Model Number SBI060040080 |
Device Problems
Obstruction of Flow (2423); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Stenosis (2263)
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Event Date 07/05/2018 |
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 pta was used to treat the venous outflow.Approximately 7 months post index procedure, the patient suffered avf shunt stenosis.The patient was treated with medication and target vessel revascularisation using a non medtronic pta.The investigator and safety assessed the event as not related to the index device, procedure or paclitaxel.The patient recovered.
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Manufacturer Narrative
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An admiral extreme balloon catheter was used during index procedure.The shunt stenosis event occurred 9 months post procedure.If information is provided in the future, a supplemental report will be issued.
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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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Cec adjudicated event is not related to procedure or therapy but related to device.Revascularization is clinically driven target lesion revascularization.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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