MEDTRONIC HEART VALVES DIVISION EVOLUT PRO TRANSCATHETER AORTIC VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
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Model Number EVOLUTPRO-26 |
Device Problems
Degraded (1153); Material Split, Cut or Torn (4008)
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Patient Problem
Cusp Tear (2656)
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Event Date 01/01/2023 |
Event Type
Injury
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Event Description
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Medtronic received information that 3 years 3 months following the implant of this transcatheter bioprosthetic valve, small vessel disease (svd) was suspected to have occurred but the cause was unknown.The physician suspected a leaflet tear.4 years and 3 months following the implant of the valve, surgery was subsequently performed to replace the valve with a non-medtronic valve.The valve was explanted via median sternotomy, and a sutureless non-medtronic surgical valve was implanted.When the transcatheter valve was removed and inspected, holes in 2 locations were visually confirmed.The surgery was successful and the patient was discharged from the hospital.No additional adverse patient effects were reported.
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Manufacturer Narrative
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Date is approximate.Month and year are confirmed valid.Medtronic has requested additional information pertaining to this reportable event.If additional reportable information is received, a supplemental report will be submitted. select patient information cannot be documented in the file due to regional privacy regulations. 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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Manufacturer Narrative
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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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Event Description
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Additional information was received that, per the physician, the leaflet tear confirmation has not been clearly determined.Per the physician, the cause of the holes in the explanted transcatheter valve was unknown.It was reported that the team received request from the physician that they would like to know the cause of the holes from the investigation.No adverse patient effects were reported.
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