MAUDE Adverse Event Report: MICROVENTION, INC. LVIS JR 3.5X18 (HDE); STENT

Model Number	172516-LVISJ
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Thrombus (2101); Numbness (2415)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number was provided.A lot history trending review was performed and there were no similar complaints for this lot number.The stent remains implanted and the delivery system 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 thrombus as a potential complication associated with use of the device.
Event or Problem Description
It was reported that the lvis jr.Was implanted during stent-assisted coiling of an aneurysm at the right mca bifurcation.There was no reported difficulty deploying the stent at the treatment site.During the procedure, an in-stent thrombus developed and a balloon was used for treatment.Coils were successfully placed in the aneurysm and the thrombus was completely resolved by the end of the procedure.The patient was placed on (b)(6) as dual antiplatelet therapy (dapt), post-procedure.On (b)(6) 2018, approximately one month after the procedure, the patient had a 20-minute episode of left arm numbness and did not have the ability to use her arm during that time.Five days later on (b)(6) 2018, the patient had a second episode with the same symptoms.The patient was admitted to the hospital and detailed imaging studies were performed.It was reported that there was no evidence by imaging of emboli or restricted blood flow.The patient's (b)(6) dosage was increased.A review of images provided by the customer indicated the stent did not appear to be fully apposed to the vessel wall.The patient is reported to be stable and has not had any recurrence of symptoms since her last episode on (b)(6) 2018.The stent remains implanted.

• Brand Name: LVIS JR 3.5X18 (HDE)
• Common Device Name: STENT
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 7547162
• Report Number: 2032493-2018-00097
• Device Sequence Number: 19146003
• Product Code: NJE
• UDI-Device Identifier: 00811425029893
• UDI-Public: (01)00811425029893(11)170117(17)191231(10)17011733
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K130005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/27/2018

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?: Yes
• Operator of Device: Other
• Device Expiration Date: 12/31/2019
• Device Model Number: 172516-LVISJ
• Device Catalogue Number: 172516-LVISJ
• Device Lot Number: 17011733
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/27/2018
• Initial Report FDA Received Date: 05/26/2018
• 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: Hospitalization; Required Intervention