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

Model Number UNKNOWN

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

Patient Problems Intracranial Hemorrhage (1891); Rupture (2208); Hydrocephalus (3272); Ruptured Aneurysm (4436)

Event Type  Injury  

Manufacturer Narrative

The device lot number was not provided; therefore, a device history record and non-conformance review could not be performed.The device was not returned to the manufacturer for analysis; therefore, the alleged product issue cannot be verified.The instructions for use (ifu) identifies aneurysm rupture and subarachnoid hemorrhage as potential complications associated with use of the device.Bibliography: endo, hideki, et al."long-term outcomes of y-stent-assisted coil embolization using low-profile visualized intraluminal support junior (lvis jr) for intracranial bifurcation aneurysms." clinical neurology and neurosurgery 217 (2022): 107275.

Event Description

As reported through the article titled, "long-term outcomes of y-stent-assisted coil embolization using low-profile visualized intraluminal support junior (lvis jr) for intracranial bifurcation aneurysms," a study compromising of twenty-one patients (22 aneurysms) that had been treated with y-stent-assisted coiling using lvis jr.Was performed.All procedures were performed successfully; however, it was reported that one patient suffered an intraoperative rupture and required treatment for subarachnoid hemorrhage and secondary hydrocephalus.The patient had a good recovery.

• 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; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 14518032
• MDR Text Key: 293257211
• Report Number: 2032493-2022-00212
• Device Sequence Number: 1
• Product Code: QCA
• Combination Product (y/n): Y
• Reporter Country Code: JA
• PMA/PMN Number: P170013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/09/2022
• 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
• Patient Outcome(s): Required Intervention