MAUDE Adverse Event Report: MICROVENTION, INC. FRED 21; FLOW DIVERTER

Model Number	FRED3021-PMA
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Extravasation (1842)
Date of Event	09/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A search for non-conformances associated with the reported 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; therefore, the alleged product issue cannot be confirmed.The instructions for use (ifu) identifies bleeding or hemorrhage (including intracerebral) and perforation or dissection of the vessel(s) as potential complications associated with use of the device.
Event or Problem Description
It was reported that during implantation of the fred jr, the distal end of the stent pulled back "into the deployment." contrast extravasation was observed.The fred was resheathed and removed, heparin was reversed, and the aneurysm was coiled.The extravasation was resolved.An evd was placed.Follow-up ct showed the brain was "normal," however, a tract hemorrhage was noted from the evd placement.
Additional Manufacturer Narrative
Additional information was provided that clarified the fred was placed to treat a 15mm aneurysm in the posterior communicating artery (pcom).The fred moved proximally due to backward force from the microcatheter halfway into the deployment.A patient status update indicated the patient has died due to hemorrhage from the evd placement, which was not related to the fred stent.

• Brand Name: FRED 21
• Common Device Name: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 10731620
• Report Number: 2032493-2020-00305
• Device Sequence Number: 13872938
• Product Code: OUT
• UDI-Device Identifier: 00842429106631
• UDI-Public: (01)00842429106631(11)200702(17)230630(10)200702563
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: P180027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2020

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: 06/30/2023
• Device Model Number: FRED3021-PMA
• Device Lot Number: 200702563
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/24/2020
• Supplement Date Received by Manufacturer: 11/18/2020
• Initial Report FDA Received Date: 10/23/2020
• Supplement Report FDA Received Date: 12/13/2020
• 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