MAUDE Adverse Event Report: MICROVENTION, INC. LVIS JR 2.5X23MM; STENT

Model Number	172020-LVISJ
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Neurological Deficit/Dysfunction (1982); Thrombus (2101)
Date of Event	02/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number was provided.A search for non-conformance associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The stent remains implanted in the patient; therefore, a product analysis could not be performed.The root cause is unknown.The instructions for use (ifu) identifies neurologic insufficiencies and thrombus as a potential complications associated with the use of the device.
Event or Problem Description
It was reported that approximately two (2) hours post stent-implantation, the patient presented with neurological decline and left hemisphere syndrome.Cta demonstrated a thrombotic occlusion of the upper branch of the stent construct.The patient was treated with ia integrelin.The event was resolved without sequelae three (3) days later.The patient was reported to have made a complete recovery.

• Brand Name: LVIS JR 2.5X23MM
• Common Device Name: STENT
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 8593173
• Report Number: 2032493-2019-00133
• Device Sequence Number: 2074987
• Product Code: NJE
• UDI-Device Identifier: 00842429100813
• UDI-Public: (01)00842429100813(11)180228(17)210131(10)18022852ZM
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K130005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/11/2019

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: 01/31/2021
• Device Model Number: 172020-LVISJ
• Device Catalogue Number: 172020-LVISJ
• Device Lot Number: 18022852ZM
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2019
• Initial Report FDA Received Date: 05/08/2019
• 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: 52 YR
• Patient Weight: 85