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

Model Number XFRED3516-MVE

Device Problem Activation Failure (3270)

Patient Problems Muscle Weakness (1967); Speech Disorder (4415); Ischemia Stroke (4418)

Event Date 11/02/2021

Event Type  Injury  

Event Description

It was reported through a (b)(6) study that during treatment of an aci aneurysm with a fred x flow diverter stent, the flared ends did not appear in the correct alignment after deployment.One of the flared ends was rolled outwards.An attempt was made to model the flared end to the vessel wall.A control angiography after one day revealed the stent to looked fine.Reportedly, the patient experienced dysarthria, right side weakness and delayed infarct.Clinical impact described as patient had a permanent deficit.The patient neurological evaluation at discharge was mrs score 1.

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 is not available for return to the manufacturer for analysis, and procedure images not provide.Therefore, the alleged product issue cannot be confirmed.If additional information is received, microvention, inc., will issue a supplemental mdr report.

• Brand Name: FRED X27
• 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: 12917562
• MDR Text Key: 286260816
• Report Number: 2032493-2021-00476
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00842429107454
• UDI-Public: (01)00842429107454(11)210119(17)231231(10)21011911A
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P180027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: XFRED3516-MVE
• Device Lot Number: 21011911A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2021
• 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): Disability; Required Intervention
• Patient Sex: Female