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

Model Number 212517-CAS-D-CN

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

Patient Problems Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)

Event Date 10/15/2020

Event Type  Injury  

Manufacturer Narrative

A search for non-conformances associated with the reported 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 evaluation.Intraprocedural or post-procedural images were not provided for review; therefore, the reported event cannot be confirmed.The instructions for use identifies stent thrombosis as a potential complication associated with use of the device.This device was used during the same procedure as the devices referenced in mfr.Reports # 2032493-2020-00334 and 2032493-2020-00337.

Event Description

It was reported that coil embolization was performed to treat a ruptured pcom, an acom aneurysm, and an anterior choroidal artery aneurysm.Lvis stents were implanted in the acom and the pcom.During deployment of the coil in the pcom, the surgeon had difficulty detaching the coil, and it stretched during the attempted removal.The internal carotid artery (ica) became occluded and thrombus developed in the lvis stents.The ica occlusion and in-stent thromboses were treated with thrombolytic medication.There was no suspected device malfunction.The patient was reported to be in a coma at the time of this event notification.It is unknown if the device was related to the patient's current condition.

• Brand Name: LVIS D
• Type of Device: INTRALUMINAL SUPPORT DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• Manufacturer Contact: eva manus ; 35 enterprise drive; aliso viejo, CA 92656
• MDR Report Key: 10954217
• MDR Text Key: 219884320
• Report Number: 2032493-2020-00329
• Device Sequence Number: 1
• Product Code: QCA
• UDI-Device Identifier: 00812636020075
• UDI-Public: (01)00812636020075(11)200121(17)221231(10)20012155P
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 12/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 12/31/2022
• Device Model Number: 212517-CAS-D-CN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/12/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2020
• 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): Hospitalization; Required Intervention; Disability