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

Model Number	FRED4518-PMA
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2021
Type of Reportable Event	Malfunction
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.Images and videos were provided and reviewed by the product safety physician.The review of the customer provided media confirmed that the fred did not completely open at the proximal end as described in the complaint.One of the images shows what appears to be a separation of the inner and outer layers of the fred stent at the proximal section of the stent.The visual inspection of the provided media could not determine circumstances that led to this condition.Without the return of the implant, the investigation is limited and cannot determine the cause of the inability to open fully.
Event or Problem Description
It was reported that after deployment of the fred, the stent did not completely open at the proximal end.There was no reported patient injury or additional intervention.

• Brand Name: FRED 27
• Common Device Name: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 11319383
• Report Number: 2032493-2021-00038
• Device Sequence Number: 19855800
• Product Code: OUT
• UDI-Device Identifier: 00842429106785
• UDI-Public: (01)00842429106785(11)200513(17)230430(10)20051356U
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 02/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: FRED4518-PMA
• Device Lot Number: 20051356U
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2021
• Initial Report FDA Received Date: 02/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR