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Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Hematoma (1884); Rupture (2208); Obstruction/Occlusion (2422); Unspecified Tissue Injury (4559); Restenosis (4576)
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Event Date 04/01/2020 |
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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A journal article was submitted detailing a retrospective single-center study to evaluate efficacy of percutaneous transluminal angioplasty (pta) for the endovascular management of arteriovenous fistula (avf) dysfunction in patients with end-stage renal disease (esrd).135 patients were included in the study who underwent endovascular treatment for a dysfunctional native avf.Medtronic¿s standard pta balloons (4-9mm) were used during the procedure to treat avf dysfunction.The balloon was maintained inflated for 2 minutes, and the procedure was repeated if necessary.Pta was technically successful in 100.0% of operations, with residual stenosis (>30%) in 5.2% of patients.Pta revealed clinical success in terms of adequate dialysis after the procedure in 97.0% of patients, with complications only in 7.4%.Complications reported include vasospasm (7 patients), ad hematoma (2 patients).Rupture is reported in 1 patient.During the follow-up period of 6 months the avf remained patent in 94 patients (median primary patency duration of 5.0 months).Dysfunction recurrence reported in 41 patients, restenosis (7 patients) and occlusion (34 patients).
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Manufacturer Narrative
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Title: (b)(6).Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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