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

Model Number	FRED4508
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)
Date of Event	03/23/2021
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 implanted in the patient and not returned to the manufacturer for analysis.Additionally, procedural images were not provided; therefore, the reported event cannot be confirmed.The instructions for use identifies in-stent thrombosis as a potential complication associated with use of the device.
Event or Problem Description
It was reported that a fred 4508 stent was deployed to treat an internal carotid artery (ica) aneurysm.The patient was pretreated with a regimen of aspirin and clopidogrel starting five days prior to treatment.After deployment and detachment, the fred4508 stent foreshortened distally and the aneurysm was not completely covered.It was decided to use a second fred stent to cover the distal part of the aneurysm.During insertion of the microcatheter, the patient showed an ica occlusion and intravenous integrilin was administered.After a few minutes, all vessels were open and a remodeling balloon was used inside of the first fred 4508 stent.During the inflation of the balloon, an incomplete opening in the curve was visible.The second fred stent was then deployed.Dyna-ct at the end showed no vessel occlusions.

• Brand Name: FRED
• Common Device Name: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 11713674
• Report Number: 2032493-2021-00151
• Device Sequence Number: 3591017
• Product Code: OUT
• UDI-Device Identifier: 00811425021057
• UDI-Public: (01)00811425021057(11)190115(17)211231(10)19011552A
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P180027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/22/2021

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: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: FRED4508
• Device Catalogue Number: 140205HES-V
• Device Lot Number: 19011552A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2021
• Initial Report FDA Received Date: 04/23/2021
• 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