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

Model Number 172537-LVISJ-C-PMA

Device Problem Activation Problem (4042)

Patient Problem Ruptured Aneurysm (4436)

Event Date 11/04/2021

Event Type  malfunction  

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.Images were not provided.The alleged product issue could not be confirmed.The instructions for use (ifu) lists rupture or perforation of aneurysm as a potential complication associated with use of the device.

Event Description

It was reported that an lvis jr.Stent was used to treat a basilar tip aneurysm after it was coiled.The distal tines of the stent did not open and a balloon was used to open them.During the second inflation attempt, the aneurysm ruptured.The stent was left implanted.

• Brand Name: LVIS JR.
• 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: 12929808
• MDR Text Key: 287125686
• Report Number: 2032493-2021-00472
• Device Sequence Number: 1
• Product Code: NJE
• UDI-Device Identifier: 00842429100868
• UDI-Public: (01)00842429100868(11)210714(17)240630(10)21071452C
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P170013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 172537-LVISJ-C-PMA
• Device Catalogue Number: 172537-LVISJ
• Device Lot Number: 21071452C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2021
• 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