MEDTRONIC HEART VALVES DIVISION EVOLUT FX VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
|
Back to Search Results |
|
Model Number EVOLUTFX-23 |
Device Problems
Difficult or Delayed Positioning (1157); Device Dislodged or Dislocated (2923)
|
Patient Problems
Bradycardia (1751); Low Blood Pressure/ Hypotension (1914)
|
Event Date 02/07/2023 |
Event Type
Death
|
Manufacturer Narrative
|
Concomitant medical products: other relevant device(s) are: product id: d- evolutfx-2329, lot#: unknown, use by date: unknown, udi#: unknown.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.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.
|
|
Event Description
|
Medtronic received information that during implant of this transcatheter bioprosthetic valve, a pre-balloon aortic valvuloplasty (bav) was performed with an 18 millimeter (mm) non-medtronic balloon.After the bav, the aortic pressure dropped to around 20 millimeters of mercury (mmhg).The valve was advanced to position and the patient was paced at 140 beats per minute (bpm).At 80% deployment, the valve was deployed too high and it was recaptured.The patient became bradycardic and the aortic pressure dropped to below 50 mmhg diastolic.The valve was repositioned and the patient was paced at 140 bpm.The valve was then deployed.A wire was introduced into the pigtail catheter to remove it from behind the valve frame.Upon removal of the catheter, the valve dislodged aortic.Another valve was prepped with a new delivery catheter system (dcs) however the patient decompensated with little pressure and was supported with temporary transvenous pacing.Cardiopulmonary resuscitation (cpr) was performed.A decision was made to add extracorporeal membrane oxygenation (ecmo) to the patient.After a period of time, the patient was pronounced deceased.
|
|
Event Description
|
Additional information was received that during the valve implant, the valve dislodged after being release from the delivery catheter system (dcs).Per the physician, the dcs did not cause the valve to dislodge and the valve did not cause or contribute to the death.
|
|
Manufacturer Narrative
|
Updated data: b5: event description, b7: relevant history, h6: method code for the concomitant product updated from b17 to b18.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.
|
|
Manufacturer Narrative
|
Section d information references the main component of the system.Other relevant device(s) are: product id d-evolutfx-2329 lot 0011507775 use by date 2024-11-15 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.
|
|
Manufacturer Narrative
|
Conclusion: a medical safety assessment was completed.Based on the information provided, it is likely that the primary event of valve dislodgment was due to the valve as it was reported it dislodged after release from the delivery catheter system.It is also likely that the initial hypotension was due to the pre-implant balloon aortic valvuloplasty.Temporary pacing, cardiopulmonary resuscitation and extracorporeal membrane oxygenation were likely initiated to treat the decompensation.No further safety assessment required, and no further action is needed as this complaint did not identify any unexpected serious adverse events.Hypotension is a known potential adverse effect per device instructions for use (ifu).It is an effect that is highly dependent on the patient's pre-procedural condition and can occur despite a normally-functioning device or model implant procedure.In this case, a conclusive cause could not be determined from the limited information available.Conduction disturbances are known potential adverse effects per the device ifu.Factors that may impact the development of conduction disturbances include depth of implant, baseline conduction defects, and anatomical considerations, but a conclusive cause could not be determined from the limited information available.Recapturing is a feature of the device 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 that a device quality deficiency 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.Updated: h6 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.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
|
|
|