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 Death (1802); Hemorrhage, Cerebral (1889); Thrombus (2101)

Event Date 08/05/2020

Event Type  Death  

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 not returned to the manufacturer for evaluation and the alleged product issue could not be confirmed.The instructions for use (ifu) identifies vessel occlusion, vessel stenosis or thrombosis, bleeding or hemorrhage including intracerebral, and neurologic deficits including stroke and/or death as potential complications associated with use of the device.

Event Description

It was reported that treatment was performed for an unruptured right internal carotid artery (ica) terminus aneurysm.The fred device was placed in the ica to the origin of the a1 segment, across the middle cerebral artery (mca).Upon completion of the procedure, it appeared that the mca territory was not filling.Thrombus was identified in the blood vessel.Integrilin was administered immediately, which restored flow within 15-20 minutes.In several hours after the procedure, an intracerebral hemorrhage (ich) was identified in the left hemisphere, which was on the contralateral side from the implanted device.The patient died the next day on (b)(6) 2020 from a cerebral hematoma on the contra-lateral side.The death was reported to be related to the integrilin treatment.No device malfunction or information suggesting that the device may have caused or contributed to the adverse event and patient death was reported to the manufacturer.

• 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: 10497723
• MDR Text Key: 205872480
• Report Number: 2032493-2020-00238
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 00842429106655
• UDI-Public: (01)00842429106655(11)200507(17)230430(10)20050755H
• 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: 08/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 04/30/2023
• Device Model Number: FRED3507-PMA
• Device Lot Number: 20050755H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/05/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2020
• 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; Life Threatening; Required Intervention
• Patient Age: 79 YR