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

Model Number	FRED3516-PMA
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Muscle Weakness/Atrophy (1967); Thrombosis/Thrombus (4440)
Date of Event	02/21/2022
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 2032493-2022-00119
• Device Sequence Number: 3952278
• Product Code: OUT
• UDI-Device Identifier: 00842429106679
• UDI-Public: (01)00842429106679(11)201029(17)230930(10)20102963X
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P180027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/22/2022

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2022
• Initial Report FDA Received Date: 03/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male