158 udi: unknown part number, product is implanted and not available, udi is unavailable.

• Brand Name: ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM
• Type of Device: CNV ENTERPRISE SES (NJE)
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA
• Manufacturer Contact: kimberly soter ; 14700 nw 57th court; miami lakes, FL 33014 ; 5089777396
• MDR Report Key: 4966090
• MDR Text Key: 20775182
• Report Number: 1058196-2015-00159
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• PMA/PMN Number: H60001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Consumer,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2015
• 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
• Date Manufacturer Received: 07/15/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention