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

Model Number UNKNOWN

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Activation Failure (3270)

Patient Problems Transient Ischemic Attack (2109); Stenosis (2263); Ischemia Stroke (4418)

Event Type  Injury  

Manufacturer Narrative

A search for non-conformances associated with the devices' part/lot number combination could not be performed as the lot and part numbers are unknown.The device was implanted in the patient and not returned to the manufacturer for evaluation.Procedural images were not provided; therefore the reported event could not be confirmed.The instructions for use (ifu) identifies in-stent thrombosis and stenosis of the stented segment as potential complications associated with use of the device.

Event Description

As reported through the article titled, "efficacy of the flow re direction endoluminal device for cerebral aneurysms and causes of failed deployment" during a single-center retrospective study the angiographic and clinical data of consecutive patients treated with the fred for cerebral unruptured aneurysms from june 2020 to may 2021 the following cases were reported: ischemic infarction occurred in one patient with transient paralysis of the arm during the perioperative period.No permanent morbidity or mortality was observed.The post-procedural pru with the administration of psg was significantly decreased compared to pre-treatment pru with the administration of cpg (146 (108.8-178.3) vs 207 (153.0-225.5), p<0.01).Angiographic follow-up was performed at 3 and 6 months after the procedure, and occlusion rate and in-stent stenosis were assessed.The occlusion rate was evaluated using the o'kelly-marotta (okm) grading scale [7].Okm grading scales c and d were defined as adequate occlusion.Patients with technical failure to deploy the fred were excluded from angiographic follow-up but were included in the clinical follow-up.In-stent stenosis of greater than 50% was recorded in one patient; inadequate occlusion rate (grade a) was found in two patients at the 3 months follow-up; inadequate occlusion rate (grade b) was found in four patients at the 3 month follow-up; inadequate occlusion rate (grade b) was found in one patient at the 6 month follow-up.

• Brand Name: FRED
• 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: 13014381
• MDR Text Key: 285240594
• Report Number: 2032493-2021-00499
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P180027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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