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

Model Number 172020-CASJ

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

Patient Problem Thrombus (2101)

Event Date 07/14/2019

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 a patient enrolled in the lepi clinical trial was treated with an lvis stent for a recanalized saccular acomm artery aneurysm that had never ruptured and was previously treated with embolization coils.During the procedure, angiographic imaged demonstrated multiple small thrombus in the stent.Circulation in the anterior cerebral artery was still maintained.An iv bolus of reopro (25mg/kg) was administered intravenously.The patient's outcome was reported to be "resolved without sequelae on the same day." the patient was reported to be asymptomatic and was discharged with a mrs=0.The patient will continue to be monitored per clinical trial protocol.

Manufacturer Narrative

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.B5: additional information: the procedure report was received from the clinical site on (b)(6) 2019.Additional details indicate that the a-com aneurysm had a wide neck and stent-assisted coiling was performed, aided by the implantation of an lvis jr.Stent.The patient was placed on dual antiplatelet therapy for 3 months, followed by kargegic alone for up to one year.

• Brand Name: LVIS JR 2.5X23 MM
• Type of Device: STENT
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 8923827
• MDR Text Key: 155325145
• Report Number: 2032493-2019-00200
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• PMA/PMN Number: K130005
• 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: 07/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2020
• Device Model Number: 172020-CASJ
• Device Catalogue Number: 17100352A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR