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

Model Number	FREDX2518-PMA
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	03/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the procedure, the fred x21 stent was delivered without incident.Intra-stent thrombus was observed post delivery and was resolved with intra-arterial cangrelor and integrilin.There was no patient harm reported, who was reported to be doing well.
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; therefore, the alleged product issue cannot be confirmed.The instructions for use (ifu) identifies stent thrombosis as a potential complication associated with use of the device.
Additional Manufacturer Narrative
Additional information received indicating that no images are available.The device was placed in the aca as it was felt to be the best option for the patient.

• 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 drive; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 14003416
• Report Number: 2032493-2022-00134
• Device Sequence Number: 4432617
• Product Code: OUT
• UDI-Device Identifier: 00842429114223
• UDI-Public: (01)00842429114223(11)210401(17)240331(10)0000145805
• 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: 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): 03/14/2022

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: 03/31/2024
• Device Model Number: FREDX2518-PMA
• Device Catalogue Number: FREDX2518
• Device Lot Number: 0000145805
• 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: 03/14/2022
• Supplement Date Received by Manufacturer: 04/07/2022
• Initial Report FDA Received Date: 04/04/2022
• Supplement Report FDA Received Date: 04/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2021
• 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: Female