MAUDE Adverse Event Report: MICROVENTION, INC. LVIS EVO 4.0X21MM; INTRALUMINAL SUPPORT DEVICE

Model Number LEV4021-MVE

Device Problems Difficult to Remove (1528); Difficult to Open or Close (2921)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/11/2022

Event Type  malfunction  

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; therefore, the alleged product issue cannot be verified.

Event Description

During the stent assisted re-treatment of a recurrent giant aneurysm with an outgoing a choroidea anterior, an attempt was made to cross a previously implanted lvis evo device, however, the proximal portion of the stent did not open.The physician made an attempt to retrieve the stent; however, was unsuccessful, and remained implanted in the patient partially open.The patient is reported to be in good condition.

• Brand Name: LVIS EVO 4.0X21MM
• Type of Device: INTRALUMINAL SUPPORT DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 14516760
• MDR Text Key: 293285762
• Report Number: 2032493-2022-00211
• Device Sequence Number: 1
• Product Code: QCA
• UDI-Device Identifier: 00842429103562
• UDI-Public: (01)00842429103562(11)201109(17)231031(10)20110954Z
• Combination Product (y/n): Y
• 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: 05/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: LEV4021-MVE
• Device Lot Number: 20110954Z
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/12/2022
• Initial Date FDA Received: 05/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2017
• 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