MEDTRONIC HEART VALVES DIVISION EVOLUT PRO PLUS VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
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Model Number EVPROPLUS-26US |
Device Problems
Degraded (1153); Gradient Increase (1270); Material Too Rigid or Stiff (1544); Patient-Device Incompatibility (2682)
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Patient Problem
Thrombosis/Thrombus (4440)
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Event Date 12/10/2021 |
Event Type
Injury
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Manufacturer Narrative
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Product analysis: the device remains implanted and no procedural images were submitted for review; therefore, no product analysis can be performed.Conclusion: without the return of the product, no definitive conclusion can be made 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 approximately three months, fourteen days following the implant of this transcatheter bioprosthetic valve, the patient was admitted with heart failure and a gradient of 60-70 millimeter (mm) of mercury (hg) was noted.An echocardiogram revealed thrombus on the valve leaflets.Anticoagulant medication was provided for five days with no change in the gradient.It was believed that the leaflets were calcified because the anticoagulants did not help.Subsequently, approximately six days following admission, a second non-medtronic transcatheter valve was implanted and the gradient decreased to 12 mm hg.No additional adverse patient effects were reported.
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Manufacturer Narrative
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Conclusion: the device history record was reviewed and showed that this device met all manufacturing specifications for final product released for distribution.No issues were identified that would have impacted this event.High gradients increase over time are typically related to patient factors such as, but not limited to, thrombus formation, calcification, patient pressures, and/or anatomical left ventricular outflow tract (lvot) obstruction, etc.It was reported that an echocardiogram revealed a thrombus on the valve leaflets.A number of factors can affect the creation of thrombus, including medications, peri-procedural injury, and pre-existing patient conditions, and its presence and rate of formation is largely dependent on patient condition.It is known that thrombus formation may lead to decreased leaflet mobility leading to valve high gradient, which might had occurred in this event.However, with the information available, the cause of the thrombus formation cannot be determined.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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Manufacturer Narrative
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Additional information was received that the final implant depth of the valve on the non-coronary cusp (ncc) and left coronary cusp (lcc) was 3-5 mm.Anticoagulation therapy was provided and antiplatelet therapy (aspirin and plavix) was used following the valve implant.The non-medtronic valve was implanted valve-in-valve.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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