MAUDE Adverse Event Report: MICROVENTION, INC. FRED 27; FLOW DIVERTER

Model Number	FRED4017-PMA
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Thrombus (2101); Weakness (2145); Brain Injury (2219)
Date of Event	03/02/2020
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 not returned to the manufacturer for analysis.The root cause cannot be determined,.
Event or Problem Description
It was reported that treatment was performed for a left internal carotid artery (ica) terminus aneurysm.The fred was successfully placed at the treatment site without incident and immediate angiograms demonstrated a patent fred.After completion of the case, the patient experienced right sided weakness and speech difficulties, and was returned for another angiogram, which demonstrated an occluded fred.Thrombus was aspirated through an intermediate catheter and balloon angioplasty was performed within the fred, which restored vessel patency.Post-procedure images confirmed a patent left ica, left middle cerebral artery, and fred.The patient was reported to be nearly back to baseline neuro status on (b)(6) 2020.

• Brand Name: FRED 27
• Common Device Name: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo, ca
• MDR Report Key: 9914518
• Report Number: 2032493-2020-00081
• Device Sequence Number: 2377905
• Product Code: OUT
• UDI-Device Identifier: 00842429106730
• UDI-Public: (01)00842429106730(11)190306(17)220228(10)19030652WM
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P180027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/02/2020

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: Other
• Device Expiration Date: 02/28/2022
• Device Model Number: FRED4017-PMA
• Device Lot Number: 19030652WM
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2020
• Initial Report FDA Received Date: 04/01/2020
• 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: Required Intervention
• Patient Age: 76 YR