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

Model Number	FRED3014-PMA
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	12/15/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the fred jr stent did not fully open or oppose vessel wall in proximal part of the stent.The flared ends of proximal part of stent were open, but it was pinched down and not fully open after detachment.Clot formed 2 minutes after deployment, after the pusher was pulled out and the microcatheter was pulled back a little.Integrillin was given and patient will stay on integrillin for now.Patient was held at hospital for a few extra days for observation, then discharged and was doing "pretty well".Patient was brought back on january 6th for another angiogram and further treatment was not needed.
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 and procedure images not provided.Therefore, the alleged product issue cannot be confirmed.The instructions for use (ifu) identifies stent thrombosis as potential complications associated with use of the device.
Additional Manufacturer Narrative
Additional information received via user-facility medwatch # (b)(4) received from fda.Reference b5.
Event or Problem Description
Additional information received via user-facility medwatch # (b)(4) received from fda.Event described as: surgical procedure device malfunction.Adult male with past medical history of ruptured aneurysm due to successful coil embolization (b)(6) this year (2021).Presented for an elective cerebral angiogram with embolization.While attempting anterior communicating artery aneurysm flow divert, his embolization was complicated by stent malfunction.Stent did not fully open and is still in the vessel.Aneurysm remains.Patient stable, discharged to home after observation.Original intended procedure was cerebral angiography.

• Brand Name: FRED 21
• 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: 13232432
• Report Number: 2032493-2022-00016
• Device Sequence Number: 14529833
• Product Code: OUT
• UDI-Device Identifier: 00842429106624
• UDI-Public: (01)00842429106624(11)190507(17)220430(10)190507542M
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: FRED3014-PMA
• Device Lot Number: 190507542M
• 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: 12/15/2021
• Supplement Date Received by Manufacturer: 01/25/2022
• Initial Report FDA Received Date: 01/11/2022
• Supplement Report FDA Received Date: 02/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2019
• 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: 34 YR
• Patient Sex: Male
• Patient Weight: 76 KG