MEDTRONIC HEART VALVES DIVISION EVOLUT PRO PLUS DCS; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
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Model Number D-EVPROP2329US |
Device Problem
Failure to Advance (2524)
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Patient Problems
Low Blood Pressure/ Hypotension (1914); Stenosis (2263); Heart Block (4444)
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Event Date 01/16/2023 |
Event Type
Injury
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Manufacturer Narrative
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Product analysis: the device 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.
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Event Description
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Medtronic received information that during the implant of this transcatheter bioprosthetic valve, in a patient with horizontal 72-degree bicuspid type 0 valve, via access site, using a non-medtronic wire with an inline sheath, the delivery catheter system (dcs) was unable to advance through the aortic valve.The dcs was withdrawn from the patient.A non-medtronic wire was replaced with another non-medtronic wire; an 18fr x 65cm non-medtronic sheath was inserted.Subsequently, the dcs was inserted again but was unable to advance through the aortic valve.It was noted the left ventricular lumen was narrowed.Since the blood pressure repeatedly decreased when the wire was inserted, percutaneous cardiopulmonary support (pcps) was administered.At this point, an hour delay was reported when the loading process was completed.Two additional attempted insertions made were unsuccessful.The valve, dcs, and loading system were replaced.The physician performed a snare technique via pcps to advance the new dcs through the aortic valve successfully.No recapture was performed.The new valve was placed in the intended implant position.No additional adverse patient effects were reported.
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Manufacturer Narrative
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Corrected data: field d10 was inadvertently left of on supplemental medwatch regulatory report#2025587-2023-00432, follow up#001 continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: evproplus-23us, serial/lot #: (b)(6), ubd: 2024-aug-22, udi#: (b)(4).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 following the implant of the valve, complete heart block occurred.Subsequently a permanent pacemaker was implanted.No additional adverse patient effects were reported.
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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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Manufacturer Narrative
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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 patient had a horizontal 72-degree aorta and a bicuspid type 0 valve.This indicates that the probable cause of the advancement difficulties was patient anatomy, but this cannot be confirmed with the limited information available.Advancement difficulties do not typically indicate a device malfunction or a failure to meet manufacturing specifications.Stenosis is a known potential adverse patient effects per the device instructions for use (ifu), and is typically related to patient factors (anatomy, comorbidities, etc.), and/or procedural effects (sheath used, user technique, puncture cut location, etc.).Based on the limited information available, an assignable root cause cannot be determined and the relationship to the dcs could not be established.There was no information to suggest a device malfunction or a failure to meet manufacturing specifications was related to these events.Hypotension is a known potential adverse effect per device ifu.It is an effect that is highly dependent on the patient's pre-procedural condition and can occur despite a normally functioning device or model implant procedure, and a conclusive cause could not be determined from the limited information available.Conduction disturbances are known potential adverse effects per the ifu, and can be resolved with the implant of a permanent pacemaker with the risk-benefit ratio in favor of the transcatheter aortic valve, as occurred in this case.Factors that may impact the development of conduction disturbances include depth of implant, baseline conduction defects, and anatomical considerations, but a conclusive cause could not be determined from the limited information available.There is no information to suggest a device malfunction or a failure to meet manufacturing specifications.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.
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