Model Number M003UZAS40300 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Infarction, Cerebral (1771)
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Event Date 10/07/2017 |
Event Type
Injury
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Manufacturer Narrative
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This is the first of 2 reports.Subject device remains implanted.
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Event Description
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It was reported that 1-month post-procedure of stent-assisted coiling with two subject stents, the patient experienced ischemic stroke with regressive right paresis and slurred speech.Kardegic 75mg/day medication was stopped 15 days before the adverse event date.This adverse event of ischemic stroke was assessed as non-serious and was resolved, without sequelae the next day.
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Manufacturer Narrative
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The intended use for the device was for treatment.The reported complaint could not be confirmed and it could not be definitively determined if the device failed to meet specifications because the product was not returned.Due to the automated mes system (manufacturing execution system), there are controls in the manufacturing process to ensure the product met specifications upon release.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.An assignable cause of anticipated procedural complication will be assigned to the reported event as a product related root cause does not apply and the issue is due to a known physiological effect of the procedure and/or patient condition noted with the directions for use, product labeling and/or risk documentation files.
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Event Description
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It was reported that 1-month post-procedure of stent-assisted coiling with two subject stents, the patient experienced ischemic stroke with regressive right paresis and slurred speech.Kardegic 75mg/day medication was stopped 15 days before the adverse event date.This adverse event of ischemic stroke was assessed as non-serious and was resolved, without sequelae the next day.
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Search Alerts/Recalls
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