MAUDE Adverse Event Report: MICROVENTION, INC. FRED X21; FLOW DIVERTER

Model Number	FREDX2513-PMA
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that upon a six month follow-up angiogram post deployment of a flow diverter, the device was completely occluded.The patient is asymptomatic and the vessel is backfilling from collaterals with complete obliteration of aneurysm.The patient is neurologically intact.No intervention will be performed.The patient initially presented with a m3 dissecting aneurysm.
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 device remains implanted in the patient and is therefore not available for return to the manufacturer for analysis.Two radiographic images were provided.Both are extremely coned-down dsas centered over the peripheral mca circulation.One shows a wide fusiform (described as mycotic in the report) m3 aneurysm (side and date not labeled on either image).The second image (presumably a follow-up) shows that the aneurysm and a short segment of the parent artery are occluded.It is likely that the small vessel diameter (1.27 and 1.7 mm) and the mycotic/infectious nature of the aneurysm contributed to the fred occlusion.The instructions for use (ifu) identifies stenosis of stented segment as a potential complication associated with the use of the device.

• Brand Name: FRED X21
• Common Device Name: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 15100048
• Report Number: 2032493-2022-00283
• Device Sequence Number: 17456771
• Product Code: OUT
• UDI-Device Identifier: 00842429114216
• UDI-Public: (01)00842429114216(11)210426(17)240331(10)0000127156
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: FREDX2513-PMA
• Device Catalogue Number: FREDX2513
• Device Lot Number: 0000127156
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2022
• Initial Report FDA Received Date: 07/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: .088 BLLAST; ASA/BRILINTA; HEADWAY 21; SOFIA EX
• Patient Age: 69 YR
• Patient Sex: Female