Catalog Number 1011340-40 |
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 07/07/2015 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).It is indicated that the device is not returning for evaluation; therefore, a failure analysis of the complaint device could not be completed.The investigation concluded that a definitive cause for the reported patient effect could not be determined.A review of the lot history record revealed no non-conformances that would have contributed to the reported event.It should be noted that the reported patient effect of restenosis is a known observed and potential patient effect as listed in the instructions for use (ifu).Although a conclusive cause for the reported patient effects and the relationship to the product, if any, cannot be determined, there is no indication of a product quality issue with respect to manufacture, design, or labeling.
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Event Description
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It was reported that on (b)(6) 2013, an acculink stent was successfully implanted in the left internal carotid artery lesion.During a follow-up visit, on (b)(64) 2015, an ultrasound displayed increased velocities of the left internal carotid artery, indicating re-stenosis.On (b)(6) 2015, the patient was hospitalized.Another stent was implanted in the 90% re-stenosed left internal carotid artery.The stenosis resolved without sequela.On (b)(6) 2015, the patient was discharged home.There was no additional information provided.
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Search Alerts/Recalls
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