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

Model Number EVOLUTR-26

Device Problem Fracture (1260)

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

Event Date 07/21/2023

Event Type  malfunction  

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, the device was returned via ups inside its original product packaging.All leaflets were flexible.Surface peeling was found on the inflow, fibrous, side of a leaflet.A tear was found on the free margin of one leaflet.As received, all leaflets were in the closed position with a gap at the point of coaptation.All commissures were intact.The outflow frame exhibited an elliptical and deformed appearance.Visual inspection revealed multiple kinked struts and fractures on the cells lateral to the c paddle.The fracture faces and kinked struts were observed.Released product management engineering was notified for further investigation.Conclusion: the investigation is in progress.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.

Event Description

Medtronic received information that during loading of this transcatheter bioprosthetic valve, the health care professional (hcp) noticed a bending in the capsule while starting the crimping by rotating the delivery catheter system (dcs) deployment knob.The hcp stopped the crimping and wanted to get the valve out of the dcs to start the loading process from the beginning.The hcp attempted to rotate the dcs deployment knob in the other direction but was not able to.After a while, the hcp used "a lot of force" to pull the valve out of the dcs.After the valve was pulled out of the dcs, the frame was noted to be completely damaged.According to the hcp, everything was fine when the crimping was started: all paddles in the pockets, no overlap of struts, stylet inside the dcs nose cone.A different valve and dcs were used for implant.No adverse patient effects were reported.

Manufacturer Narrative

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: 17956418
• MDR Text Key: 325908173
• Report Number: 2025587-2023-04190
• 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: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EVOLUTR-26
• Device Catalogue Number: EVOLUTR-26
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1