MEDTRONIC HEART VALVES DIVISION EVOLUT R TRANSCATHETER AORTIC VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
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Model Number EVOLUTR-34-US |
Device Problems
Unintended Collision (1429); Perivalvular Leak (1457); Difficult or Delayed Activation (2577); Device Dislodged or Dislocated (2923)
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Patient Problems
Low Blood Pressure/ Hypotension (1914); Valvular Insufficiency/ Regurgitation (4449)
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Event Date 12/09/2021 |
Event Type
Injury
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Manufacturer Narrative
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Product analysis: the valve was discarded by the customer; therefore, no product analysis can be performed. conclusion: without return of the product, no definitive conclusions could be drawn regarding the clinical observation.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, the valve was deployed at 4 millim eters (mm) on the non-coronary cusp (ncc).Upon full deployment, the valve dove slightly by approximately 2 mm.The nose cone and dcs were removed without issue.When the large sheath access site was beginning to be closed by the non-medtronic closure system, the pressure dropped significantly.Echocardiogram showed that the valve moved significantly ventricular.The waist of the valve was at the level of the annulus.Significant paravalvular leak (pvl) was observed and the mitral valve was being impinged upon by the dislodged transcatheter bioprosthetic aortic valve.The aortic valve was snared up slightly to improve hemodynamics.The valve was explanted, and a non-medtronic surgical aortic valve was implanted.No additional adverse patient effects were reported.
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Manufacturer Narrative
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Additional information was received that the paravalvular leak (pvl) following the dislodgment towards the ventricle was severe pvl.It was reported that the patient had a larger annulus, with a perimeter of 98 mm, aortic insufficiency and an left ventricular assist device (lvad), all of which contributed to the dislodgement.No additional adverse patient effects were reported.Updated b5.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: review of the device history record for this device found it was built to specification and met all final inspection and acceptance criteria.No issues noted that would have impacted this event.No images of the implantation procedure or the implanted valve were available for medtronic review and the valve was not returned to medtronic.Therefore, product analysis could not be performed.Potential factors that can influence a dislodged valve include tension applied on the delivery catheter system (dcs) during positioning, calcification levels in the native vessel, compliance of the aorta and native vessels, and a number of others.It was reported that the patient had a larger annulus, with a perimeter of 98 millimeters (mm), aortic insufficiency and a left ventricular assist device (lvad), all of which contributed to the dislodgement.However, with the information available, a conclusive root cause could not be determined.Dislodge events are typically not related to a device malfunction.Mitral valve interaction is a potential adverse event associated with the implantation of the evolut valve and it can be attributed to factors such as valve position and implant depth where the depth can impinge on the mitral valve function or damage the mitral valve.It was reported that echocardiogram showed that the valve moved significantly ventricular.Although this was a likely contributing cause, this could not be confirmed by medtronic with the information available and a conclusive root cause could not be determined.Paravalvular leak (pvl) can be caused by a variety of factors, including valve positioning, patient anatomy, or presence of pre-existing patient conditions.With the information available a conclusive root cause could not be determined, but the dislodgement was a likely contributing cause.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.With the information available, a conclusive cause could not be determined but severe pvl was a likely contributing cause.There was no information to suggest a device quality deficiency that may have caused or contributed to this event.Updated data: g1, h6 method, result, conclusion code.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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