Catalog Number M003SZAS30300C |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Stenosis (2263)
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Event Date 01/14/2016 |
Event Type
Injury
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Manufacturer Narrative
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Device remains implanted in patient.
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Event Description
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It was reported during a clinical study that after 24 months post procedure implant of the stent (subject device), a cta reveled a stenosis at the right middle cerebral artery bifurcation.The report mentions all vessels have good flow and a percent stenosis was not provided.No other information is currently available.
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Event Description
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It was reported during a clinical study that after 24 months post procedure implant of the stent (subject device), a cta reveled a stenosis at the right middle cerebral artery bifurcation.The report mentions all vessels have good flow and a percent stenosis was not provided.No other information is currently available.
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Manufacturer Narrative
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H4 manufacturing date ¿ added d4 expiration date - added the subject device is not available; therefore, visual and functional testing as well as physical analysis cannot be performed.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.Based upon medical review, the harm observed in the complaint is anticipated in nature as per the device risk assessment.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.The device was not returned.An assignable cause of anticipated procedural complication will be assigned to the reported event of patient parent vessel stenosis 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.Device remains implanted in patient.
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Search Alerts/Recalls
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