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

Model Number	FRED4007-PMA
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Intracranial Hemorrhage (1891); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)
Date of Event	03/10/2021
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 images were not provided; therefore, the reported event cannot be confirmed.The instructions for use identifies death and device migration as potential complications associated with use of the device.
Event or Problem Description
It was reported that a fred 27 stent was placed for the treatment of an unruptured anterior choroidal aneurysm.The fred stent was deployed successfully and appeared to have good wall apposition.On a final angiographic run, the fred was observed to be positioned roughly 2-3mm distal into the middle cerebral artery (mca) with slow flow.Additional angiographic runs revealed an occlusion of the mca due to thrombosis of the vessel.The physician attempted to remove and recapture the fred.An intraoperative bleed occurred during the manipulations within the blood vessel and the physician then coiled the ica to stop it.An external ventricular drain was placed to drain blood.The patient later passed away.
Additional Manufacturer Narrative
A4: 60kg.B5: additional information indicated that the patient had abnormal anatomy secondary to the patient's previous subarachnoid hematoma.

• Brand Name: FRED 27
• Common Device Name: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 11646247
• Report Number: 2032493-2021-00130
• Device Sequence Number: 3160489
• Product Code: OUT
• UDI-Device Identifier: 00842429106709
• UDI-Public: (01)00842429106709(11)200722(17)230630(10)20072255Z
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2021

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: 06/30/2023
• Device Model Number: FRED4007-PMA
• Device Lot Number: 20072255Z
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/10/2021
• Supplement Date Received by Manufacturer: 04/15/2021
• Initial Report FDA Received Date: 04/09/2021
• Supplement Report FDA Received Date: 05/14/2021
• 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
• Patient Age: 50 YR
• Patient Weight: 60