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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 06/01/2018 |
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, an admiral xtreme pta balloon catheter was used to treat the anastomosis of the left arm.Approximately 41 weeks post index procedure, the patient suffered avf stenosis.Revascularization of the target lesion (anastomosis) was carried out the same day.The investigator has assessed the event is not related to device, procedure or paclitaxel.Patient recovered.
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Manufacturer Narrative
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Safety assessed the event as not related to device, procedure or paclitaxel.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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