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

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

Patient Problems Muscle Weakness (1967); Stenosis (2263); Thrombosis/Thrombus (4440)

Event Type  Injury  

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 the delivery system was not returned to the manufacturer for analysis; therefore, the alleged product issue cannot be confirmed.The instructions for use (ifu) identifies stent thrombosis as potential complications associated with use of the device.

Event Description

As reported through the article titled, "endovascular treatment of symptomatic intracranial atherosclerotic stenosis with low profile visualized intraluminal support stent", three hours post implantation of an lvis stent for the treatment of intracranial atherosclerotic stenosis, one patient suffered from ischemic complication and timely delivery of rt-pa successfully recanalized the artery.Fifteen minutes later, the in-stent thrombus disappeared and patient muscle strength level recovered to grade 4 with clear speech.The patient had been diagnosed with 90% stenosis in right m1 artery, after deployment of 3.5/15 mm lvis stent, the residual stenosis was 30%.

• Brand Name: LVIS
• 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: 12310346
• MDR Text Key: 266163740
• Report Number: 2032493-2021-00321
• Device Sequence Number: 1
• Product Code: QCA
• 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: 07/12/2021

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/12/2021
• Initial Date FDA Received: 08/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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