MEDTRONIC HEART VALVES DIVISION EVOLUT PRO TRANSCATHETER AORTIC VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
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Model Number EVOLUTPRO-26 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Cardiac Arrest (1762); Non specific EKG/ECG Changes (1817); Low Blood Pressure/ Hypotension (1914)
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Event Date 02/02/2023 |
Event Type
Death
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Manufacturer Narrative
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Product analysis: no product was returned.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.
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Event Description
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Medtronic received information that during implant of this transcatheter bioprosthetic valve, during anesthetic induction, qrs widening and hypotension was reported.The valve was implanted quickly with good implant positioning and the blood pressure did not recover.An echocardiogram revealed apical akinesia/dyskinesia.Pulseless cardiac response evolved and the patient subsequently died.
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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.
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Event Description
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Additional information was received which reported that the patient's cause of death was pulseless electrical activity.Per the physician, the valve did not cause or contribute to the death.
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Event Description
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Additional information was received which confirmed that the cause of the pea was not specifically known.
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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.
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Manufacturer Narrative
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Updated data: h6 - method results and conclusion codes conclusion: the device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.Images were submitted to medtronic for review.The excerpt of the image subject matter expert (sme) review report follows: the media file was provided for review for the event description above.Patient¿s executive summary was provided for anatomical review.Annulus perimeter and perimeter derived diameter is 72.7 millimeter (mm) /23.1 mm suggesting a 29 mm evolut per sizing.However, it was reported that a 26 mm evolut was implanted in this patient.A fluoroscopic image of the valve load inspection was performed, and no misload was identified.The cusp overlap view was used and depth during early deployment was approximately 0-1mm at the non-coronary cusp (ncc).Medtronic recommends verifying depth at the left coronary cusp (lcc) in a left anterior oblique (lao) projection prior to final release.However, lao view was not provided so depth at the lcc is unknown.The depth was approximately 3mm during early stages of release; and a sudden full release was noted with final depth noted to be 5-6mm at the ncc.Per medtronic best practices, depth >5mm at the ncc could potentially cause conduction disturbances.Cause of pre-implant hypotension is unknown and even though the final depth could be related to the further decompensation, there is not enough information and this report is inconclusive.The medical safety assessment was performed.The excerpt of the subject matter expert (sme) review report follows: the primary adverse event of qrs widening and hypotension led to apical akinesia/dyskinesia, pulseless electrical activity (pea) and death.Based on the available information, the qrs widening and hypotension were related to anesthesia and are not related to the valve.No further action is required.Hypotension is a known potential adverse effect per the device instructions for use (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.Conduction disturbances are known potential adverse effects per the device ifu.Factors that may impact the development of conduction disturbances include depth of implant, baseline conduction defects, and anatomical considerations.Per the medical safety review, these events were due to the anesthesia and not due to the valve.Patient death is a potential risk associated with the implantation of a bioprosthesis valve per the device ifu.A procedure- or valve-related death is an inherent risk when the patient condition is such that a tav is needed to sustain cardiac function, and it can occur despite an ideal implant procedure or device functionality.Per the physician, the valve did not cause or contribute to the death.However, with the limited information available, a conclusive relationship between these devices and death could not be established.This event does not indicate device misuse or malfunction.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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