MEDTRONIC HEART VALVES DIVISION ENVEO PRO DELIVERY SYSTEM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
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Model Number ENVPRO-16 |
Device Problems
Difficult or Delayed Positioning (1157); Difficult to Open or Close (2921); Device Dislodged or Dislocated (2923); Activation Failure (3270)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/05/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: e volutr-34, serial/lot #: (b)(6) ubd: 10-jun-2024, 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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Medtronic received information that during the attempted implant of this transcatheter bioprosthetic valve, a pre-implant balloon aortic valvuloplasty (bav) was performed.Following, the valve was inserted, however the inflow of the valve did not open when deployed to 60%.It was noted that the minimum diameter was 22 mm and the pre implant balloon was a 22 mm balloon.The valve dislodged and was recaptured.Deployment began a second time, however was not in the correct position.During the third deployment attempt, the valve was not positioned correctly and the outflow of the valve did not open.Tree full recaptures were performed.Difficulty recapturing the valve was reported because the capsule of the delivery catheter system (dcs) was not responding "one to one" with the deployment knob.It was noted that the patient's native aortic valve was bicuspid type 1 and was heavily calcified -- a calcium of 3500 was reported.The valve was not implanted.No adverse patient effects were reported.
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Manufacturer Narrative
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Updated a.3b medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Manufacturer Narrative
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Conclusion: the subject delivery catheter system (dcs) was not returned to medtronic for analysis and no procedural images were provided for review.It was reported that, on the first deployment attempt, the valve dislodged.Potential factors that can influence dislodgement include tension applied on the dcs during positioning, calcification levels and shape of the native anatomy.In this case, it was noted that the patient's native aortic valve was bicuspid type 1 and was heavily calcified, which may have contributed to the dislodgement.Dislodgement events do not typically indicate a device malfunction or a failure to meet manufacturing specifications.The reported event indicates that the valve was recaptured twice due to sub-optimal positioning.Recapturing is a feature of the evolut system that allows for additional attempts at accurately positioning the valve.Various factors can affect valve positioning including patient anatomy or physician technique.In this case, it was noted that the patient's native aortic valve was bicuspid type 1 and was heavily calcified, which may have contributed to the positioning difficulties.Positioning difficulties do not typically indicate a device malfunction or a failure to meet manufacturing specifications.Difficulty recapturing the valve was reported because the capsule of the dcs was not responding "one to one" with the deployment knob.The force in the dcs when closing the capsule is cumulative and many sources may contribute to the feeling of excess tension including load quality, bends and kinks on the shaft, and tortuous anatomy.In this case, it is possible that the patient's native aortic valve was bicuspid type 1 and heavy calcification may have contributed to the difficulty recapturing the valve.There is no information to suggest that a device malfunction or a failure to meet manufacturing specifications was related to this event.The device history record was reviewed for the valve (f605680) and showed this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.Per the device instructions for use (ifu), in the event that valve function or sealing is impaired due to excessive calcification or incomplete expansion, a post-implant balloon dilation of the bioprosthesis may improve valve function and sealing.To ensure patient safety, valve size and patient anatomy must be considered when selecting the size of the balloon used for dilatation.¿ the balloon size chosen for dilatation should not exceed the diameter of the native aortic annulus.Refer to the specific balloon catheter manufacturer's labeling for proper instruction on the use of balloon catheter devices.In this case, the root cause of the frame expansion is unknown, however the patient¿s calcified anatomy is likely a contributing factor.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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