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

Model Number MV-F353627

Device Problem Activation Problem (4042)

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

Event Date 07/13/2021

Event Type  malfunction  

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.Post procedural images were not provided; therefore the reported event could not be confirmed.

Event Description

It was reported that the fred stent was implanted in a patient to treat a vertebral aneurysm.Upon deployment of the stent, two flares were noted to be inwardly inverted.Since the working length with fine mesh was properly apposed to the vessel wall, the stent was left implanted.No report of injury to the patient, who is being followed up with a caution for antiplatelet agents.

Manufacturer Narrative

Correction: e1 (contact: last name).

Manufacturer Narrative

Additional information was received.The patient was put on antiplatelet for a longer period of time than usual protocol to prevent clots from adhering during the follow-up period.The patient was doing well without any complications.Treated vessel measured 3mm distal, 3.2mm proximal and 3.4mm around aneurysm.The device was not returned for evaluation; therefore, the product analysis could not be performed.However, information was obtained on follow-up that indicated that the vessel being treated was 3.4 mm at its largest treated diameter and 3.0 mm at the smallest treated diameter, given this and that it is recommended that the diameter of the fred stent diameter be 0.5 mm larger than the vessel being treated, the 3.5 mm diameter fred stent used may have contributed to the stent flared ends given that the fred stent used was so close to the vessel diameter.Additionally, follow-up information indicates that the patient was placed on extended medication (dapt) to try to prevent any complications from the apposition/flared ends issue.The fred instruction for us (ifu) directs the user to "select an appropriate-sized fred system according to the size of the parent vessel/intracranial aneurysm neck." the fred system in-service guide recommends the stent diameter be 0.5mm larger than the vessel diameter being treated.

• Brand Name: FRED 27
• Type of Device: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 12316702
• MDR Text Key: 266366926
• Report Number: 2032493-2021-00323
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 04987892121821
• UDI-Public: (01)04987892121821(11)200702(17)230630(10)20070256T
• Combination Product (y/n): N
• PMA/PMN Number: P180027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: MV-F353627
• Device Lot Number: 20070256T
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1