MAUDE Adverse Event Report: MICROVENTION, INC. LVIS JR 3.5X18 MM; STENT

Model Number 172516-CASJ

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombus (2101)

Event Date 10/26/2018

Event Type  Injury  

Manufacturer Narrative

The lot number was not provided; therefore, a search for production-related ncrs could not be performed.The stent was implanted in the patient and the remainder of the device was not returned to the manufacturer; therefore, a product analysis could not be performed.The root cause is unknown.The instructions for use (ifu) identifies thrombus as a potential complication associated with use of the device.

Event Description

It was reported that on (b)(6) 2018, the patient was treated for a saccular aneurysm located in the internal carotid artery (supraclinoid segment), the patient's pre-procedure was mrs=0.The aneurysm had never ruptured and had been previously treated with coils.During the procedure, thrombus developed within the lvis jr.Stent, which gradually worsened.The thrombus was treated with reopro and an additional endovascular procedure (thrombectomy) was performed using a hyperglide balloon and a solitaire stentriever.Final angiography demonstrated a complete occlusion of the aneurysmal sac.The event was reported to be resolved without sequelae on the same day as the procedure.The event was classified as being without seriousness, with mild severity, and in terms of clinical impact, the patient was asymptomatic.Neurological evaluation of the patient at hospital discharge was mrs=1.At the 6-month follow-up visit on (b)(6) 2019, the neurological evaluation of the patient was mrs=0.Imaging demonstrated a complete and stable occlusion of the aneurysm and the parent artery remains without stenosis.The patient is enrolled in the lepi clinical trial and will be closely monitored per study protocol.

Manufacturer Narrative

Additional information provided in medical records received from the clinical site indicates that the lvis jr had been placed across the wide-necked aneurysm in the left m1 segment and in the termination of the left internal carotid artery to assist with coil implantation.The patient was prescribed dual antiplatelet therapy with plavix and kardegic for a minimum of 6 months, post-procedure.A search for non-conformances 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.

• Brand Name: LVIS JR 3.5X18 MM
• Type of Device: STENT
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 8952740
• MDR Text Key: 156873340
• Report Number: 2032493-2019-00208
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• PMA/PMN Number: P170013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 05/31/2020
• Device Model Number: 172516-CASJ
• Device Lot Number: 17060651A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PROWLER 10 MICROCATHETER
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR