MEDTRONIC HEART VALVES DIVISION EVOLUT PRO PLUS VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
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Model Number EVPROPLUS-34 |
Device Problem
Structural Problem (2506)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/15/2023 |
Event Type
malfunction
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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 has requested additional information pertaining to this reportable event.If additional reportable information is received, a supplemental report will be submitted.Select patient information cannot be included in regulatory report due to regional privacy regulations.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 prior to the attempted implant of this transcatheter bioprosthetic valve, the valve was loaded and the load was verified.During attempted implant, at 80% deployment, an infold was observed.The valve was recaptured and withdrawn from the patient.A new valve and delivery catheter system (dcs) were used to complete the procedure.It was reported that the procedure took longer than expected.No adverse patient effects were reported.
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Manufacturer Narrative
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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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Event Description
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Additional information was received which reported that a pre-implant balloon aortic valvuloplasty (bav) was performed using a 25 mm zmed ii balloon with manual/hand inflation.The infold was first noted on the initial deployment attempt.According to the physician, calcification possibly contributed to the infold.The calcification score was 5000.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: twenty-three media files were submitted to medtronic for review of the event.The executive summary was not provided for anatomical review.A fluoroscopic valve load inspection was performed in which a misload is evident by an inflow crown overlap involving four nodes.Per medtronic best practices, overlap prior to node four is considered a good load.Overlap at node four and beyond is considered a misload, thus the valve and delivery catheter system (dcs) should be discarded, and a new valve should be loaded onto a new dcs.However, a misload was not recognized and the valve was attempted to be deployed after a pre-implant balloon aortic valvuloplasty (bav) was performed.An infold is visible at 80%, which is characterized by an inward fold or crease in the valve.Infolding could occur due a misloaded valve, anatomical characteristics such as calcium, and recaptures.According to medtronic best practices, if an infold is identified, the valve should be recaptured, removed from the body, and discarded.New sterile components must be used.The infolded valve was recaptured, removed from the body, and deployed on the sterile field to confirm the infold.A new valve was loaded onto a new delivery catheter system and a good load was confirmed under fluoroscopy.The valve was successfully deployed without infolding.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.Infolding events are typically related to patient anatomical factors (i.E., calcification level, left ventricular outflow tract (lvot) anomalies, compliance of the annulus, bicuspid valve, etc.) and/or procedural factors (i.E., pre-case planning, sizing, loading, user technique, etc.).Additionally, the valve frame is constructed with nitinol and the latticed strut design allows the valve to be compressed and loaded into the delivery system.During either the loading or deploying/recapturing process, the struts may cross over and catch on each other while being compressed, and potentially cause infolding.It was reported that the patient's calcification possibly contributed.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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