MAUDE Adverse Event Report: MICROVENTION, INC. LVIS EVO; INTRACRANIAL COIL-ASSIST STENT

Model Number LEV2527-MVE

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

Patient Problems Speech Disorder (4415); Ischemia Stroke (4418); Thrombosis/Thrombus (4440)

Event Date 01/23/2023

Event Type  Injury  

Event Description

As reported through the sealant clinical study, the patient was treated for a 6.5 x 4.7 x 3.4 saccular bifurcation aneurysm, located on the left middle cerebral artery (mca).The aneurysm never ruptured and was not previously treated.During the embolization and due to high friction inside catheter, the first lvis evo stent attempted was not implanted and was removed without problems.A second lvis evo was exchanged and successfully implanted together with a web sl intrasaccular device and an hydrosoft coil by jailed-catheter technique.At the end of the procedure, the parent artery remained without stenosis.The patient was discharged from the hospital with a neurological evaluation mrs score 0.Reportedly, 7 months post embolization procedure, in stent stenosis developed at superior trunk and the patient experienced ischemic stroke with a nihss score 0, located in the ipsilateral side.The outcome described as "not resolved/ongoing." patient is scheduled for a mri and angiography follow-up exam in two months.

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 implanted in the patient and not available for return; however, procedure images were provided and their review is not complete.The instructions for use (ifu) identifies neurologic insufficiencies including stroke as a potential complication associated with use of the device.

Manufacturer Narrative

Visual analysis: a visual inspection of the device captured in this file could not be performed as a physical device was not returned for evaluation.Investigation findings: without the return and physical evaluation of the device, the investigation cannot definitively determine if a condition existed that would have caused or contributed to the reported event.Based on a review of the device¿s risk documentation, the reported event did not indicate there were any potential or new manufacturing, design, quality, or other systemic issues, or non-conformances.The complaint code is monitored through the trending process; corrective action is determined, as needed, through this process.Investigations of historic complaint files with similar complaint category coding are recorded in the complaint handling system; without the ability to perform and analysis of the device, this investigation cannot identify with certainty any potential root causes.Batch review: a search for non-conformances 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.Complaint system review: there are no similar complaints based on the complaint category regarding this batch number from the last two years recorded in the complaint system at the time of this investigation.Ifu review (additional information can be found in the ifu, following is taken from the english version): potential complications: possible complications include but are not limited to the following: hematoma at the puncture site, perforation or dissection of the vessel(s), intravascular spasm, hemorrhaging, rupture or perforation of aneurysm, coil herniation, device migration, neurologic insufficiencies including stroke and death, ischemia, vascular occlusion, vessel stenosis, incomplete aneurysm occlusion, pseudoaneurysm formation, distal embolization, headache, infection, reaction to contrast agents including severe allergic reactions and renal failure.Imaging review: two sets of dicom images were provided.The first set was obtained on the day of the procedure.Multiple flat plate cts show an lvis evo spanning from the superior division of the left m2 to the proximal left m1.A 3d dsa demonstrates an approximately 6 mm mca bifurcation aneurysm containing a web and a coil; an lvis evo spans from the proximal m1 to the superior division of the left m2.The resolution is such that i cannot comment on the presence or absence of stenosis.The m1 and m2 are patent.There are no procedural images.The second set was obtained on the follow-up examination on the event date.There are dsas of the left ica in ap, lateral, and one oblique projection.The aneurysm is completely occluded.The superior m2 division of the left mca where the lvis evo is located is severely diffusely narrowed.There is a severe stenosis at the origin of the inferior left mca m2 division.A 3d dsa shows the same.These images do not explain the friction problem the operator experienced with the lvis evo, nor the stenosis that are observed on the 6-month follow-up.

• Brand Name: LVIS EVO
• Type of Device: INTRACRANIAL COIL-ASSIST 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: 16354849
• MDR Text Key: 309307087
• Report Number: 2032493-2023-00563
• Device Sequence Number: 1
• Product Code: QCA
• UDI-Device Identifier: 00842429103456
• UDI-Public: (01)00842429103456(11)201123(17)231031(10)20112354Y
• 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: Foreign,Study,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/26/2023

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 Expiration Date: 10/31/2023
• Device Model Number: LEV2527-MVE
• Device Lot Number: 20112354Y
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/26/2023
• Initial Date FDA Received: 02/10/2023
• Supplement Dates Manufacturer Received: 02/16/2023
• Supplement Dates FDA Received: 03/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2020
• 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
• Patient Age: 71 YR
• Patient Sex: Female