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

Model Number EVOLUTFX-29

Device Problem Fracture (1260)

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

Event Date 06/26/2023

Event Type  malfunction  

Event Description

Medtronic received information that prior to the implant of this transcatheter bioprosthetic valve, the medtronic representative removed the valve from the jar using a hemostat, but "misjudged" where the outflow crown was "squeezed" and broke the outflow crown on the valve frame.No attempt was made to use the valve.A new valve was used for implant.No adverse patient effects were reported.

Manufacturer Narrative

Product analysis: the device was discarded; 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.

Manufacturer Narrative

Updated data: h6 - method, result and conclusion codes h10 - conclusion: a manufacturing team assess the allegations against the device.Based on the pictures provided and preliminary analysis, it can be concluded that complaint is confirmed for distorted valve frame.After evaluation the cause of this complaint could not be determined.As a preventive action, the complaint reported was notified to the quality inspection personnel.The review of the device history record found no abnormalities during manufacturing that would cause or contribute to the reported event.Complaints received from jan to july 2023 for the same failure mode were reviewed and showed no trends warranting escalation related to this occurrence.Assessment against the medtronic risk management file indicates that the current risk zone does not exceed the risk zone predicted in the product pfmeca; therefore, no capa will be initiated at this time.There were no adverse patient effects as a result of this incidence.Review of the complaint file indicates sufficient information was provided for completion of this investigation.Medtronic will continue to monitor for future occurrences and trends per trend analysis procedure.In addition, controls and inspections in the progressive visual inspection throughout the sewing process and valve final quality inspection, allow to detect and prevent this non-conformance.Further monitoring required.Cause not yet determined.Unable to determine cause.Loading of the valve is a process in which the outcome is highly dependent on the operator experience and technique; the evolut system instructions for use (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 fracture was reported to have occurred prior to the loading but after the valve was removed from the box.The root cause cannot be determined with information available, however the use of the hemostat on the stent is likely a contributing factor.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.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 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: 17294745
• MDR Text Key: 318983997
• Report Number: 2025587-2023-02746
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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
• Initial Date Manufacturer Received: 06/26/2023
• Initial Date FDA Received: 07/10/2023
• Supplement Dates Manufacturer Received: 08/04/2023
• Supplement Dates FDA Received: 08/30/2023
• Date Device Manufactured: 04/28/2023
• 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: 81 YR
• Patient Sex: Male
• Patient Weight: 83 KG