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

Model Number	172020-LVISJ-C-HDE
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombus (2101)
Date of Event	05/10/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number was provided.A review of the approved device history record indicated the lot met all release criteria.A lot history trending review was performed and there were no similar complaints for this lot number.The stent remains implanted and the remainder of the device was discarded at the user facility; therefore, a product analysis could not be performed.The root cause cannot be determined.The instructions for use (ifu) identifies neurologic insufficiencies as a potential complication associated with use of the device.
Event or Problem Description
It was reported that stent-assisted coil embolization was attempted for a left mca bifurcation sacular aneurysm.The lvis jr.Stent was implanted without issue and a microcatheter was jailed in the aneurysm.After unsuccessful attempts were made to position two coils in the aneurysm, a focal area of acute thrombus began to form on the stent, which was successfully treated with reopro.The procedure was aborted in favor of completing the procedure at a later date.The patient experienced non-specific neurological deficits 24 hours post-procedure, per the physician.

• Brand Name: LVIS JR 2.5X23 (HDE)
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• MDR Report Key: 6632629
• Report Number: 2032493-2017-00137
• Device Sequence Number: 10985976
• Product Code: NJE
• UDI-Device Identifier: 00812636020143
• UDI-Public: (01)00812636020143(11)161108(17)191031(10)16110843
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K130005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/10/2017

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: Other
• Device Expiration Date: 10/31/2019
• Device Model Number: 172020-LVISJ-C-HDE
• Device Lot Number: 16110843
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2017
• Initial Report FDA Received Date: 06/09/2017
• 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: 72 YR