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Catalog Number SBI060040080 |
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 06/11/2019 |
Event Type
Injury
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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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Event Description
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During the index procedure, one medtronic standard pta was used to treat the venous outflow.Approximately 20.5 months post index procedure, the patient suffered avf shunt stenosis and was treated with medication and pta of the venous outflow.The patient recovered.The investigator and sponsor assessed the event as not related to the index device, procedure or paclitaxel.
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Manufacturer Narrative
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Additional information: lot number of device used during index procedure is provided.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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