MAUDE Adverse Event Report: MICROVENTION, INC. LVIS EVO; INTRALUMINAL DEVICES

Model Number LEV3024-MVE

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

Patient Problem Ischemia Stroke (4418)

Event Date 10/10/2023

Event Type  Injury  

Event Description

As reported through the sealant study, the patient was treated for a saccular bifurcation aneurysm, located on the right middle cerebral artery (mca).The aneurysm never ruptured and not previously treated.The treatment consisted of using a stent lvis evo, embolization coils were used under jailed-catheter technique.The parent artery at the end of the procedure remains without stenosis.The patient discharged from the hospital with a neurological evaluation; mrs 0, nihss 0.Post procedure, 6 months following treatment, the patient was disoriented for about an hour while walking outside.The event is reported not serious.In term of clinical impact, the patient is asymptomatic.It is a neurological event (ischemic stroke), it is not associated with device malfunction.The event is possibly related to the lvis evo device.It is not related to the hydrocoils study device, not to the ancillary device and not to the index endovascular procedure.The event is also not related to the study disease condition and not related to concurrent disease condition or treatment.No action taken for this ae.The outcome is resolved without sequelae on (b)(6) 2023.The neurological evaluation of the patient on (b)(6) 2023 is mrs score 0, nhiss 0.Ae1: patient not locally oriented for 1 hour.Ischemic stroke.The event occurred during walking with the patient's dog in the forest.Based on the information provided, the reported ischemic stroke is indicated as possible relation to the study device, lvis evo.Medical history: smoking, systemic hypertension, hyperlipidemia, pituitary adenoma.Neurological history: none.Pre procedure neurological evaluation: mrs score 0 - nihss score 0.Antiplatelet therapy & other treatments: the antiplatelet test resistance was performed, and the patient showed no resistance.Aspirin 100mg.Plavix 75mg.

Manufacturer Narrative

A search for non-conformances associated with the reported part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device remains within the patient; therefore, the alleged product issue cannot be confirmed.If the device or additional information is received, microvention, inc., will submit a supplemental report.The instructions for use (ifu) identifies ischemic stroke as potential complications associated with use of the device.

• Brand Name: LVIS EVO
• Type of Device: INTRALUMINAL DEVICES
• 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: 18179132
• MDR Text Key: 328615234
• Report Number: 2032493-2023-01064
• Device Sequence Number: 1
• Product Code: QCA
• UDI-Device Identifier: 00842429103470
• UDI-Public: (01)00842429103470(11)221220(17)251130(10)0000298430
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P170013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/20/2023

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
• Device Operator: Health Professional
• Device Model Number: LEV3024-MVE
• Device Lot Number: 0000298430
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/08/2023
• Initial Date FDA Received: 11/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2023
• 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): Other
• Patient Age: 64 YR
• Patient Sex: Male