MAUDE Adverse Event Report: MICROVENTION, INC. LVIS EVO; INTRALUMINAL SUPPORT DEVICE

Model Number LEV4021-MVE

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

Patient Problem Thrombosis/Thrombus (4440)

Event Date 07/07/2021

Event Type  Injury  

Event Description

It was reported that an aneurysm treated with a web device approximately six months ago had recanalized.An lvis evo stent was implanted to treat the aneurysm; it opened well and shouldered well at the neck.Attempts to implant additional coils were unsuccessful.It was then noticed that the web had shifted in its position due to the implantation of the lvis and was compressing the left posterior, which ceased to be visible under fluoroscopy.The physician administered aggrastat and the posterior circulation again became visible.After the procedure, an update to the patient's status was received; "the patient is still well off, the vessels of the posterior circulation were open, and the patient is free of symptoms." this device was used during the same procedure as the device referenced in mfr.Report # 2032493-2021-00072.

Manufacturer Narrative

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 device was implanted in the patient and not returned to the manufacturer for analysis.Medical imaging was not provided.The event could not be confirmed.At the time this complaint was received, this product was an exported device that was not cleared or approved for marketing in the u.S.The complaint is being reported now as based on this product meeting similar product criteria.The instructions for use (ifu) identifies in-stent thrombosis as a potential complication associated with use of the device.

• Brand Name: LVIS EVO
• Type of Device: INTRALUMINAL SUPPORT DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise drive; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 13595486
• MDR Text Key: 288190095
• Report Number: 2032493-2022-00071
• Device Sequence Number: 1
• Product Code: NJE
• UDI-Device Identifier: 00842429103562
• UDI-Public: (01)00842429103562(11)200421(17)230331(10)200421556
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P170013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/07/2021

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: 05/31/2023
• Device Model Number: LEV4021-MVE
• Device Lot Number: 200421556
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/26/2022
• Initial Date FDA Received: 02/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/21/2020
• 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 Sex: Female