Catalog Number SBI050080080 |
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 01/22/2018 |
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 index procedure, a standard pta was used to treat the anastomosis in the left arm.Approximately 4 months post procedure, patient suffered shunt stenosis and revascularization of the anastomosis was carried out using a pta balloon.Patient recovered.Investigator assessed that event is not related to the study device, procedure or therapy.
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Manufacturer Narrative
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Lot number of admiral xtreme balloon catheter used index procedure provided.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 a 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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