MEDTRONIC HEART VALVES DIVISION EVOLUT PRO PLUS VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
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Model Number EVPROPLUS-29US |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Death (1802); Cardiogenic Shock (2262); Regurgitation, Valvular (2335); Low Cardiac Output (2501); Valvular Insufficiency/ Regurgitation (4449)
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Event Date 10/12/2020 |
Event Type
Death
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Manufacturer Narrative
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Product analysis: the product remains implanted, therefore no product analysis can be performed.Conclusion: without return of the product, no definitive conclusions could be drawn regarding the clinical observation.Other relevant device(s) are: product id: d-evprop2329us, serial/lot #: (b)(4), ubd: 05-mar-2022, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
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Event Description
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Medtronic received information that during the implant of this transcatheter bioprosthetic valve, when the delivery catheter system crossed the native aortic valve, cardiac output was lost.Cardiopulmonary resuscitation (cpr) was initiated.The valve was implanted in a good position.Following implant, moderate aortic regurgitation was noted and cardiac output could not be regained.The patient went into cardiogenic shock and subsequently died.The cause of death was not received.It is unknown whether an autopsy was performed.
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Manufacturer Narrative
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Corrected data: the delivery catheter system (dcs) code was inadvertently omitted on the previous report.Product was discarded.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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