Catalog Number IAV08004008P |
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 12/05/2023 |
Event Type
Injury
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Event Description
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During the index procedure a in.Pact av access was used to treat the left arm cephalic arch.Two in.Pact av access were used to treat the cephalic arch. approximately 6 months post procedure patient suffered restenosis cephalic arch. restenosis avf at index target lesion treated with stent graft and medtronic dcb for recalcitrant stenosis with improvement post pta and stenting. patient recovered.
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Manufacturer Narrative
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Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Manufacturer Narrative
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Additional information: the investigator assessed the event as probably related to the device and paclitaxel and causally related to the re-intervention procedure.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Search Alerts/Recalls
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