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

Model Number MDT-TRANS VALVE

Device Problems Fracture (1260); Perivalvular Leak (1457); Patient Device Interaction Problem (4001); Migration (4003); Device Stenosis (4066); Central Regurgitation (4068)

Patient Problems Atrial Fibrillation (1729); Stroke/CVA (1770); Non specific EKG/ECG Changes (1817); Endocarditis (1834); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Myocardial Infarction (1969); Pulmonary Valve Stenosis (2024); Tachycardia (2095); Thrombosis/Thrombus (4440); Heart Failure/Congestive Heart Failure (4446); Valvular Insufficiency/ Regurgitation (4449); Aortic Valve Insufficiency/ Regurgitation (4450); Pulmonary Valve Insufficiency/ Regurgitation (4452)

Event Date 09/25/2023

Event Type  Injury  

Event Description

Literature was reviewed regarding one-year outcomes for harmony transcatheter pulmonary valve clinical trial participants.The study population included 87 patients with a mean age of 29 years who were predominantly male.  all patients were implanted with a medtronic harmony transcatheter pulmonary bioprosthetic valve.  among all patients adverse events included: stent fracture, thrombosis requiring anticoagulation therapy, ventricular tachycardia, moderate pulmonary regurgitation, severe paravalvular leak, valve migration, stenosis, and reintervention.  no further information was provided pertaining to medtronic products.

Manufacturer Narrative

Citation: gillespie et al.1-year outcomes in a pooled cohort of harmony transcatheter pulmonary valve clinical trial participants.Jacc cardiovasc interv.2023 aug 14;16(15):1917-1928.Doi: 10.1016/j.Jcin.2023.03.002.Epub 2023 may 17.Earliest date of publication used for date of event.No unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.Without return of the product no definitive conclusion can be made regarding the clinical observations.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.

Manufacturer Narrative

***correction: due to a processing error the initial mdr# 2025587-2024-00874 submitted on feb 14, 2024 contained an incorrect article and associated content.The incorrect article by gillespie et al was previously reviewed in another system record, and deemed dup licate information as more specific adverse event data from the medtronic-sponsored study were reported at the individual patient level.This supplemental mdr is based on the correct article authored by mesnier et al, and is entitled ¿cardiac death after transcatheter aortic valve replacement with contemporary devices¿.*** citation: mesnier et al.Cardiac death after transcatheter aortic valve replacement with contemporary devices.Jacc cardiovasc interv.2023 sep 25;16(18):2277-2290.Doi: 10.1016/j.Jcin.2023.07.015.Earliest date of publication used for date of event.No unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.Without return of the product no definitive conclusion can be made regarding the clinical observations.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Literature was reviewed regarding a multi-center study on cardiac death after transcatheter aortic valve replacement (tavr).The study population included 5,421 patients with a mean age of 80.5 years who were predominantly male.Multiple manufacturer¿s devices were implanted in the study population; an undisclosed number of patients were implanted with a medtronic evolut r, evolut pro or evolut pro+ bioprosthetic valve.Deaths occurred in the study population; however, there was no statement establishing a causal or contributory relationship between medtronic product and the deaths.Among all patients adverse events included: congestive heart failure, stroke, myocardial infarction, endocarditis, vascular complication, bleeding complication, acute kidney injury, infection, moderate to severe aortic regurgitation, atrial fibrillation, periprocedural ventricular arrythmias, arrhythmia requiring permanent pacemaker implant, and valve-in-valve implant.No further information was provided pertaining to medtronic products.

• Brand Name: MEDTRONIC TRANSCATHETER 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: 18706627
• MDR Text Key: 335405260
• Report Number: 2025587-2024-00874
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/08/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MDT-TRANS VALVE
• Device Catalogue Number: MDT-TRANS VALVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2024
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 81 YR
• Patient Sex: Male