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

Model Number	FRED3516-PMA
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	12/02/2020
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 delivery pusher and microcatheter were returned; however, the stent was not returned for evaluation.Fluoroscopic images were provided for review, which confirmed the presence of thrombus within the stent and an occlusion of the mca, as reported.There is no obvious indication of deformity of the stent construct or incomplete expansion of the stent in the limited images provided.The instructions for use identifies stent thrombosis and thromboembolic event as potential complications associated with use of the device.
Event or Problem Description
It was reported that after deployment of the fred device in the internal carotid artery (ica), thrombus developed within the stent and the middle cerebral artery (mca) became occluded.Heparin was increased and tpa was administered, which improved flow in the mca.The fred device was successfully retrieved from the patient.There was no reported sequela.
Additional Manufacturer Narrative
Patient status update was provided, which indicated the patient has remained stable and there has been no exacerbation of the patient's symptoms/condition.

• Brand Name: FRED 27
• Common Device Name: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 11061543
• Report Number: 2032493-2020-00389
• Device Sequence Number: 2691629
• Product Code: OUT
• UDI-Device Identifier: 00842429106679
• UDI-Public: (01)00842429106679(11)200617(17)230531(10)20061755J
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P180027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2021

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: Other
• Device Expiration Date: 05/31/2023
• Device Model Number: FRED3516-PMA
• Device Lot Number: 20061755J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2020
• Initial Date Received by Manufacturer: 12/02/2020
• Supplement Date Received by Manufacturer: 01/07/2021
• Initial Report FDA Received Date: 12/22/2020
• Supplement Report FDA Received Date: 02/06/2021
• 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: 62 YR