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Catalog Number SBI060040080 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Thrombus (2101); Stenosis (2263)
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Event Date 06/03/2019 |
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 index procedure, an admiral xtreme balloon catheter was used to treat the left anastomosis.Approximately 20 months post procedure, patient suffered avf shunt stenosis which was treated with medication and revascularization using a non medtronic pta balloon catheter.Patient recovered.Investigator and sponsor assessed event is not related to device, procedure or paclitaxel.Cec adjudicated event is related to device and revascularization as a clinically driven target lesion revasc.It was reported that there was thrombus in circuit.
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Manufacturer Narrative
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Additional information: the event was also treated with thrombectomy.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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