MAUDE Adverse Event Report: MICROVENTION, INC. FRED; FLOW DIVERTER

Model Number	FRED4038
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Aneurysm (1708); Visual Impairment (2138)
Date of Event	03/01/2021
Type of Reportable Event	Serious Injury
Additional 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 and not returned to the manufacturer for evaluation.Post procedural images were not provided.Therefore, the reported event could not be confirmed.
Event or Problem Description
As reported through a fred epi study, on (b)(6) 2021, a (b)(6) year old female patient received embolization treatment for a giant left cavernous carotid aneurysm, partly thrombosed, responsible for an orbital apex syndrome with oculomotor disorders and decreased visual acuity, in association with a compressive optic neuropathy.The patients symptoms begun approximately 18 months prior to the initial management, which was performed in (b)(6) 2020 by partial sealing of the aneurysm sac with multiple coils followed by additional embolization on (b)(6) 2021 by deployment of an fdv fred.Pre procedure neurological evaluation was mrs score 1.At the end of the treatment, the fdv fred fully covers the aneurysm neck.The post procedural angiographic result is a residual sac (riii) and the parent artery remains without stenosis.After treatment, the patient showed improvement in visual acuity and oculomotor disturbance.Patient discharged (b)(6) 2021.On (b)(6) 2021 (38days post procedure complication), the patient visual acuity and oculomotor disturbance worsened.On (b)(6) 2021, patient had a neuro ophthalmology consultation which revealed a worsening of the strabismus for which it was advised to occlude the left eye with a mask.A control mri was also performed on (b)(6) 2021 showing a persistence of circulation in the aneurysm sac.The study of the cerebral parenchyma did not show any ischemic lesion, notably recent or old.The question therefore arises on the management of this still permeable part of the aneurysm sac.According to the description provided by the site, the event is not serious.In terms of clinical impact, patient is symptomatic.The action taken in its regards is an ophthalmologic consultation and occlusion and the outcome is ongoing.The event relation is related to a study disease.The patient has a history of diabetes.Antiplatelet treatment of plavix 75 mg was administrated to the patient on (b)(6) 2021, and it is ongoing.Asa was also administrated on (b)(6) 2021 to (b)(6) 2021.

• Brand Name: FRED
• Common Device Name: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 12005447
• Report Number: 2032493-2021-00231
• Device Sequence Number: 3401635
• Product Code: OUT
• UDI-Device Identifier: 00811425021040
• UDI-Public: (01)00811425021040(11)190715(17)220630(10)19071555G
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P180027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/15/2021

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: 06/30/2022
• Device Model Number: FRED4038
• Device Catalogue Number: 140203HES-V
• Device Lot Number: 19071555G
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2021
• Initial Report FDA Received Date: 06/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 70 YR