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Model Number 172020-LVISJ |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Death (1802); Hemorrhage, Cerebral (1889); Thrombus (2101); Vascular System (Circulation), Impaired (2572)
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Event Date 12/03/2019 |
Event Type
Death
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Manufacturer Narrative
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A search for non-conformance 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 stent was implanted and the delivery system was not returned for evaluation.The root cause cannot be determined.The instructions for use (ifu) identifies vascular occlusion, vessel stenosis, and neurologic insufficiencies including stroke and death as potential complications associated with the use of the device.
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Event Description
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It was reported that stent-assisted coil embolization was performed.After access through tortuous anatomy, the lvis jr.Stent was successfully deployed from the left a1 to the right a2 and imaging confirmed full stent expansion.Three coils were then successfully placed at the treatment site without incident.Final procedure images demonstrated a clot in the middle of the stent.A bolus of integrilin was administered and tpa was delivered directly to the clot.As the clot was starting to dissolve, a spontaneous bleed was discovered at the p-com where no interventional work was done or devices had been placed.Integrilin and heparin were reversed, without success.Multiple devices were then used to stop bleeding, also without success.It was reported that the patient had insufficient blood flow to the left hemisphere of the brain at that point.The patient is reported to have expired.The exact date and cause of the patient's death is unknown.
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Search Alerts/Recalls
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