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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 02/15/2019 |
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 anastomosis of the left limb.Approx.18 months post index procedure, avf stenosis was reported.This was treated with medication and revascularization of the anastomosis using a non-mdt pta the same day.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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Patient is a former smoker with a medical history of hypertension, hyperlipidemia, diabetes, pad,renal insufficiency and previous pta 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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Cec assessed the event as related to the index device and not related to the index procedure or paclitaxel.Cec commented that the pci of the target limb was clinically driven and involved the target lesion.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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