MEDTRONIC HEART VALVES DIVISION EVOLUT FX VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
|
Back to Search Results |
|
Model Number EVOLUTFX-29 |
Device Problems
Failure to Advance (2524); Device Dislodged or Dislocated (2923)
|
Patient Problem
Vascular Dissection (3160)
|
Event Date 07/12/2023 |
Event Type
Injury
|
Event Description
|
Medtronic received information that during the implant of this transcatheter bioprosthetic valve, the valve paddles did not release from the delivery catheter system paddle pockets causing the valve to dislodge.A second valve was inserted into the patient, however, interfered with the first valve and was unable to be delivered.During the attempt to place the second valve, the first valve moved downward causing a dissection.No treatment was performed for the dissection.Ultimately, a second non-medtronic valve was placed inside the first valve.No additional adverse patient effects were reported.
|
|
Manufacturer Narrative
|
Concomitant medical products:section d information references the main component of the system.Other relevant device(s) are: product id: d- evolutfx-2329, serial/lot #: (b)(6), ubd: 13-feb-2025, udi#: (b)(4) ; product id: d-evolutfx-2329, serial/lot #: unknown, ubd: 13-feb-2025, udi#: product analysis: the valve remains implanted and the dcs was discarded; 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.
|
|
Manufacturer Narrative
|
Conclusion: the device history records for the valve and the first delivery catheter system (dcs) were reviewed and showed that these products met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.Dislodgement of the valve by the dcs is related to operator technique or experience.Often a hung paddle will resolve itself after a few heart cycles, but if it doesn¿t the operator can either pull slightly on the guidewire or gently push the delivery system forward to release the paddle.Events of this type do not indicate a device malfunction or a failure to meet manufacturing specifications.Vascular injuries such as dissection are known potential adverse patient effect per the device instructions for use (ifu), and are typically related to patient factors (anatomy, comorbidities, etc.), and/or procedural effects (sheath used, user technique, puncture cut location, etc.).In this event, the dissection was reportedly a result of an attempt to place a second valve, which caused the first (initially dislodged) valve to move downward and create a dissection.However, this could not be confirmed from the information available.Updated: h6 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.
|
|
Manufacturer Narrative
|
Conclusion: difficulties advancing the delivery catheter system (dcs) through the access vessel is known to be related to factors such as patient anatomy and physician technique, including guidewire and introducer sheath selection.In this case, it was noted that the system was unable to be advanced past the first dislodged valve.This indicates that the probable cause of the advancement difficulties was procedurally related, but this cannot be confirmed with the limited information available.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.
|
|
Search Alerts/Recalls
|
|
|