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

Model Number FRED4038

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

Patient Problems Aneurysm (1708); Visual Impairment (2138)

Event Date 03/01/2021

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 and not returned to the manufacturer for evaluation.Post procedural images were not provided.Therefore, the reported event could not be confirmed.

Event 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
• Type of Device: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise drive; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 12005447
• MDR Text Key: 257749038
• Report Number: 2032493-2021-00231
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00811425021040
• UDI-Public: (01)00811425021040(11)190715(17)220630(10)19071555G
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P180027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2019
• 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: 70 YR