MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION EVOLUT PRO PLUS VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV

Model Number EVPROPLUS-29

Device Problems Difficult or Delayed Activation (2577); Device Dislodged or Dislocated (2923); Patient Device Interaction Problem (4001)

Patient Problems Low Blood Pressure/ Hypotension (1914); Obstruction/Occlusion (2422); Low Cardiac Output (2501)

Event Date 11/07/2022

Event Type  Injury  

Event Description

Medtronic received information that prior to the implant of this transcatheter bioprosthetic valve, the pre-case planning and computed tomography (ct) measurements indicated that this patient was sized for a size 29 mm valve.A pre-implant balloon aortic valvuloplasty (bav) was performed using a 20 mm non-medtronic (vacs) balloon.The first deployment attempt showed that the valve was under-expanded, therefore the valve was recaptured.The second deployment attempt resulted in an adequate result, and the valve was deployed.However, the valve remained slightly under-expanded.The post implant echocardiogram showed no residual regurgitation and no gradient.The patient was hemodynamically unstable, however.The patient's ejection fraction and blood pressure were very low.The implant team assessed for a coronary occlusion.After a couple of minutes, the team realized that the valve had dislodged and was stuck intra-annular.Re-animation was performed and the patient was intubated.Advanced cardiovascular life support (acls) was performed.Th e patient was transferred to emergency surgery.The transcatheter bioprosthetic valve was explanted and a 21 mm medtronic surgical valve (hancock) was implanted.The patient was able to be extubated and was reported to have been in good condition.No additional adverse patient effects were reported.

Manufacturer Narrative

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.

Manufacturer Narrative

Conclusion: the valve was discarded by customer, so it was not returned to medtronic for product analysis.Images were submitted to medtronic for review.The excerpt of the image subject matter expert (sme) review report follows: a complete report with the computed tomography (ct) measurements was requested but was not made available.The annulus perimeter was 75.6 mm suggesting a 29 mm evolut valve per sizing matrix.The valve was calcified and a pre-implant balloon aortic valvuloplasty (bav) was performed.An image showed a fully deployed evolut valve with a constrained inflow and a depth of 5 mm at the left coronary cusp (lcc).Another image showed a more expanded inflow, and an aortography was performed where coronary filling was not visualized.Additionally, the evolut valve appeared to have dislodged into a sub-annular position.As coronary filling is not visualized, coronary re-access efforts are warranted.A catheter can be seen positioned under the evolut valve frame, and contrast is injected directly into the left coronary cusp (lcc), filling the left coronary artery.Although the coronary artery can be visualized, this is not an accurate way to assess post coronary artiereis post transcatheter aortic valve replacement.Per medtronic best practices, when re-accessing coronaries through an evolut valve frame, it is recommended to approach coaxially and to advance to the frame waist.In this case, it appears that the dislodgement of the evolut valve into a sub-annular position resulted in coronary obstruction.The reason for the dislodgement remains unclear.The reported event indicates that the first deployment attempt showed that the valve was under-expanded, therefore the valve was recaptured.The second deployment attempt resulted in an adequate result, and the valve was deployed.However, the valve remained slightly under-expanded.Per the device instructions for use (ifu), if 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.The event also indicates that the patient was hemodynamically unstable.Hemodynamic instability can be the result of effects such as low cardiac output and hypotension, which are known potential adverse events per the device ifu.It was also reported that the patient's ejection fraction (ef) and blood pressure were very low.Low ejection fraction can be caused by a variety of factors, including patient anatomy, or presence of pre-existing patient conditions.Hypotension is a known potential adverse effect per the device 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.It was further reported that after a couple of minutes, the team realized that the valve had dislodged and was stuck intra-annular.Potential factors that can influence a dislodged valve include tension applied on the delivery catheter system (dcs) during positioning, calcification levels in the native vessel, compliance of the aorta and native vessels, and a number of others.In this case, a pre-implant balloon aortic valvuloplasty (bav) was performed using a 20 mm non-medtronic (vacs) balloon.Dislodge events are typically not related to a device malfunction.The device history record and frame record were reviewed and showed that this device met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.There is no information to suggest a device quality deficiency that may have caused or contributed to this event.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.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.

• Brand Name: EVOLUT PRO PLUS VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIV
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 15794685
• MDR Text Key: 303626576
• Report Number: 2025587-2022-03187
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/06/2023
• Device Model Number: EVPROPLUS-29
• Device Catalogue Number: EVPROPLUS-29
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2023
• Date Device Manufactured: 08/06/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Sex: Female