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); Material Separation (1562); Difficult to Open or Close (2921); Noise, Audible (3273)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/14/2022 |
Event Type
malfunction
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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.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 implant of this transcatheter bioprosthetic valve, the valve was initially placed too low, and was recaptured.During the initial deployment attempt a lot of tension was reported within the system.During the first recapture, it was reported that it was not possible to recapture the valve into the capsule.A capsule separation was reported.The capsule re-sheathed approximately one-third of the valve.The delivery catheter system (dcs) started clicking in the handle and it was reported the capsule stopped responding.The physician used the "slider" and with a lot of force, was able to close the catheter a bit, and then close then recapture the valve as normal, using the handle.The valve was withdrawn from the patient.The valve and dcs were replaced.The physician reported that the dcs was rotated inside the patient to achieve commissural alignment.Of note, no loading difficulties or misload were reported.No adverse patient effects were reported.
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Manufacturer Narrative
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Conclusion: the subject dcs was discarded by the customer and as such no analysis could be performed.Procedural images were not provided for review.The reported event indicates that the valve was initially placed too low and was recaptured.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.Positioning difficulties do not typically indicate a device malfunction or a failure to meet manufacturing specifications.During the first recapture, it was reported that it was not possible to recapture the valve into the capsule.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.A capsule separation was reported.The capsule re-sheathed approximately one-third of the valve.The delivery catheter system (dcs) started clicking in the handle and it was reported the capsule stopped responding.Capsule separation occurs due to excessive compressive forces applied to the capsule.Forces in the system is a cumulative effect that may be increased by factors such as tortuous anatomy and load quality.A device history record (dhr) review was performed on the dcs and there were no correlations / issues identified regarding manufacturing.The device was manufactured per approved and released manufacturing processes and the device met all applicable manufacturing specifications prior to release for distribution.The dhr review did not show any findings related to this event.There is no information to suggest a device malfunction or a failure to meet manufacturing specifications.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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