MAUDE Adverse Event Report: MICROVENTION, INC. FLOW RE-DIRECTION ENDOLUMINAL DEVICE (FRED)

Model Number	FRED3516-PMA
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Speech Disorder (4415); Thrombosis/Thrombus (4440)
Date of Event	04/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A search for non-conformances 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 implanted in the patient and not available for return to the manufacturer for analysis.The investigation is ongoing.
Event or Problem Description
It was reported that the procedure was a flow diversion of the right ica.The procedure was on label and proctored by the physician.The patient was on dapt therapy with a pru in optimal range measured just prior to procedure.The procedure was unremarkable with no peri-procedural complications.Several hours after procedure, the physician noticed patient abnormalities (mild expressive aphasia) during exam in post-operative icu.The patient was taken back to ir for intervention to perform angiography.Clot formation was noticed near the fred device during angiography, thrombectomy was attempted.In addition, the physician noticed the implanted fred device had experienced proximal foreshortening and/or slight distal migration.The physician attempted clot aspiration with no success.An attempt to cross the fred flow diverter with multiple devices with no success.The patient was treated with integrilin with a plan to switch patient from plavix / aspirin to brillinta / aspirin.Patient experienced mild expressive aphasia.
Additional Manufacturer Narrative
The device was not returned for evaluation; therefore, the product analysis could not be performed.The instructions for use (ifu) identifies device migration, vessel occlusion, vessel stenosis or thrombosis, and neurologicaldeficits including stroke and/or death as potential complications associated with use of the device.

• Brand Name: FLOW RE-DIRECTION ENDOLUMINAL DEVICE (FRED)
• Common Device Name: FRED
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 11828705
• Report Number: 2032493-2021-00211
• Device Sequence Number: 4444095
• 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
• 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): 06/11/2021

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: 05/31/2023
• Device Model Number: FRED3516-PMA
• Device Lot Number: 20061755J
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/15/2021
• Supplement Date Received by Manufacturer: 05/14/2021
• Initial Report FDA Received Date: 05/14/2021
• Supplement Report FDA Received Date: 06/11/2021
• 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: 45 YR