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

Model Number EVPROPLUS-26

Device Problems Difficult or Delayed Positioning (1157); Fracture (1260); Material Invagination (1336); Material Separation (1562)

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

Event Date 02/26/2024

Event Type  malfunction  

Manufacturer Narrative

Continuation of d10:  product id l-evprop23-29 (lot: 0011837018); product type: 0195-heart valves; implant date ; explant date section d references the main component of the system.Other medical products in use during the event include: brand name evolut pro plus dcs; product id d-evprop23-29 (lot: 0011648150); product type: 0195-heart valves; implant date ; explant date 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 valve was initially released up to 80%, however the team elected to perform recapture to improve the position of the valve.The valve was released to 80% a second time, this time infolding was observed.The valve was recaptured and withdrawn.Upon removal of the valve from the delivery catheter system (dcs), a rupture occurred.The entire system was replaced.The replacement valve was implanted without issues.No adverse patient effects were reported.

Manufacturer Narrative

Updated: b5 and 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.

Event Description

Additional information was received indicating that there was no unusual resistance felt while loading the valve and a misload was not identified.It was reported that a procedural delay occurred due to the infold as it took time to withdraw the first system and load the second system.It was also reported that the patient's annular calcification contributed to the infold.Additionally, it was confirmed that the "rupture" (frame stent fracture) had occurred with the valve, not the dcs.

Manufacturer Narrative

Conclusion: the device history record was reviewed and showed this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.The valve was not returned to medtronic for analysis.Images were submitted to medtronic for review.The excerpt of the image subject matter expert (sme) review report follows: intra procedural fluoroscopic images were provided for review of the event description.Patient¿s executive summary was provided for anatomical review.Patient annulus perimeter measured 71.8 millimeter (mm) with a perimeter derived diameter of 22.9mm suggesting a 26mm evolut.It was reported that an infolded occurred during valve deployment.However, the images provided do not show evidence of an infold.Rather, the valve appeared to be under expanded versus infolded.It was reported that a rupture occurred while attempting to remove the valve from the delivery catheter system; however, there are no images of the catheter rupture.A new valve and delivery catheter system were used and successfully implanted.Of note, as stated in the instructions for use (ifu), if a bioprosthesis and catheter have been removed from a patient, dispose of both the bioprosthesis and catheter; do not attempt to reuse either component.Both the bioprosthesis and catheter must be replaced with new sterile components.Infolding events are typically related to patient anatomical factors (i.E., calcification level, left ventricular outflow tract (lvo t)anomalies, compliance of the annulus, bicuspid valve, etc.) and/or procedural factors (i.E., pre-case planning, sizing, loading, user technique, etc.).Additionally, the valve frame is constructed with nitinol and the latticed strut design allows the valve to be compressed and loaded into the delivery system.During either the loading or deploying/recapturing process, the struts may cross over and catch on each other while being compressed, and potentially cause infolding.As reported, the patient's annular calcification contributed to the infold.However, conclusive cause could not be determined from the limited information available.The valve was recaptured and withdrawn.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.Loading of the valve is a process in which the outcome is highly dependent on the operator experience and technique; the evolut system ifu contains instructions to use the integrated loading bath which features a mirror to ensure that all bioprosthesis outflow struts are symmetrical and captured in the capsule during loading and to aid in accurate placement of the transcatheter aortic valve (tav) frame paddles during loading.In addition, the ifu instructs to visually and tactilely inspect the capsule for a misloaded bioprosthesis.In this case, frame stent fracture was reported to have occurred upon removal of the valve from the delivery catheter system (dcs).The entire system was replaced.The replacement valve was implanted without issues.No adverse patient effects were reported.Based on the limited information available, a conclusive root cause could not be determined but the loading process may have been a contributing cause.There is no information to suggest a device quality deficiency that may have caused or contributed to this e vent.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• 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: 18799372
• MDR Text Key: 337514599
• Report Number: 2025587-2024-01238
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: AR
• 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: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EVPROPLUS-26
• Device Catalogue Number: EVPROPLUS-26
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2024
• Date Device Manufactured: 07/14/2023
• 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 Age: 78 YR
• Patient Sex: Female
• Patient Weight: 80 KG