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

Model Number FRED4528-PMA

Device Problem Activation Failure (3270)

Patient Problem Thrombus (2101)

Event Date 07/13/2020

Event Type  Injury  

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 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
• Type of Device: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo, ca
• Manufacturer Contact: eva manus ; 35 enterprise drive; aliso viejo, ca
• MDR Report Key: 10405015
• MDR Text Key: 202894777
• Report Number: 2032493-2020-00200
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00842429106792
• UDI-Public: (01)00842429106792(11)191209(17)221130(10)19120953GM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P180027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2022
• Device Model Number: FRED4528-PMA
• Device Lot Number: 19120953GM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR