MAUDE Adverse Event Report: MICROVENTION, INC. FRED 27; FLOW DIVERTER

Model Number	FRED4026-PMA
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Codes	Stroke/CVA (1770); Thrombosis/Thrombus (4440)
Date of Event	02/25/2021
Type of Reportable Event	Death
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 or post-procedural images were not provided; therefore, the reported event cannot be confirmed.The instructions for use identifies death, vasospasm, stroke, and thromboembolic events as potential complications associated with use of the device.The fred device is contraindicated for use in patients in whom anticoagulant, anti-platelet therapy, or thrombolytic drugs are contraindicated.
Event or Problem Description
It was reported that the patient presented to the hospital with a 20mm ruptured aneurysm of the internal carotid artery (ica) and a shunt was placed.A fred stent was implanted into the ica across the aneurysm the next day.The patient was noted to have delayed flow and vasospasm post procedure.The patency and apposition of the fred near the middle portion of the stent was unclear, but it was confirmed that the fred was fully open proximal and distal to that location.It appeared that a clot was forming outside of the fred stent and the physician administered verapamil, which improved flow.Numerous and prolonged attempts were made to increase the patient's blood pressure and blood flow.Upon removal of the guide catheter, the physician noticed that blood flow to the ica was restricted due to vasospasm in the femoral artery.The physician resolved with pressure rather than use of a closure device.The patient apparently suffered a stroke the next day, the location and cause of which is unknown, and later passed away.Based on reported information, there is no indication that the design or function of the fred contributed to the well-recognized complications.However, the indications for fred in this setting are unclear, given that it was reported that no dapt was used.

• Brand Name: FRED 27
• Common Device Name: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 11579528
• Report Number: 2032493-2021-00089
• Device Sequence Number: 14357894
• Product Code: OUT
• UDI-Device Identifier: 00842429106747
• UDI-Public: (01)00842429106747(11)200507(17)230430(10)2005075BG
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/26/2021

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: 04/30/2023
• Device Model Number: FRED4026-PMA
• Device Lot Number: 2005075BG
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2021
• Initial Report FDA Received Date: 03/27/2021
• 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: Death