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

Model Number FRED3507-PMA

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

Patient Problems Neurological Deficit/Dysfunction (1982); Thrombus (2101)

Event Date 07/17/2020

Event Type  Injury  

Manufacturer Narrative

A search for non-conformances 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 thus not returned to the manufacturer for evaluation.The root cause of the complaint cannot be determined.The instructions for use (ifu) identifies vessel occlusion, vessel stenosis or thrombosis, and neurologic deficits including stoke as potential complications associated with use of the device.

Event Description

It was reported that elective treatment was performed for an internal carotid artery (ica) aneurysm.The patient was on dapt (aspirin and brilinta).Deployment of the fred went well and the patient did well during the procedure.48 hours post-procedure, the patient had a stroke with severe hand weakness and mild arm weakness on the left.An angiogram was performed, which demonstrated an occlusion within the fred.Integrilin and tpa were delivered intra-arterially without effect; however, angiography showed there was good flow across the acom, filling the mca territory, so mechanical thrombectomy inside the stent was not attempted.The stent remains completely occluded.The patient has had slow improvement of the stroke symptoms, but there are still remaining deficits that are anticipated to get better over weeks with rehab and time.

• Brand Name: FRED 27
• Type of Device: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo, ca
• Manufacturer Contact: eva manus ; 35 enterprise drive; aliso viejo, ca
• MDR Report Key: 10411670
• MDR Text Key: 203092098
• Report Number: 2032493-2020-00210
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00842429106655
• UDI-Public: (01)00842429106655(11)190513(17)220430(10)19051355WM
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 04/30/2022
• Device Model Number: FRED3507-PMA
• Device Lot Number: 19051355WM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2019
• 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): Life Threatening; Required Intervention; Disability