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

Model Number	MCS-P3-26-AOA-US
Medical Device Problem Codes	Gradient Increase (1270); Device Stenosis (4066)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); Chest Pain (1776); Dyspnea (1816); Fatigue (1849); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Medtronic received information that eight years, seven months, and twenty-three days post implant of this aortic bioprosthetic valve, the patient was evaluated for a transcatheter valve-in-valve replacement.Peak velocity measured 3.9m/s and the mean transvalvular gradient was 39mmhg via echocardiogram.The reason for evaluation was due to failed valve.No intervention or treatment was reported.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Product analysis: the device remains implanted, and no procedural images were submitted for review; 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 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.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.
Additional 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.
Event or Problem Description
Additional information was received that the mean gradient (mg) before the initial valve implant was 57mmhg and the ejection fraction (ef) was 30%.During the initial transcatheter aortic valve replacement (tavr), the first valve dislodged, and a second valve was implanted in the native annulus.Concurrently, pulmonic valvuloplasty was performed.One day post-implant, the mg across the aortic valve was 21mmhg and ef 45%.However, left ventricle systolic function has also improved considerably overnight and it contributed to the increased gradient.One-month post-implant, the mg was 12mmhg.There was no evidence of thrombus or leaflet thickening on the bioprosthetic valve.It was noted that the patient initially had a good result but now has had recurrent symptoms of fatigue, dyspnea on exertion and paroxysmal nocturnal dyspnea.The patient reported episodes of chest pain.No dizziness or syncope was noted.The patient¿s work-up showed severe bioprosthetic aortic stenosis with a valve area of 0.62cm2.The patient was scheduled for repeat tavr in approximately one month.No adverse patient effects were reported.

• Brand Name: COREVALVE TRANSCATHETER AORTIC VALVE
• Common Device Name: 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: 17994907
• Report Number: 2025587-2023-04304
• Device Sequence Number: 5884708
• Product Code: NPT
• UDI-Device Identifier: 00643169448537
• UDI-Public: 00643169448537
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P130021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/18/2017
• Device Model Number: MCS-P3-26-AOA-US
• Device Catalogue Number: MCS-P3-26-AOA-US
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2023
• Supplement Date Received by Manufacturer: 11/02/2023
• Initial Report FDA Received Date: 10/24/2023
• Supplement Report FDA Received Date: 11/09/2023
• Date Device Manufactured: 02/05/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 102 KG