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

Model Number	FRED5019-PMA
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Codes	Ischemia (1942); Thrombosis/Thrombus (4440)
Date of Event	08/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A search for non-conformance associated with this 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 not returned to the manufacturer for analysis; therefore, the alleged product issue cannot be confirmed.The instructions for use (ifu) identifies vessel occlusion, vessel stenosis or thrombosis, and neurologic deficits including stroke as potential complications associated with use of the device.
Event or Problem Description
It was reported that after the fred was deployed in the right internal carotid artery (ica), post-procedure imaging demonstrated a widely patent stent with good filling of the mca and aca territories.Five days post-procedure, the patient was readmitted with neurological changes and imaging confirmed a total thrombotic occlusion of the fred and the ica, as well as narrowing of the proximal fred.The proximal fred was fully expanded with a balloon and a stent was implanted in the ica, which increased flow into the mca.An mri performed the next day demonstrated an mca territory infarct.The patient was still hospitalized at the time of this report.

• Brand Name: FRED 27
• Common Device Name: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 10582067
• Report Number: 2032493-2020-00266
• Device Sequence Number: 2954704
• Product Code: OUT
• UDI-Device Identifier: 00842429106839
• UDI-Public: (01)00842429106839(11)200527(17)230430(10)200527569
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P180027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 09/24/2020

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: Other
• Device Expiration Date: 04/30/2023
• Device Model Number: FRED5019-PMA
• Device Lot Number: 200527569
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2020
• Initial Report FDA Received Date: 09/24/2020
• 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: Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 61 YR