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

Model Number XFRED4513-MVE

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

Patient Problem Thrombosis/Thrombus (4440)

Event Date 03/18/2021

Event Type  Injury  

Event Description

It was reported that while treating a posterior communicating artery (pcom) aneurysm with a fred x stent, thrombus appeared at the proximal end of the inner stent.The event was resolved with tirofiban and had no consequences for the patient.A dyna ct showed good wall apposition.The patient was a full responder to ass/clopidogrel.There was no report of harm or injury to the patient, who was doing fine.

Manufacturer Narrative

At the time this complaint was received, this product was an exported device that was not cleared or approved for marketing in the u.S.The complaint is being reported now as based on this product meeting similar product criteria.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 were not provide.Therefore, the alleged product issue cannot be confirmed.The instructions for use (ifu) identifies in-stent thrombosis as potential complications associated with use of the device.

Manufacturer Narrative

At the time this complaint was received, this product was an exported device that was not cleared or approved for marketing in the u.S.The complaint is being reported now as based on this product meeting similar product criteria.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 were not provide.Therefore, the alleged product issue cannot be confirmed.The instructions for use (ifu) identifies in-stent thrombosis as potential complications associated with use of the device.

Event Description

It was reported that while treating a posterior communicating artery (pcom) aneurysm with a fred x stent, thrombus appeared at the proximal end of the inner stent.The event was resolved with tirofiban and had no consequences for the patient.A dyna ct showed good wall apposition.The patient was a full responder to ass/clopidogrel.There was no report of harm or injury to the patient, who was doing fine.

Manufacturer Narrative

Additional information: h6, h10 (analysis of procedure images).Analysis of images: two images were provided with no date or time stamp.Both are lateral subtracted dsas of the ica.The first shows a small, wide necked pcom aneurysm measuring about 3mm; the pcom arises from the proximal base of the aneurysm.The second image show that the aneurysm has been coiled and that a fred has been implanted, spanning from the distal ica to the level of the ophthalmic artery.There is good wall apposition.There is attenuation of the contrast material in the proximal 1/3 of the stent, compatible with clot; the distal vasculature fills well, so this is likely not flow limiting.No image is provided to show the resolution of the clot that was reported following tirofiban therapy.

• 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: 13065403
• MDR Text Key: 285242126
• Report Number: 2032493-2021-00520
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00842429107546
• UDI-Public: (01)00842429107546(11)210115(17)231231(10)21011514U
• 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: 03/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: XFRED4513-MVE
• Device Lot Number: 21011514U
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2021
• 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): Required Intervention
• Patient Sex: Female