Catalog Number IAV06008008P |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hemorrhage/Bleeding (1888); Stenosis (2263)
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Event Date 12/29/2023 |
Event Type
Injury
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Event Description
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During the index procedure a impact av access was used to treat the left arm. approximately 14 months post procedure patient suffered restenosis of left swing point. patient presented with prolonged bleeding.Underwent diagnostic fistulagram with possible intervention.Balloon angioplasty was performed.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 not related to the device, procedure or paclitaxel.The sponsor assessed the event as possibly related to the device and not related to the procedure or paclitaxel.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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