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

Model Number FRED4017

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

Patient Problems Cardiac Arrest (1762); Headache (1880); Convulsion/Seizure (4406); Hemorrhagic Stroke (4417); Ruptured Aneurysm (4436)

Event Type  Death  

Manufacturer Narrative

The lot number was not provided; therefore, a search for production-related ncrs could not be performed.The device was implanted in the patient and not returned to the manufacturer for evaluation; therefore, the alleged event cannot be confirmed.The instructions for use (ifu) identifies headache, seizure, rupture or perforation of the aneurysm, hemorrhage, including intracranial hemorrhage, and death 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: a patient presented with diplopia and left-sided loss of vision.Left ica angiogram revealed a 29× 27× 26mm sized left ica supraophthalmic segment aneurysm.The patient was treated with a fred stent and adjunctive coiling with total occlusion of the aneurysm sac.There was no intraventricular or subarachnoid hemorrhage on posttreatment ct.The patient developed sudden onset severe headache 17 hours after the procedure and ct showed diffuse subarachnoid hemorrhage extending into the prepontine cistern.The patient had a seizure followed by cardiac arrest while in the ct scanner.Immediately after resuscitation, ct revealed interval massive subarachnoid and intraventricular hemorrhage with hydrocephalus due to the second rupture.The patient later passed away.Several attempts to obtain additional case information were unsuccessful.

• 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: 12491919
• MDR Text Key: 272104219
• Report Number: 2032493-2021-00382
• 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: FRED4017
• 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): Death
• Patient Age: 36 YR