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

Model Number MV-F502927

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 12/15/2021

Event Type  malfunction  

Event Description

It was reported that when about 20% of the stent was deployed, the distal part of the fred slipped and the microcatheter moved to proximal.The fred was attempted to be re-sheathed for re-deployment, but dropped off in the microcatheter.The fred was then retrieved along with the microcatheter and another set of fred and a microcatheter were used to continue the procedure, which was completed successfully.There was no impact to the patient.

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 not returned to the manufacturer for analysis; therefore, the alleged product issue cannot be confirmed.

Manufacturer Narrative

Summary of device evaluation: the reported complaint is unconfirmed as the stent did not detach prematurely at any point during the investigation.The investigation found no other damage or anomaly that would have contributed to the reported complaint.The returned microcatheter was found to be compressed at the distal section; however, there is no indication that this condition resulted in the stent releasing just distal to the hub.The physical evaluation of the device could not identify the conditions or circumstances that led to the damage, but the damage is consistent with the device experiencing forces over specification.

• 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: 13232990
• MDR Text Key: 285047617
• Report Number: 2032493-2022-00017
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 04987892121968
• UDI-Public: (01)04987892121968(11)201021(17)230930(10)20102156W
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P180027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: MV-F502927
• Device Lot Number: 20102156W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2020
• 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