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

Model Number	172020-LVISJ-C-HDE
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	03/04/2016
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 aneurysm, a "y" stenting of the right middle cerebral artery (mca) bifurcation was performed.The first stent (lvis jr.) was successfully placed in the inferior branch.Multiple attempts were made to access the superior branch with the microcatheter and guide wire.However, during this attempt, the stent migrated into the mca.The stent was reported to help bridge the neck.A second stent was placed inside the first stent deployed and coils were placed in the aneurysm successfully.No patient harm or injury was reported.The patient was discharged the following day.

• 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: 5571990
• Report Number: 2032493-2016-00064
• Device Sequence Number: 13542373
• Product Code: NJE
• UDI-Device Identifier: 00812636020143
• UDI-Public: (01)00812636020143(11)151021(17)181021(10)15102128
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 03/09/2016

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
• Operator of Device: Physician
• Device Expiration Date: 10/21/2018
• Device Model Number: 172020-LVISJ-C-HDE
• Device Lot Number: 15102128
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2016
• Initial Report FDA Received Date: 04/12/2016
• 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: Life Threatening
• Patient Age: 81 YR
• Patient Weight: 64