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

Model Number	FRED5029-PMA
Medical Device Problem Codes	Difficult to Remove (1528); Malposition of Device (2616)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/22/2020
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 evaluation.The root cause of the complaint cannot be determined.
Event or Problem Description
It was reported that treatment was attempted for an internal carotid artery aneurysm.The patient's anatomy was reported to be very tortuous.The proximal finished ends of the fred were deployed at the neck of the aneurysm.An attempt was made to re-access the proximal end of the device with a microcatheter and the fred was pushed into the aneurysm sac.Multiple attempts were then made to remove the fred using a guide wire and a snare device, including accessing the contralateral femoral artery to reach the fred through the acom artery.All attempts were unsuccessful and the fred was left implanted in the aneurysm.There was no reported patient injury.

• Brand Name: FRED 27
• Common Device Name: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo, ca
• MDR Report Key: 10311955
• Report Number: 2032493-2020-00173
• Device Sequence Number: 16412559
• Product Code: OUT
• UDI-Device Identifier: 00842429106846
• UDI-Public: (01)00842429106846(11)200311(17)230228(10)20031155A
• 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): 06/22/2020

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: 02/28/2023
• Device Model Number: FRED5029-PMA
• Device Lot Number: 20031155A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2020
• Initial Report FDA Received Date: 07/22/2020
• 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: 69 YR