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Catalog Number SBI050040080 |
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 11/20/2018 |
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 standard pta was used to treat the anastomosis of the left limb.Approximately 14 months post index procedure, avf stenosis was reported.This was treated with medication and revascularization of the anastomosis using a non-medtronic pta.The investigator and sponsor assessed the event as not related to the device, procedure or paclitaxel medication.The patient recovered.
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Manufacturer Narrative
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The patient is a previous smoker and has a medical history of hypertension, hyperlipidemia, diabetes, renal insufficiency, pad, and previous revascularisation of the anastomosis.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Lot number of device used during index procedure 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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