Model Number FGA21154-01 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hemorrhage, Subarachnoid (1893); Rupture (2208)
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Event Date 11/20/2019 |
Event Type
Injury
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Manufacturer Narrative
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A search for non-conformances associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device was not returned for evaluation.The root cause cannot be determined.The instructions for use (ifu) identifies rupture as a potential complication associated with the use of this device.
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Event Description
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It was reported that while treating a middle cerebral artery bifurcating aneurysm with a web device, the aneurysm was ruptured with a guidewire and a via 21 microcatheter during attempts to access the aneurysm prior to the introduction of the web.The case was terminated at that point.
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Manufacturer Narrative
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Clarifying details of the event were provided.It was reported that the guide wire (not a microvention device) was introduced in the aneurysm and the via was advanced over the guide wire into the aneurysm.During retraction of the guide wire, the via jumped forward.The aneurysm ruptured and a subarachnoid hemorrhage was stabilized shortly afterward by the neurosurgeon.At the time of the event, the patient remained stable.The patient is reported to be alive.
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Manufacturer Narrative
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Additional information was received on 2/12/2020: after the aneurysm rupture, the patient was stabilized in the angio suite and the bleed was stopped by a partially deployed coil.The patient was then taken to the operating room and the aneurysm was treated.
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Search Alerts/Recalls
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