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

Model Number EVOLUTR-34

Device Problems Device Dislodged or Dislocated (2923); Activation Failure (3270)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/16/2023

Event Type  Injury  

Manufacturer Narrative

Product analysis: the device remains implanted, therefore no product analysis can be performed.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.

Event Description

Medtronic received information that during implant of this transcatheter bioprosthetic valve, the was not stable and did not stay in position due to calcium only on the non-coronary cusp (ncc) sinus leaflet.The "big nodule" dislodged the valve and into the left ventricle.After the final release of the valve, the valve dislodged into the left ventricle requiring a second valve to be implanted.No additional adverse patient effects were reported.

Event Description

Medtronic received information that during implant of this transcatheter bioprosthetic valve, the was not stable and did not stay in position due to calcium only on the non-coronary cusp (ncc) sinus leaflet.The "big nodule" dislodged the valve and into the left ventricle.After the final release of the valve, the valve dislodged into the left ventricle requiring a second valve to be implanted.No additional adverse patient effects were reported.Additional information was received which reported that a pre-implant balloon aortic valvuloplasty (bav) was not performed.The "big nodule" referred to calcium on the ncc.It was reported that a post implant bav was performed to improve valve expansion.The patient was rapid paced during the post implant bav at 170 beats per minute (bpm).No additional adverse patient effects were reported.

Manufacturer Narrative

Updated data: b5 - event description h6 - device code additional code (a150101) added additional codes - img component code updated from g07001 to g04027 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

Additional information was received that the post balloon aortic valvuloplasty (bav) did not cause the valve to dislodge.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: case cines and computed tomography (ct) images were submitted to medtronic for review.The valve appears to be loaded correctly in accordance with instructions for use (ifu) and best practices.Although ct is considered the best modality for assessing the degree of calcification, the calcium nodule that is mentioned in the report is visible on angiography.Imaging shows the initial process of valve deployment.All appears to be in line with best practices for the initiation of valve deployment and the steps that follow.Although there is no cine evidence of the moment, the valve dislodged into the ventricle.Imaging confirms the result and shows the valve at a very deep implant position of around 15mm at 80% deployment.This deployment attempt was recaptured and re-attempted with the same valve and delivery system.There were another three deployment attempts with 4 recaptures.Imaging shows the 80% valve assessment of deployment 2 and 3.Both resulted in similar outcomes to the initial deployment with an implant depth of greater than 10mm.Imaging shows the 80% deployment evaluation of the 4th deployment attempt.Implant depth is greater than 6mm.According to the report and confirmed by the sequence of case cines, this deployment attempt was released.This is against best practices wh ich state if valve placement is outside of 1-5mm deployment range, it should be recaptured.Imaging shows a final release angiography where the valve is sitting deep into the left ventricular outflow tract (lvot) at an implant depth of more than 12mm.There is no evidence of the final release, but the image shows the outcome.Imaging shows the second valve being deployed, and final release after assessment.The first valve is left in situ while a second valve is implanted.Final release shows the second valve to be implanted higher than the first.There is also evidence of paravalvular leak (pvl).The set of valves was post-dilated.The second image shows a final case angiography with evidence of pvl.The device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.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, and compliance of the aorta and native vessels.In this event, it was reported that a nodule of calcification on the non-coronary cusp (ncc) caused the valve to dislodge.Per the image review, the deep implant positioning may also have been a contributing factor.However, with the limited information available, a root cause for the dislodgement could not be conclusively determined.A conclusive root cause for the reported under expansion could not be determined either, however, the patient's calcification may have been a contributing factor.This event does not indicate device misuse or malfunction.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 R TRANSCATHETER AORTIC 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: 16415539
• MDR Text Key: 309946850
• Report Number: 2025587-2023-00640
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/15/2023
• Device Model Number: EVOLUTR-34
• Device Catalogue Number: EVOLUTR-34
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2023
• Date Device Manufactured: 07/15/2022
• 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
• Patient Sex: Male