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

Model Number FRED3516-PMA

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 12/02/2020

Event Type  Injury  

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 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.

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
• Type of Device: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 11061543
• MDR Text Key: 223380423
• Report Number: 2032493-2020-00389
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00842429106679
• UDI-Public: (01)00842429106679(11)200617(17)230531(10)20061755J
• Combination Product (y/n): N
• PMA/PMN Number: P180027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 01/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR