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

Model Number	FRED4007-PMA
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	11/10/2021
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 not returned to the manufacturer for evaluation.Two angiographic images were provided.The first shows a lateral subtracted ica dsa, arterial phase, which appears to be taken immediately post fred implantation, showing good flow through fred and distally.The fred is positioned adequately across the ophthalmic aneurysm neck.The proximal markers are at the anterior genu of the cavernous ica; the distal markers are just below the anterior choroidal artery.The proximal and distal markers are visible and seem to be fully opened.No comment can be made on the braided portion, which is obscured by contrast material.The second image (6 month follow-up) is of poor quality but shows the lateral ica dsa, labeled 6 month follow up.There is some slow flow through the diminutive cavernous and supraclinoid artery, minimal aneurysm neck remnant, flow stops at the level of the anterior choroidal, which is faintly opacified.The stent markers cannot be seen on this image, so the exact stent positioning cannot be identified.Without the return and physical evaluation of the device, the investigation is unable to determine if a condition existed that would have caused or contributed to the reported event.The instructions for use (ifu) identifies in-stent thrombosis as a potential complication associated with use of the device.
Event or Problem Description
It was reported that a fred 27 stent was implanted in the patient without issue.The patient was placed on dual antiplatelet therapy and did respond to it.At the six month follow up, the lumen of the fred had closed off due to thrombus.There are no patient health deficits and no intervention is planned.There was cross-fill through the acom artery.

• Brand Name: FRED 27
• Common Device Name: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise drive; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 12972455
• Report Number: 2032493-2021-00482
• Device Sequence Number: 4395099
• Product Code: OUT
• UDI-Device Identifier: 00842429106709
• UDI-Public: (01)00842429106709(11)200902(17)230630(10)20072255Z
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/11/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: FRED4007-PMA
• Device Lot Number: 20072255Z
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2021
• Initial Report FDA Received Date: 12/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR
• Patient Sex: Female