MAUDE Adverse Event Report: MICROVENTION INC. LVIS D; INTRACRANIAL COIL-ASSIST STENT

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

Patient Problem Aneurysm (1708)

Event Date 04/13/2022

Event Type  Injury  

Event Description

It was reported that 19 days post deployment of two lvis stents for the treatment of a ruptured aneurysm in the internal carotid artery, the aneurysm became slightly enlarged and the patient had to be retreated with an additional lvis blue stent.During removal of the delivery wire, however, it became caught in the area where the stent was implanted.The physician was able to remove the wire by raising the microcatheter and applying force.After detachment, the cone-beam ct revealed that the tip of the delivery wire had most likely broken off and remained in the patient.An additional lvis blue stent was implanted from c1 to c4 to affix the tip of the wire to the vessel wall.The procedure was successfully completed and the patient condition was reported as "non-serious health damage".

Manufacturer Narrative

It is unknown which of the two lvis stents that were initially implanted contributed to the aneurysm recurrence, therefore the information pertaining to both devices is being provided.Reference the following information: brand name: part number: lot number: manufacture date: expiration date: udi number: lvis d mv-l402221 19112555n 11/25/2019 oct 31, 2022 (b)(4).Lvis d mv-l401721 19091054a 09/10/2019 aug 31, 2022 (b)(4).The non-coformance search was performed for both lot numbers.The results are stated as follows: a search for non-conformance's associated with this part/lot number combinations did not reveal any production-related issues relevant to the complaints that occurred during manufacturing of the devices.The two devices remain implanted in the patient.Therefore, they are not available to be returned to the manufacturer; therefore, the reported issue cannot be confirmed.Reference related report# 2032493-2022-00169.

• Brand Name: LVIS D
• Type of Device: INTRACRANIAL COIL-ASSIST STENT
• 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: 14594211
• MDR Text Key: 293285342
• Report Number: 2032493-2022-00171
• Device Sequence Number: 1
• Product Code: QCA
• 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: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2022
• 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
• Treatment: HEADWAY 21
• Patient Outcome(s): Required Intervention