MAUDE Adverse Event Report: MICROVENTION, INC. FRED 21; FLOW DIVERTER

Model Number	FRED2508-PMA
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	03/25/2021
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 not returned to the manufacturer for analysis.Additionally, procedural images were not provided; therefore, the reported event cannot be confirmed.The instructions for use identifies in-stent thrombosis as a potential complication associated with use of the device.
Event or Problem Description
It was reported that a patient presenting with a ruptured blister aneurysm of the distal anterior cerebral artery was treated with a fred 21 flow diverter stent.The fred 21 was deployed without issue and immediate angiography showed no issues.On the third post-deployment angiogram at the 15-minute mark, a small amount of thrombus began to display on the fred 21's distal finished ends between the distal-most marker and flow diverting portion.A full body weight dose of eptifibatide was given, which instantly resolved the thrombus formation.Serial angiograms were again performed for 30 minutes afterward, which showed no additional thrombus formation.No further issues were observed, and no patient harm was reported.
Additional Manufacturer Narrative
H11 - corrections.

• Brand Name: FRED 21
• Common Device Name: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 11721264
• Report Number: 2032493-2021-00156
• Device Sequence Number: 3591019
• Product Code: OUT
• UDI-Device Identifier: 00842429106570
• UDI-Public: (01)00842429106570(11)200113(17)221231(10)20011356VM
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P180027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2021

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: 12/31/2022
• Device Model Number: FRED2508-PMA
• Device Lot Number: 20011356VM
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/25/2021
• Supplement Date Received by Manufacturer: 06/25/2021
• Initial Report FDA Received Date: 04/23/2021
• Supplement Report FDA Received Date: 06/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention