MAUDE Adverse Event Report: MICROVENTION, INC. FRED X27; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number XFRED4017-MVE

Device Problem Retraction Problem (1536)

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

Event Date 02/20/2024

Event Type  Injury  

Event Description

It was reported that a microcatheter is positioned in the anterior communicating artery (acm).Once the position is secured, the fred begins to advance.During advancement of the fred, the access inside the microcatheter feels hard.Controlled release is initiated trying to preserve the acp.By continuing to release the diverter, the system crashes and the fred must be recaptured.It is difficult for him to climb the aci curve and partially recovers since the system does not respond.It must be lowered with the stent partially open to the 6f guiding catheter to be able to remove it.When attempting to remove the stent, the fred does not come out of the microcatheter.The patient is reported to be fine.

Manufacturer Narrative

A search for non-conformances 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 stated to be available for return to the manufacturer for evaluation but has not yet been returned.The reported issue could not be confirmed.If the device is received at a later date, an investigation will be performed and a supplemental mdr will be submitted.The instructions for use (ifu) identifies device retraction difficulty as potential complications associated with use of the device.

• Brand Name: FRED X27
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 18899300
• MDR Text Key: 337619153
• Report Number: 2032493-2024-00215
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00842429107508
• UDI-Public: (01)00842429107508(11)230411(17)260331(10)0000345090
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: P180027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: XFRED4017-MVE
• Device Lot Number: 0000345090
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/11/2023
• 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
• Treatment: CHAPERON 6F; HEADWAY 27
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female