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

Model Number	FRED3507-PMA
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Neurological Deficit/Dysfunction (1982); Thrombus (2101)
Date of Event	07/17/2020
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 thus not returned to the manufacturer for evaluation.The root cause of the complaint cannot be determined.The instructions for use (ifu) identifies vessel occlusion, vessel stenosis or thrombosis, and neurologic deficits including stoke as potential complications associated with use of the device.
Event or Problem Description
It was reported that elective treatment was performed for an internal carotid artery (ica) aneurysm.The patient was on dapt (aspirin and brilinta).Deployment of the fred went well and the patient did well during the procedure.48 hours post-procedure, the patient had a stroke with severe hand weakness and mild arm weakness on the left.An angiogram was performed, which demonstrated an occlusion within the fred.Integrilin and tpa were delivered intra-arterially without effect; however, angiography showed there was good flow across the acom, filling the mca territory, so mechanical thrombectomy inside the stent was not attempted.The stent remains completely occluded.The patient has had slow improvement of the stroke symptoms, but there are still remaining deficits that are anticipated to get better over weeks with rehab and time.

• Brand Name: FRED 27
• Common Device Name: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo, ca
• MDR Report Key: 10411670
• Report Number: 2032493-2020-00210
• Device Sequence Number: 11312339
• Product Code: OUT
• UDI-Device Identifier: 00842429106655
• UDI-Public: (01)00842429106655(11)190513(17)220430(10)19051355WM
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P180027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/17/2020

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: 04/30/2022
• Device Model Number: FRED3507-PMA
• Device Lot Number: 19051355WM
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2020
• Initial Report FDA Received Date: 08/14/2020
• 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: Life Threatening; Required Intervention; Disability