MEDTRONIC HEART VALVES DIVISION ENVEO PRO DELIVERY SYSTEM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
|
Back to Search Results |
|
Model Number ENVPRO-14 |
Device Problems
Difficult or Delayed Positioning (1157); Fracture (1260)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 12/03/2019 |
Event Type
malfunction
|
Manufacturer Narrative
|
Product analysis: the device was discarded, therefore no product analysis can be performed.Conclusion: the reported event indicates that a valve recapture was attempted.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.There is no information to suggest a device quality deficiency that may have caused or contributed to this event, but the cause of the positioning difficulty could not be conclusively determined with the available evidence.Positioning difficulties do not typically indicate a device malfunction or a failure to meet manufacturing specifications.The reported event indicates that during recapture of the valve, the deployment knob (actuator) of the delivery catheter system (dcs) separated.The customer discarded the dcs and as such it could not be returned for analysis.Actuator separation is typically associated with broken or damaged snap fit tabs, either one tab or both, which hold the handle together.A capa was initiated to investigate the root cause of actuator separation events.The valve was able to be repositioned and implanted successfully.No adverse patient effects were reported.If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
Medtronic received information that during the implant of this transcatheter bioprosthetic valve, the valve was loaded properly with no stress or noises noted during loading.The fluoroscopy check did not reveal a misload.During the implant, upon the first recapture due to positioning, the blue handle broke in half at two thirds recaptured.Partial recapture allowed the valve to be repositioned and using the transparent guide under the blue handle, the valve was released.The valve was in a good position with no regurgitation or gradient reported.No adverse patient effects were reported.
|
|
Manufacturer Narrative
|
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.
|
|
Search Alerts/Recalls
|
|
|