MAUDE Adverse Event Report: MICROVENTION, INC. LVIS HDE; INTRACRANIAL NEUROVASCULAR STENT

Model Number	214035-LVIS-D-HDE
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Ruptured Aneurysm (4436)
Date of Event	08/01/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported through the lvis pas clinical study: target aneurysm rupture and retreatment: left carotid cavernous fistula from left inferior petrosal sinus with complete obliteration of the left cavernous ica aneurysm, visit to the emergency room complaining of the worst headache of her life.Target cavernous aneurysm treated with stent only, goes on to rupture with development of ccf and undergoes transvenous treatment.The severity of the event was a grade 3.Adverse event not associated with a neurological deficit.The event location was ipsilateral to target lesion.The event was not a transient ischemic attach (tia) or stroke, target aneurysm rebled.The index procedure was performed seven and a half months prior.The event was resolved without sequelae.The event was adjudicated to be related to the study device, study procedure, and disease.
Additional Manufacturer Narrative
Note: the product code in section d should be "nje", however, that is not an available option.Thus, "qca" was chosen as it was the closest match.The physical device was not available for evaluation to investigate if a condition existed that would have contributed to the reported event.Supplemental imaging was also unavailable for review; without imaging, the investigation cannot verify the event occurred as described, nor could the investigation further examine the cause of the reported event.This information may be updated if additional information is provided at a later date.This study is ongoing and device/procedure relatedness determinations can be re-adjudicated by independent reviewers/physicians.The study device and study procedure relatedness can change as a result of these reviews.Microvention is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by microvention, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Microvention has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, microvention, or its employees that the device, microvention, or its employees caused or contributed to the event described in the report.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.

• Brand Name: LVIS HDE
• Common Device Name: INTRACRANIAL NEUROVASCULAR 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: 22066997
• Report Number: 2032493-2025-90174
• Device Sequence Number: 9501680
• Product Code: QCA
• UDI-Device Identifier: 00812636022239
• UDI-Public: (01)00812636022239(11)170616(17)200531(10)17061654U
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: H130005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/21/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2020
• Device Model Number: 214035-LVIS-D-HDE
• Device Lot Number: 17061654U
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2025
• Initial Report FDA Received Date: 05/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/16/2017
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White