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	Thrombus (2101)
Date of Event	07/13/2020
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 investigation.The root cause cannot be determined.The instructions for use (ifu) identifies vessel occlusion and vessel stenosis or thrombosis as potential complications associated with use of the device.
Event or Problem Description
It was reported that after deployment of the fred, the flow diverter was not completely apposed around the syphon in two locations and thrombus developed.A microwire was used to encourage stent apposition; however, the stent foreshortened after the manipulations with the wire, and thrombus formed within the proximal portion of the fred where the working length begins and outside the stent in the areas of malapposition.Integrilin was delivered to the patient and the thrombus resolved in all locations except at the proximal portion of the device where ct images suggest the stent is bunched along the horizontal cavernous segment.All other vessels were patent, post-procedure.The patient moved all extremities after waking from anesthesia.The patient is reported to be clinically stable and neurologically intact with no sequela.

• Brand Name: FRED 27
• Common Device Name: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo, ca
• MDR Report Key: 10405015
• Report Number: 2032493-2020-00200
• Device Sequence Number: 3859982
• Product Code: OUT
• UDI-Device Identifier: 00842429106792
• UDI-Public: (01)00842429106792(11)191209(17)221130(10)19120953GM
• 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): 07/13/2020

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: 11/30/2022
• Device Model Number: FRED4528-PMA
• Device Lot Number: 19120953GM
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2020
• Initial Report FDA Received Date: 08/13/2020
• 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
• Patient Age: 52 YR