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

Model Number EVOLUTR-23

Device Problems Perivalvular Leak (1457); Patient Device Interaction Problem (4001)

Patient Problems Stroke/CVA (1770); Non specific EKG/ECG Changes (1817); Hemorrhage/Bleeding (1888); Myocardial Infarction (1969); Cardiac Tamponade (2226); Cardiovascular Insufficiency (4445); Heart Failure/Congestive Heart Failure (4446); Valvular Insufficiency/ Regurgitation (4449)

Event Date 02/21/2024

Event Type  Injury  

Event Description

Literature was reviewed regarding the effect of aortic angulation on clinical outcomes of patients undergoing transcatheter aortic valve replacement (tavr).The study population included 264 patients with a mean age of 78.9 years who were predominantly female. all patients were implanted with a medtronic evolut r bioprosthetic valve.  seventeen in-hospital deaths occurred in the study population; the authors attributed those deaths to ¿procedural and/or cardiac causes."  no further details were provided on those deaths.  additional deaths occurred in the study population during the follow-up period; however, there was no statement establishing a causal or contributory relationship between medtronic product and the deaths. among all patients adverse events included: arrhythmia requiring permanent pacemaker implant, stroke, tamponade, acute kidney injury, bleeding and/or vascular complication, coronary obstruction, moderate to severe paravalvular leak, myocardial infarction, and congestive heart failure.  no further information was provided pertaining to medtronic products.

Manufacturer Narrative

Citation: aktan et al.The effect of aortic angulation on clinical outcomes of patients undergoing transcatheter aortic valve replacement.Braz j cardiovasc surg.2024 mar-apr; 39(2): e20220436.Doi: 10.21470/1678-9741-2022-0436.Published online 2024 feb 21.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.

• 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: 18980851
• MDR Text Key: 338626859
• Report Number: 2025587-2024-01912
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EVOLUTR-23
• Device Catalogue Number: EVOLUTR-23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/19/2024
• 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: 79 YR
• Patient Sex: Female