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Model Number FRED3536 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Stenosis (2263); Hemorrhagic Stroke (4417); Ruptured Aneurysm (4436)
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Event Type
Death
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Manufacturer Narrative
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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 analysis; therefore, the alleged event cannot be confirmed.The instructions for use (ifu) identifies stenosis of stented segment, hemorrhage, including intracranial hemorrhage, rupture or perforation of the aneurysm, and death as potential complications associated with use of the device.
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Event Description
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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 treatment of an acutely ruptured, partially thrombosed aneurysm of the left middle cerebral artery (mca) with a fred device, the patient developed in-stent stenosis that was treated with balloon angioplasty, which improved the stenosis.1.5 months after treatment, the patient had left anterior cerebral artery territory stroke with an mrs score of 2.Iv vaso ct angiography showed serpentine configuration of the residual aneurysm lumen extending into lower mca trunk.The patient presented with altered mental status 4 months after treatment and ct showed parenchymal and intraventricular hemorrhage with subfalcine herniation.The patient later passed away.Several attempts to obtain additional case information were unsuccessful.
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Search Alerts/Recalls
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