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

Model Number	FREDX5036-PMA
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	09/08/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that eight days post-implantation of a flow diverter, the patient presented to the er with stroke symptoms.Thrombosis was observed in the ica treatment site.Catheter aspiration was performed to treat the patient in order to address the symptoms.The physician determined that the patient did not take the prescribed plavix medication post-implantation of the flow diverter.The patient is in stable condition.
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.A medical image was provided.The investigation is currently ongoing.Once the investigation is completed, a supplemental report will be submitted.The instructions for use (ifu) identifies stroke and thrombus as a potential complications associated with the use of the device.
Additional Manufacturer Narrative
Manufacturer narrative: a single image is provided for the investigation; it is not labeled as to side or date.The image is a single lateral non-subtracted dsa image of an ica with contrast.A fred is seen, spanning from just above the pcom to the petrocavernous segment of the ica proximally.Coils are seen in a small pcom aneurysm; the pcom fills.The non-flow diverting segment of fred is distal to the pcom.The flow-diverting segment of the fred barely reaches the presumed location of the neck of the aneurysm, if at all.The aneurysm doesn't seem to fill, although it is difficult to evaluate on a non-subtracted image.The fred may be only partially opened just proximal to the posterior genu of the cavernous ica, but this is difficult to substantiate with only one projection.If the aneurysm that was being treated is the coiled pcom, the stent that was chosen is quite long.The physical device was not available for evaluation, so the investigation could not determine if a condition existed that would have caused or contributed to the reported event.

• 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: 15523941
• Report Number: 2032493-2022-00381
• Device Sequence Number: 16771017
• Product Code: OUT
• UDI-Device Identifier: 00842429114476
• UDI-Public: (01)00842429114476(11)210702(17)240630(10)0000180015
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/16/2022

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: FREDX5036-PMA
• Device Catalogue Number: FREDX5036
• Device Lot Number: 0000180015
• 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: 09/16/2022
• Supplement Date Received by Manufacturer: 10/12/2022
• Initial Report FDA Received Date: 10/01/2022
• Supplement Report FDA Received Date: 10/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/02/2021
• 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 Sex: Male