MAUDE Adverse Event Report: MICROVENTION, INC. FRED X27; FLOW DIVERTER

Model Number	FREDX3522-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); Transient Ischemic Attack (2109)
Date of Event	07/06/2022
Type of Reportable Event	Serious Injury
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 was implanted in the patient and is not available for return to the manufacturer for analysis.The instructions for use (ifu) identifies stroke or tia (transient ischemic attack) as potential complications associated with use of the device.
Event or Problem Description
It was reported that the fred device was used for treating a patient for left pcomm and anterior choroidal aneurysms.The pcomm measured 1.6x2.7x2.6 (neck 2.5) and the anterior choroidal measured 2.5x2x2 (neck 1.5).On the day of procedure the ica vessel measured proximal 3.03 and distal 3.2.Did not re-sheath during deployment.When patient woke up with transient right sided weakness, the dapt changed to brilenta.Patient experienced transient ischemic attack (tia) symptoms a couple hours after procedure (problem formed some clot in stent then) and was converted to ticagrelor (brilenta) where symptoms subsided.The patient was discharged the next day after procedure and reportedly came back that evening with a perforator stroke with decreased perfusion by mri.Ten days later, the patient returned with flow limiting clot in stent (stroke) and the physician utilized a stent retriever and aspiration to remove the fibrous clot.The next day ica vessel re-measurement was performed as proximal lat 2.9/3.2 and proximal ap 3.4 and distal 3.1.The patient is still in hospital with right sided arm and leg deficits.Rehab recommended.
Additional Manufacturer Narrative
Additional information: h6, h10 (summary of investigation).Summary of investigation: eight short avi format videos are provided (no still dsas, no measurements).They are short, subtracted roadmaps and unsubtracted fluoro captures that show catheterization of the left m1 with a headway 27, partial deployment of a fred x from the mid/proximal m1 to a point just above the described left small pcom, and anterior choroidal aneurysms.Then, a duo microcatheter is positioned into the pcom aneurysm with microguidewire guidance.The aneurysm is then coiled (medium packing); a short straight tail of the last coil may be slightly protruding into the ica.The fred is then completely deployed (covering the coil tail) with its proximal end just distal to the ophthalmic artery.Fred apposition appears satisfactory.The clotting is not visible in the provided imaging; the cause for the clotting complication and the neurological deficit is not seen on these videos.

• Brand Name: FRED X27
• Common Device Name: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise drive; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 15153882
• Report Number: 2032493-2022-00254
• Device Sequence Number: 14761025
• Product Code: OUT
• UDI-Device Identifier: 00842429114315
• UDI-Public: (01)00842429114315(11)211214(17)241130(10)0000134592
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P180027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2022

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: 11/30/2024
• Device Model Number: FREDX3522-PMA
• Device Catalogue Number: FREDX3522
• Device Lot Number: 0000134592
• 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: 07/19/2022
• Supplement Date Received by Manufacturer: 08/22/2022
• Initial Report FDA Received Date: 08/02/2022
• Supplement Report FDA Received Date: 08/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male