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

Model Number	FRED4528-PMA
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A search for non-conformance 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; therefore, the alleged product issue cannot be confirmed.
Event or Problem Description
Upon deployment of the fred device to treat a dissecting aneurysm (da) of an internal carotid artery, the device reportedly opened partially.A balloon catheter was deployed to successfully expand the stent to full opening.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 92656
• MDR Report Key: 10538420
• Report Number: 2032493-2020-00259
• Device Sequence Number: 2410502
• Product Code: OUT
• UDI-Device Identifier: 00842429106792
• UDI-Public: (01)00842429106792(11)200330(17)230228(10)20033057P
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P180027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/15/2020

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: FRED4528-PMA
• Device Lot Number: 20033057P
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2020
• Initial Report FDA Received Date: 09/15/2020
• 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