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

Model Number	172537-LVISJ-C-PMA
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	Ruptured Aneurysm (4436)
Date of Event	11/04/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
• Common Device Name: 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
• Report Number: 2032493-2021-00472
• Device Sequence Number: 5095254
• Product Code: NJE
• UDI-Device Identifier: 00842429100868
• UDI-Public: (01)00842429100868(11)210714(17)240630(10)21071452C
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P170013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/04/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2024
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2021
• Initial Report FDA Received Date: 12/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown