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

Model Number FREDJR3014

Device Problems Structural Problem (2506); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Obstruction/Occlusion (2422)

Event Date 10/28/2020

Event Type  Injury  

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 has not yet been returned to the manufacturer for evaluation.

Event Description

It was reported that the fred jr.Was implanted without incident along the m1 to treat a wide neck aneurysm.After implantation, the stent and vessel became occluded.A stent retriever was used to remove the stent from the patient.There was no reported sequela.

Manufacturer Narrative

The reported complaint is nonverifiable as the returned stent was too damaged to perform an investigation.The damage to the stent is consistent with an overload in force applied during removal from the patient with the use of a stent retriever.

Manufacturer Narrative

Additional information was received from the distributor stating that the obstruction in the stent was not due to thrombus, but rather due to an issue with the inner layer of the stent.The vessel that was occluded was the m1 segment of the right middle cerebral artery.The patient was administered prasugrel post-procedure even though the physician suspected the obstruction was due to the inner layer of the stent.The device was retuned to the manufacturer for analysis.The investigation is currently underway.

• Brand Name: FRED JR.
• Type of Device: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 11353925
• MDR Text Key: 232784767
• Report Number: 2032493-2021-00054
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00812636020747
• UDI-Public: (01)00812636020747(11)190819(17)220731(10)190819543
• Combination Product (y/n): N
• PMA/PMN Number: P180027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup,Followup
• Report Date: 04/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: FREDJR3014
• Device Lot Number: 190819543
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2021
• Date Manufacturer Received: 04/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR
• Patient Weight: 78