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

Model Number UNKNOWN

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

Patient Problems Paresis (1998); Thromboembolism (2654)

Event Type  Injury  

Event Description

As reported through the article titled, "a single flow re-direction endoluminal device for the treatment of large and giant anterior circulation intracranial aneurysms" published in yonsei medical journal, a patient that was treated with a fred for an unruptured aneurysm (diameter 17.7mm x neck size 6.4mm) at the ica (internal carotid artery) between january 2018 and july 2020 experienced a thromboembolic complication (hemiparesis) on postoperative day 0.The patient recovered without neurological deficit.The patient was a responder to : aspirin and clopidogrel.

Manufacturer Narrative

The lot number was not provided; therefore, a search for production-related ncrs could not be performed.The device was implanted in the patient and was not available for return to the manufacturer for analysis.Medical imaging was not available.Therefore, the reported event could not be confirmed.The instructions for use (ifu) identifies thromboembolic event as a potential complication associated with use of the device.Choi, jai ho, et al."a single flow re-direction endoluminal device for the treatment of large and giant anterior circulation intracranial aneurysms." yonsei medical journal 63.4 (2022): 349.

• 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: 14150218
• MDR Text Key: 290305767
• Report Number: 2032493-2022-00161
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P180027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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