MAUDE Adverse Event Report: MICROVENTION, INC. LVIS JR 2.5X23 (HDE); INTRALUMINAL STENT

Model Number	172020-LVISJ-C-HDE
Medical Device Problem Codes	Positioning Problem (3009); Unintended Movement (3026)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	03/18/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This device is used for treatment, not diagnosis.The lvis jr.Device is intended for use with embolic coils for the treatment of intracranial neurovascular diseases.Use of the lvis jr.Device is contraindicated under these circumstances: patients in whom anticoagulant, antiplatelet therapy or thrombolytic drugs are contraindicated.Patients with known hypersensitivity to nickel-titanium.Patients with anatomy that does not permit passage or deployment.Per the instructions for use, possible complications include but are not limited to the following: bleeding or hemorrhage including intracerebral, retroperitoneal or other locations.Complications of arterial puncture including pain, local bleeding (hematoma) or injury to the artery or adjacent nerves.Device migration.Distal embolization.Headache.Incomplete aneurysm occlusion.Neurologic deficits including stroke and/or death.Perforation or dissection of the vessel(s).Pseudoaneurysm formation.Rupture or perforation of aneurysm.Transient ischemic attack (tia) or ischemic stroke.Vasospasm.Vessel occlusion.Vessel stenosis or thrombosis.Based on the information provided, the complaint cannot be confirmed.The device could not be evaluated as it was reported not available.(b)(4).
Event or Problem Description
It was reported that during the treatment of an acomm aneurysm, microcatheters were positioned to access the aneurysm for coil deployment.An lvis jr.Was placed to deploy from the left a2 across the acomm and shoulder it to protect the right a2 during coiling.During the deployment, the stent opened well distally, but the catheter straightened out the vessel.Due to the straightening, it was not possible to shoulder the lvis jr.Well enough to protect the right a2.Attempts were made to position the stent and catheter in the desired location unsuccessfully.At this point an attempt was made to pull the lvis jr.Into the envoy catheter.During this attempt the lvis jr.Deployed in the cavernous segment of the rica.The right a1 was filling slower at this point.An attempt was made to retrieve the lvis jr.Using a solitaire stent unsuccessfully.A 3mm gooseneck snare was utilized to retrieve the stent successfully on the first attempt.A follow up run showed spasm in the right mca artery along with some clot in the proximal section of the m1.After a couple minutes of minutes another angio run was performed which showed the clot cleared up.The a1 segment was filling much better at this point.However, there was still spasm in the right m1.At this point the catheters were withdrawn.A 6f sheath was left in place as they were planning on taking the patient to the or to clip the aneurysm, since they weren't able to treat it endovascularly.Additional patient/incident information provided on 4/13/2016- the patient was neurologically stable and at baseline when they woke the patient up after the case.The patient then went on to have the aneurysm clipped.

• Brand Name: LVIS JR 2.5X23 (HDE)
• Common Device Name: INTRALUMINAL STENT
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• MDR Report Key: 5574974
• Report Number: 2032493-2016-00069
• Device Sequence Number: 13535792
• Product Code: NJE
• UDI-Device Identifier: 00812636020143
• UDI-Public: (01)00812636020143(11)151002(17)181002(10)15100228
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/18/2016

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?: Yes
• Operator of Device: Physician
• Device Expiration Date: 10/02/2016
• Device Model Number: 172020-LVISJ-C-HDE
• Device Lot Number: 15100228
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2016
• Initial Report FDA Received Date: 04/13/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR