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

Model Number	FRED4513-PMA
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stroke/CVA (1770); Muscle Weakness/Atrophy (1967); Thrombosis/Thrombus (4440)
Date of Event	06/27/2021
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 returned to the manufacturer for evaluation.Post procedural images were not provided.Therefore, the reported event could not be confirmed.The instructions for use (ifu) identifies thrombus and stroke as potential complications associated with use of the device.
Event or Problem Description
It was reported that on (b)(6) 2021 a fred stent was successfully implanted to treat an aneurysm of ica without issue.On (b)(6) 2021, the patient returned to the hospital with stroke like symptoms and medical imaging showed that the stent had formed thrombus on it and had no flow.No adjunct treatment was attempted as it was past the 24-hour window.The patient has some left sided weakness.
Additional Manufacturer Narrative
Additional codes added to h6.Additional images were provided by the physician.The images provided could not confirm the complaint, the braids on the stent are visible on one slide; however, it cannot be determined if the device inner stent is opening to its full diameter on the proximal end (fish mouthing).To investigate further, a case simulation was performed with an analog vessel model.A sample fred4513 device was implanted in analog tortuous lica vessel with similar tortuosity.The analog vessel diameter in the proximal cavernous ica section is larger compared to the given case.Microdynact imaging of the implanted fred4513 sample confirmed no layer separation at the proximal end; the device opening was good despite vessel tortuosity.

• Brand Name: FRED 27
• Common Device Name: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 12292095
• Report Number: 2032493-2021-00313
• Device Sequence Number: 3636069
• Product Code: OUT
• UDI-Device Identifier: 00842429106778
• UDI-Public: (01)00842429106778(11)200730(17)230630(10)20073057G
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2021

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: FRED4513-PMA
• Device Lot Number: 20073057G
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/09/2021
• Supplement Date Received by Manufacturer: 09/16/2021
• Initial Report FDA Received Date: 08/08/2021
• Supplement Report FDA Received Date: 10/15/2021
• 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: Disability