Model Number 2AF284 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Chest Pain (1776); Pulmonary Valve Stenosis (2024)
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Event Date 05/30/2016 |
Event Type
Injury
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Manufacturer Narrative
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A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that approximately seven months post cryoablation procedure, the patient experienced chest pain.Computerized tomography (ct) scan images revealed stenosis in the left superior pulmonary vein (lspv).Less than one month later, surgical intervention was performed for the lspv, resolving the stenosis.No further patient complications have been reported as a result of this event.
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Manufacturer Narrative
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Event summary: the reported issue is a clinical issue and could not be verified through data file analysis.The data file analysis confirmed that catheter lot number 22842-97 was used on the date of the event for at least seven injections.No system error messages were recorded.The case was completed with cryo.The patient presented with a pulmonary vein stenosis approximately seven month after the procedure.The stenosis was corrected surgically.Final resolution: the reported issue is a clinical issue and could not be verified through data file analysis.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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