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

Model Number UNKNOWN

Device Problems Material Twisted/Bent (2981); Adverse Event Without Identified Device or Use Problem (2993); Activation Failure (3270)

Patient Problems Obstruction/Occlusion (2422); Ischemia Stroke (4418)

Event Type  Injury  

Manufacturer Narrative

The lot numbers were not provided; therefore, a search for production-related ncrs could not be performed.The devices were implanted in the patient and not returned to the manufacturer for analysis; therefore, the alleged product issues cannot be confirmed.The instructions for use (ifu) identifies thrombosis and stroke as potential complications associated with use of the device.

Event Description

As reported through the article titled, "flow redirection endoluminal device (fred) with or without adjunctive coiling in treatment of very large and giant cerebral aneurysms," published in clinical neuroradiology and reviewed by company on august 20, 2021: post aneurysm treatment with a fred device, two patient's developed in-stent stenosis requiring balloon angioplasty.Additionally, during follow-up, two other patients developed ischemic complications.The first in-stent stenosis, involved an 8 × 5 × 67mm fusiform right vertebrobasilar aneurysm, treated with 3 fred stents telescopically.There was torsion at the second fred, where balloon dilatation was performed.The second in-stent stenosis case involved a saccular left paraophthalmic aneurysm measuring 28 × 21 × 19mm.The stent was not fully opened at the proximal part which required subsequent balloon angioplasty.In regards to the early (>1 month) ischemic complication, it occurred in a patient with fusiform right vertebrobasilar artery aneurysm had transient symptoms (vertigo, swallowing disorder) due to minor stroke related to involvement of perforating branches most probably due to atherosclerotic background.The late (> 1 month) ischemic complication involved a patient with a paraophthalmic ica aneurysm that had been treated with a fred and adjunctive coiling.The patient had a minor stroke due to complete occlusion of the parent artery.".

• 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: 12492512
• MDR Text Key: 272669374
• Report Number: 2032493-2021-00381
• Device Sequence Number: 1
• Product Code: OUT
• 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: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2021
• 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: 08/20/2021
• 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; Disability