MAUDE Adverse Event Report: MICROVENTION, INC. LVIS JR 2.5X17; INTRALUMINAL SUPPORT DEVICE

Model Number MV-L251717

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

Patient Problem Thrombus (2101)

Event Date 03/31/2020

Event Type  Injury  

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.The device was not returned to the manufacturer for analysis.The root cause cannot be determined.The instructions for use (ifu) identifies thrombosis as a potential complication associated with use of the device.

Event Description

It was reported that stent-assisted coiling was performed for an aneurysm in the anterior communicating artery.After the lvis jr.Was implanted and coils were placed in the aneurysm, angiography revealed in-stent thrombosis and it appeared that part of an implanted coil extended out of the aneurysm.Another company's stent was implanted at the treatment site within the stent using a y-configured technique.Heparin was increased, urokinase was injected, and balloon dilatation catheters were also used for treatment.It was confirmed that there was no health damage to the patient or sequelae.

• Brand Name: LVIS JR 2.5X17
• Type of Device: INTRALUMINAL SUPPORT DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo, ca
• Manufacturer Contact: eva manus ; 35 enterprise drive; aliso viejo, ca
• MDR Report Key: 10002289
• MDR Text Key: 189561995
• Report Number: 2032493-2020-00111
• Device Sequence Number: 1
• Product Code: QCA
• UDI-Device Identifier: 04987350998477
• UDI-Public: (01)04987350998477(11)181127(17)211031(10)18112753Z
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P170013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/01/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: MV-L251717
• Device Lot Number: 18112753Z
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/01/2020
• Initial Date FDA Received: 04/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/27/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Weight: 70