Catalog Number IAV08006008P |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Insufficient Information (4580)
|
Event Date 09/15/2023 |
Event Type
Injury
|
Event Description
|
During the index procedure a in.Pact av access was used to treat the left proximal humeral region.Approximately 4 months post procedure patient suffered non-functioning av fistula, abandonment. patient presented with nonfunctioning fistula.Attempts were made to salvage the arterial-venous fistula but were unsuccessful.Perm catheter placement.Patient in need of hemodialysis upon admission. the event was treated with percutaneous intervention.Patient recovered.
|
|
Manufacturer Narrative
|
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.
|
|
Manufacturer Narrative
|
Patient suffered avf thrombosis of the cephalic outflow resulting in fistula abandonment 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.
|
|
Search Alerts/Recalls
|