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

Model Number FRED4508

Device Problem Unintended Movement (3026)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 04/15/2021

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 device was implanted in the patient and not returned to the manufacturer for analysis.Additionally, procedural images were not provided; therefore, the reported event cannot be confirmed.The instructions for use identifies in-stent thrombosis as a potential complication associated with use of the device.

Event Description

It was reported that after implantation of a fred stent to treat an aneurysm of the left internal carotid artery, the proximal part of the stent moved distally and was no longer in the same position.It could not be determined if the aneurysm neck was still covered.A clot was observed in the second half of the stent and no contrast was visible distal to the stent.The patient was treated with aggrastat (tirofiban) in bolus immediately, then an infusion at 18 hours.The vessel was opened completely.The patient is still recovering, but is was reported to be improving.

• Brand Name: FRED
• 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
• MDR Report Key: 11853463
• MDR Text Key: 251674116
• Report Number: 2032493-2021-00166
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00811425021057
• UDI-Public: (01)00811425021057(11)190115(17)211231(10)19011552A
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P180027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/19/2021

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: 12/31/2021
• Device Model Number: FRED4508
• Device Catalogue Number: 140205HES-V
• Device Lot Number: 19011552A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/19/2021
• Initial Date FDA Received: 05/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/23/2020
• 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
• Patient Outcome(s): Required Intervention