• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services


  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

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.
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameFRED
Manufacturer (Section D)
35 enterprise
aliso viejo CA 92656
Manufacturer Contact
terrence callahan
35 enterprise drive
aliso viejo, CA 92656
MDR Report Key12005447
MDR Text Key257749038
Report Number2032493-2021-00231
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
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 Received06/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/30/2022
Device Model NumberFRED4038
Device Catalogue Number140203HES-V
Device Lot Number19071555G
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/19/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/15/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 06/15/2021 Patient Sequence Number: 1