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

Model Number EVOLUTR-29

Device Problems Device Dislodged or Dislocated (2923); Activation Problem (4042)

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

Event Date 02/02/2023

Event Type  Injury  

Event Description

Medtronic received information that immediately following the implant of this transcatheter bioprosthetic valve, the valve was reported to be slightly under-expanded.The physician pulled the pigtail catheter out of the ventricle, and the pigtail catheter caught on the strut of the valve, causing the valve to dislodge to the ascending aorta.The valve was then relocated using two snares to the descending aorta.A non-medtronic (edwards) valve was ultimately implanted.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: thirteen fluoroscopic images were submitted to medtronic for review of the event.The patient executive summary was not provided for anatomical review.Fluoroscopy of the valve load was free from overlap past the fourth node and would be considered an adequate load.Imaging of the pigtail catching on the strut of the valve was not provided for review.There is no imaging of the medtronic bioprosthetic valve being deployed fully in the annulus.Imaging shows the medtronic bioprosthetic valve at 80%.There does appear to be a significant gap between valve frame and the left coronary cusp (lcc).It is difficult to demonstrate the paravalvular leak (pvl) on a static image.Annular perimeter not provided to know if adequate size valve was selected for deployment.The medtronic bioprosthetic valve is shown to be dislodged in the ascending aorta and appears to be ¿dancing¿ around and not secure to the vessel wall.It is then snared into the descending aorta with double snares.Subsequently, there is a non-medtronic bioprosthetic valve being deployed and a space between the lcc and the bioprosthetic valve can be seen.It appears that the medtronic bioprosthetic valve could have been undersized.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.With the limited information available and without a returned valve for analysis, a conclusive root cause for the under expansion cannot be determined.In this event, neither a pre-implant balloon aortic valvuloplasty (bav) or a post-implant bav were reported for this valve.Per the device instructions for use (ifu), in the event that 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 dilation.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.Potential factors that can influence a dislodge include tension applied on the delivery catheter system (dcs) during positioning, calcification levels and compliance of the native anatomy, and user technique.Dislodge events are typically not related to a device malfunction.In this event, it was reported that the pigtail catheter caught on the strut of the valve and caused it to dislodge.However, with the limited information, we are unable to conclusively determine the cause for this report.Per the image review, the under expansion and subsequent dislodgement were potentially due to valve undersizing.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: 16383390
• MDR Text Key: 309635631
• Report Number: 2025587-2023-00549
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/02/2023
• Device Model Number: EVOLUTR-29
• Device Catalogue Number: EVOLUTR-29
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2023
• Date Device Manufactured: 11/02/2022
• 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