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

Model Number EVOLUTPRO-26-US

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

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

Event Date 02/08/2023

Event Type  Injury  

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.

Event Description

Medtronic received information that during implant of this transcatheter bioprosthetic valve, the pre-operative computed tomography (ct) found that the valve leaflets were severely calcified and adhered, and the shortest diameter of the valve area was only 11.7mm, and the patient's valve annulus was 20.8mm, therefore a 26 mm valve was selected.A pre-implant balloon aortic valvuloplasty (bav) was performed using a 20 mm non-medtronic numed balloon.The shape of balloon expansion showed obvious "waist without leakage".The valve was fully deployed, however the shape of the "lower end" of the valve was not fully expanded and was severely stressed due to the calcification present.The valve dislodged.It was reported that according to the physician, the patient's annulus had severe calcification and the valve orifice was small, resulting in the valve being squeezed.The upper and lower forces were unbalanced according to the physician, and the force was greater at the lower end, eventually causing the valve to dislodge into the ascending aorta.A smaller, 23 mm transcatheter was implanted successfully.The procedure was completed without any further impact to the patient.No additional adverse patient effects were reported.

• Brand Name: EVOLUT PRO 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: 16375489
• MDR Text Key: 309529373
• Report Number: 2025587-2023-00521
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00763000017828
• UDI-Public: 00763000017828
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Report Date: 02/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: EVOLUTPRO-26-US
• Device Catalogue Number: EVOLUTPRO-26-US
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/08/2023
• Initial Date FDA Received: 02/14/2023
• Date Device Manufactured: 03/06/2022
• 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