MAUDE Adverse Event Report: MICROVENTION, INC. LVIS JR 2.5X23; STENT

Model Number	172020-LVISJ
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombus (2101)
Date of Event	07/03/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number was provided.A review of the approved device history records 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 was implanted in the patient and the remainder of the device was discarded at the user facility; therefore, a product analysis could not be performed.The root cause is unknown.The instructions for use (ifu) identifies vascular occlusion as a potential complication associated with use of the device.
Event or Problem Description
It was reported that four (4) coils were successfully implanted in an a2 callosomarginal aneurysm.After implantation of a subsequent stent, the patient developed a clot within the distal portion of the stent, which shut down distal flow in the vessel.Reopro was administered, and the clot resolved.The patient was reported to have woken up with no symptoms, and is doing great.

• Brand Name: LVIS JR 2.5X23
• Common Device Name: STENT
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 7737762
• Report Number: 2032493-2018-00150
• Device Sequence Number: 920164
• Product Code: NJE
• UDI-Device Identifier: 00842429100813
• UDI-Public: (01)00842429100813(11)171024(17)200930(10)171024531M
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K130005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/03/2018

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: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: 172020-LVISJ
• Device Catalogue Number: 172020-LVISJ
• Device Lot Number: 171024531M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/03/2018
• Initial Report FDA Received Date: 07/31/2018
• 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: 35 YR
• Patient Weight: 110