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

Model Number	FRED4528-PMA
Medical Device Problem Codes	Separation Failure (2547); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2021
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 stent was returned without the original pusher.However, the stent was able to fully open and detach from a new pusher wire during the investigation.The damage to the tantalum wire is consistent with the stent being retrieved with a snare.The non-returned pusher is a critical component for this investigation; without the return and physical evaluation of the pusher, the complaint is considered non-verifiable.
Event or Problem Description
It was reported that a flow diverter device (fred 27 stent) used for treatment of a paraclinoid aneurysm would not release from the delivery pusher wire.The flared ends of the stent were open just enough to be loose from the pusher wire but the stent would not open fully.A snare was used to removed the device without any issue and the case was ended without treatment of the aneurysm.The patient suffered no consequences due to the procedure or post procedure and was discharged the next day.

• Brand Name: FRED 27
• Common Device Name: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 11971327
• Report Number: 2032493-2021-00222
• Device Sequence Number: 3388338
• Product Code: OUT
• UDI-Device Identifier: 00842429106792
• UDI-Public: (01)00842429106792(11)191209(17)221130(10)19120953HM
• 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: 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): 06/09/2021

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: 11/30/2022
• Device Model Number: FRED4528-PMA
• Device Lot Number: 19120953HM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2021
• Initial Report FDA Received Date: 06/09/2021
• 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
• Patient Age: 71 YR