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

Model Number EVOLUTFX-29

Device Problems Inadequacy of Device Shape and/or Size (1583); Patient Device Interaction Problem (4001)

Patient Problem Non specific EKG/ECG Changes (1817)

Event Date 02/26/2024

Event Type  Injury  

Event Description

Medtronic received information that prior to the implant of this 26mm transcatheter bioprosthetic valve, a pre-implant balloon valvuloplasty was not performed.During implant, sizing issue was noted.Subsequently, an unspecified heart block was reported.It was noted that due to the lack of calcium to anchor the 26mm valve, the team made a decision to upsize to a 29mm valve for more radial expansion for anchoring.A larger 29mm valve was implanted successfully.Approximately 20 minutes procedural delay occurred as a result of the sizing issue.No additional adverse patient effects were reported.

Manufacturer Narrative

H6: the codes present in section h6 correspond to components/products that comprise the reported event.Continuation of d10: product id: d-evolutfx-2329 (lot: 0012041615); product type: 0195-heart valves.Product id: evolutfx-29 (serial: (b)(6); product type: 0195-heart valves; implant date: (b)(6) 2024.Medtronic has requested additional information pertaining to this reportable event.If additional reportable information is received, a supplemental report will be submitted.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.

Event Description

Medtronic received information that prior to the implant of this 26mm transcatheter bioprosthetic valve, a pre-implant balloon valvuloplasty was not performed.During implant, sizing issue was noted.Subsequently, an unspecified heart block was reported.It was noted that due to the lack of calcium to anchor the 26mm valve, the team made a decision to upsize to a 29mm valve for more radial expansion for anchoring.A larger 29mm valve was implanted successfully.Approximately 20 minutes procedural delay occurred as a result of the sizing issue.No additional adverse patient effects were reported.Additional information was received which confirmed the heart block was an alternating bundle branch block.Subsequently, a permanent pacemaker was implanted two days later.

Manufacturer Narrative

Updated data: b2.Outcome attributed updated b5.Second paragraph added d4.Device model #, catalog #, expiration date, serial number, unique identifier #, and implanted date updated h6.Method code updated 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 FX 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: 18825622
• MDR Text Key: 336767125
• Report Number: 2025587-2024-01334
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00763000370701
• UDI-Public: 00763000370701
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EVOLUTFX-29
• Device Catalogue Number: EVOLUTFX-29
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/04/2024
• Date Device Manufactured: 08/12/2023
• 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
• Treatment: SEE H11...
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 84 KG