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

Model Number	FREDX5021-PMA
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Nervous System Problem (4426)
Date of Event	06/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the same day, after placement of a flow diverter, the patient experienced neurological changes; therefore, a bolus of medication was provided and the symptoms resolved with no further treatment.Treatment site was right pcom.During placement of the flow diverter, it was noted that it was difficult to open the device around curves and that the device was falling back or migrating proximally.The distal landing zone was changed to proximal m1.The flow diverter was implanted.Ct exam was performed after symptoms appeared and an initial diagnosis of "partial thrombosis of the distal stent" was made.Upon the patient's return to the angiosuite, thrombosis was not observed and no further treatment was required.Cyna ct was performed eight days post-treatment and before discharge, which showed no issues.The patient is reported as good.
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.Additionally, the procedural images were not made available for review.On this basis, the event as described could not be confirmed.The instructions for use (ifu) identifies neurological deficits as a potential complication associated with use of the device.

• 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; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 14781204
• Report Number: 2032493-2022-00241
• Device Sequence Number: 14714886
• Product Code: OUT
• UDI-Device Identifier: 00842429114452
• UDI-Public: (01)00842429114452(11)210716(17)240630(10)0000146220
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/06/2022

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: 06/30/2024
• Device Model Number: FREDX5021-PMA
• Device Catalogue Number: FREDX5021
• Device Lot Number: 0000146220
• 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: 06/06/2022
• Initial Report FDA Received Date: 06/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/16/2021
• 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: COOK SHUTTLE 6 FR; HEADWAY 27 MICROCATHETER; SOFIA 6FR 115CM; SYNCHRO GUIDE WIRE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female