MAUDE Adverse Event Report: MICROVENTION, INC. FRED 27; FLOW DIVERTER

Model Number FRED3516-PMA

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

Patient Problems Muscle Weakness (1967); Thrombosis/Thrombus (4440)

Event Date 02/21/2022

Event Type  Injury  

Manufacturer Narrative

A search for non-conformance's 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 was implanted in the patient and not available for return to the manufacturer.Procedural images were not available.Therefore, the event as described could not be confirmed.If further information is received, a supplemental report will be submitted.The instructions for use (ifu) identifies stent thrombosis as a potential complication associated with use of the device.

Event Description

It was reported that a fred stent was implanted from the m2 to m1 segment of the mca to treat an aneurysm of the bifurcation that was previously clipped and had recanalized.Upon waking from anesthesia, the patient reported left sided weakness.The patient was brought back, "re-accessed," and thrombus was observed on the outside and inside of the at the ostium for the inferior m2 division, which the stent was crossing.A bolus of integrilin was administered as well as an integrilin infusion.The thrombus resolved and by the next morning the patient's condition was back to baseline.It was reported that the patient could be a plavix nonresponder.

• Brand Name: FRED 27
• 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: 13935510
• MDR Text Key: 288137732
• Report Number: 2032493-2022-00119
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00842429106679
• UDI-Public: (01)00842429106679(11)201029(17)230930(10)20102963X
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P180027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: FRED3516-PMA
• Device Lot Number: 20102963X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2020
• 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
• Patient Sex: Male