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

Model Number XFRED2508-MVE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Intracranial Hemorrhage (1891); Thrombosis/Thrombus (4440)

Event Date 10/24/2021

Event Type  Death  

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 available for return to the manufacturer.However, procedure images were provided and are being reviewed.The instructions for use (ifu) identifies death and hemorrhage, including intracranial hemorrhage (ich), subarachnoid hemorrhage (sah) as potential complications associated with use of the device.

Event Description

It was reported that the patient came into the hospital with an acute, significant bleed of a right posterior inferior cerebella artery (pica) aneurysm.The patient was in critical condition, but treatment was attempted by placement of a fred x stent in front of the aneurysm.After placing the fred x, a thrombus formed that was not resolved, as the patient had already suffered serious injury from the acute bleed.After the closure, the patient suffered an additional stroke and died on the (b)(6).

Manufacturer Narrative

Additional information: h6, h10 (procedure images review).Intra-operative images were provided; however, the actual thrombosed stent is not imaged.The patient was likely predisposed to thrombosis given the hyperthrombogenicity associated with the acute sah and the small caliber of the artery where the fred was deployed.The physical device was not available for analysis; therefore, the investigation could not determine if a condition existed that would have caused or contributed to the reported event.

• 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: 13026792
• MDR Text Key: 282405854
• Report Number: 2032493-2021-00493
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00842429107355
• UDI-Public: (01)00842429107355(11)201210(17)231130(10)20121011VM
• 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,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/17/2021

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: XFRED2508-MVE
• Device Lot Number: 20121011VM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/17/2021
• Initial Date FDA Received: 12/17/2021
• Supplement Dates Manufacturer Received: 01/20/2022
• Supplement Dates FDA Received: 02/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2020
• 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): Death