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

Model Number LEV2512

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

Patient Problems Transient Ischemic Attack (2109); Visual Impairment (2138); Numbness (2415)

Event Date 08/14/2023

Event Type  Injury  

Manufacturer Narrative

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.The device was implanted in the patient; therefore, it will not be returned to the manufacturer for evaluation.Procedural or medical imaging was not provided; however, a medical report and discharge note were received.The alleged product issue could not be confirmed at this time.The investigation is ongoing.Upon completion, of the investigation, a supplemental report will be submitted.

Event Description

As reported through a sealant clinical trial, the patient was treated for a saccular bifurcation aneurysm on (b)(6) 2022 that is located on the middle anterior communicating artery (acom).The aneurysm never ruptured and was not previously treated.The treatment consisted of using a stent.Three coils were used during the procedure under the stenting post-coiling technique.The parent artery at the end of the procedure remains without stenosis.On (b)(6) 2022, the patient was discharged from the hospital with a neurological evaluation mrs score of 0, and nihss score of 1.On (b)(6) 2023, after 10 days of stopping clopidogrel, the patient developed numbness on the right half of the face, right arm, and a scotoma in the right eye.The symptoms lasted for 20 minutes.On the next day, dsa showed no in-stent stenosis or thrombus.The mri shows no acute ischemia.According to the description provided by the site, the event is not serious.In terms of clinical impact, the patient is asymptomatic.It is a neurological event (transient ischemic attack).It is not related to the device malfunction.The event is probably related to the lvis evo device and probably related to the study's disease condition.The event is not related to the coil study devices, not to the ancillary device and not to index endovascular procedure.It is also not related to concurrent disease conditions or treatment.The patient was prescribed clopidogrel for 6 months.The patient¿s outcome was resolved without sequelae on (b)(6) 2023.

Manufacturer Narrative

Correction: section h6 added clinical code: 2109 transient ischemic attack.A medical review of the provided procedure note was performed.The operative report data reviewed did not indicate that the lvis evo stent was associated with the reported ae (patient had 20 minutes of numbness of the right arm and the right side of the face) which occurred eight months post operatively and ten days after reported stoppage of clopidogrel.In addition, review of the operative report data did not indicate that there was a lvis evo device malfunction, and no device malfunction occurred which would have contributed to the reported ae.Data review further indicated that there was minimal intimal hyperplasia in the lvis evo stent, both stents were free-flowing with no evidence of in-stent stenosis or intimal hyperplasia which further indicates that the device was functional and there was no device malfunction that could be associated with the reported ae.A review of the discharge summary letter data indicated that the operative procedure was performed without reported complications.Further review of the discharge summary data indicated that when the patient was medically cleared for transition to post interventional monitoring ward, the patient experienced a mixed aphasia.Discharge summary data review did not indicate that a device malfunction occurred with the lvis evo device and did not indicate that the ae experienced by the patient was associated with the lvis evo device.Without the return and physical evaluation of the device, the investigation is unable to determine if a condition existed that would have caused or contributed to the reported event.

Event Description

See h10.

• 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: 17656474
• MDR Text Key: 322364901
• Report Number: 2032493-2023-00918
• Device Sequence Number: 1
• Product Code: QCA
• UDI-Device Identifier: 00842429103425
• UDI-Public: (01)00842429103425(11)220324(17)250228(10)0000171771
• 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: 08/16/2023

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: LEV2512
• Device Lot Number: 0000171771
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/30/2023
• Supplement Dates Manufacturer Received: 10/06/2023
• Supplement Dates FDA Received: 10/16/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/24/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female