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

Model Number	FRED4508-PMA
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2021
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.Post procedural images were provided, which confirmed the reported issue.Without the return and evaluation of the device, the investigation cannot determine if a condition existed with the device that would have caused or contributed to the event.The instructions for use identifies 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 with good neck coverage.The physician was advised to use a longer stent; however, elected to use a short one.At 6 months angiographic follow-up run, the fred was observed to be compacted back past the neck of the anurysm.The patient was discharged the same day after follow-up angiogram.The physician stated that they will retreat the aneurysm with another flow diverter.

• Brand Name: FRED 27
• Common Device Name: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 11882103
• Report Number: 2032493-2021-00185
• Device Sequence Number: 3685656
• Product Code: OUT
• UDI-Device Identifier: 00842429106761
• UDI-Public: (01)00842429106761(11)200618(17)230531(10)200618586
• 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: 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): 05/25/2021

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: 05/31/2023
• Device Model Number: FRED4508-PMA
• Device Lot Number: 200618586
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2021
• Initial Report FDA Received Date: 05/25/2021
• 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