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

Model Number EVPROPLUS-34

Device Problems Material Invagination (1336); Inadequacy of Device Shape and/or Size (1583)

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

Event Date 02/22/2024

Event Type  malfunction  

Manufacturer Narrative

Continuation of d10: product id: d-evprop34, (lot: 0012033819); and product type: 0195-heart valves.Product id: l-evprop34, (lot: 0011656961); and product type: 0195-heart valves.Product id: evproplus-29, (serial: (b)(6)); and product type: 0195-heart valves.Product id: d-evprop23-29, (lot: 0011978629); and product type: 0195-heart valves.Product id: l-evprop23-29, (lot: 0012033771); and product type: 0195-heart valves; product id: elan root 25; and product type: surgical valve.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 the valve-in-valve implant of this transcatheter bioprosthetic valve into a previously implanted degenerated non-medtronic surgical valve (elan root 25), the case could be treated with both a 34 millimeter (mm) or 29 mm valve.The surgical valve degeneration of the non-medtronic valve (elan root 25) was aortic regurgitation and the physician decided to use the 34 mm valve.During the implant, while attempting to open and release the valve, infolding was observed.The infolding may have resulted from the degenerated leaflets of the surgical valve that operated dishomogeneous pressures on the stent frame.The valve was retrieved from the body and the patient remained stable.The physician's decided to use the 29 mm valve which was implanted successfully.No adverse patient effects were reported.

Event Description

Additional information was received indicating that on initial deployment with the 34 millimeter (mm) valve, before 80% deployment, the valve was determined to be too high.The valve was recaptured.On the second deployment attempt, the infold was observed.A procedural delay was reported as a result of the infold.

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 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: 18785672
• MDR Text Key: 336993635
• Report Number: 2025587-2024-01150
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EVPROPLUS-34
• Device Catalogue Number: EVPROPLUS-34
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2024
• Date Device Manufactured: 05/02/2023
• 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 Age: 80 YR
• Patient Sex: Male