MEDTRONIC HEART VALVES DIVISION EVOLUT PRO PLUS VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
|
Back to Search Results |
|
Model Number EVPROPLUS-29US |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Dysphagia/ Odynophagia (1815); Fever (1858)
|
Event Date 08/31/2022 |
Event Type
Death
|
Manufacturer Narrative
|
Product analysis: the device remains implanted, and no procedural images were submitted for review; therefore, no product analysis can be performed.Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.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.
|
|
Event Description
|
Medtronic received information that eight months and sixteen days following the implant of this transcatheter bioprosthetic valve, covid-19 vaccination was administered, and continuous fever was reported.It was noted the patient¿s level of activities of daily living had decreased and oral ingestion was difficult; a central venous catheter port was added.Nine months post-implant, the patient¿s breathing condition worsened.Subsequently, one day later, the patient died.The cause of death was unknown.Per the physician, the valve and the valve implant procedure contributing factors to the patient's death were unknown.
|
|
Search Alerts/Recalls
|
|
|