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Model Number MV-F552627 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Intracranial Hemorrhage (1891); Ischemia Stroke (4418); Ruptured Aneurysm (4436)
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Event Date 11/22/2021 |
Event Type
Death
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Manufacturer Narrative
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A search for non-conformances associated with the reported part/lot number combinations did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the devices.The devices were implanted in the patient and not available for evaluation.Medical imaging was provided and investigation of the images is currently ongoing.The instructions for use (ifu) identifies rupture or perforation of the aneurysm, hemorrhage, including intracranial hemorrhage (ich), subarachnoid hemorrhage (sah), and retroperitoneal, and death as potential complications associated with use of the device.The ifu states that placement of multiple implants may increase the risk of ischemic complications.
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Event Description
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It was reported that a patient with an unruptured va-pica aneurysm had four fred stents implanted with a telescoping technique.Four days later, a perforating branch infarction was noted and prasugrel was administered.The patient passed away due to bleeding from the ruptured aneurysm.The physician commented that this event was not caused by the product itself, but was rather due to the inherent limitations of flow diverters in general.
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Manufacturer Narrative
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Summary of image review: the provided images show a large/giant fusiform aneurysm of the vertebrobasilar junction.Post-treatment with 4 telescoping fred devices extending from the v4 segment of the vertebral to the basilar artery, there is marked stasis (expected) in the aneurysm and normal flow elsewhere.The complications described (perforating artery occlusion, delayed aneurysm rupture) are not fred specific complications, but well recognized unfortunate complications of flow diversion therapy of aneurysms, in particular large/giant/fusiform.
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Search Alerts/Recalls
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