Catalog Number SBI070040080 |
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 05/30/2019 |
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 left venous outflow.Approximately 20.5 months post procedure the patient suffered avf shunt stenosis and was treated with a non-medtronic pta of the venous outflow and medication.The patient recovered and the investigator and sponsor assessed the event as not related to the device, procedure or paclitaxel.
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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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Manufacturer Narrative
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Additional information: cec adjudicated event is related to device and revascularization as clinically driven target lesion revasc.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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