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

Model Number	FRED4513-PMA
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	Thrombus (2101)
Date of Event	03/04/2020
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 after the fred was deployed in the supraclinoid internal carotid artery (ica), imaging demonstrated occlusion of the ica.Thrombolytics were administered and the ica was revascularized.Dyna ct was performed and the fred did not appear to be fully opened around the tightest curvature of the ica.The patient awoke post anesthesia with no deficiencies or complications.The patient is currently reported to be in satisfactory condition.

• Brand Name: FRED 27
• Common Device Name: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo, ca
• MDR Report Key: 9919230
• Report Number: 2032493-2020-00082
• Device Sequence Number: 3296696
• Product Code: OUT
• UDI-Device Identifier: 00842429106778
• UDI-Public: (01)00842429106778(11)190312(17)220228(10)19031254GM
• 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): 03/04/2020

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?: Yes
• Operator of Device: Other
• Device Expiration Date: 02/28/2022
• Device Model Number: FRED4513-PMA
• Device Lot Number: 19031254GM
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2020
• Initial Report FDA Received Date: 04/02/2020
• 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