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

Model Number FRED4528-PMA

Device Problems Separation Failure (2547); Activation Failure (3270)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/10/2021

Event Type  Injury  

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 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
• Type of Device: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise drive; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 11971327
• MDR Text Key: 256278168
• Report Number: 2032493-2021-00222
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00842429106792
• UDI-Public: (01)00842429106792(11)191209(17)221130(10)19120953HM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P180027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/10/2021
• Initial Date FDA Received: 06/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR