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); Central Regurgitation (4068)

Patient Problems Atrial Fibrillation (1729); Stroke/CVA (1770); Non specific EKG/ECG Changes (1817); Hemorrhage/Bleeding (1888); Valvular Insufficiency/ Regurgitation (4449); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 10/14/2022

Event Type  Injury  

Manufacturer Narrative

Citation: kolar et al.Minimally invasive surgical aortic valve replacement versus transfemoral transcatheter aortic valve implantation in low-risk octogenarians: observational, retrospective and single-center study.Wien klin wochenschr.2023 dec;135(23-24):703-711.Doi: 10.1007/s00508-022-02094-z.Epub 2022 oct 14.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 minimally invasive surgical aortic valve replacement versus transfemoral transcatheter aortic valve implantation in low-risk octogenarians.The study population included 301 patients who were predominantly female with a mean age of 84 years.  multiple manufacturer¿s devices were implanted in the study population; 74 patients were implanted with a medtronic evolut r 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: new onset atrial fibrillation, arrhythmia requiring permanent pacemaker implant, stroke, paravalvular leak, severe aortic regurgitation, major bleeding, and acute kidney injury.  no further information was provided pertaining to medtronic products.

• 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: 19169285
• MDR Text Key: 340899280
• Report Number: 2025587-2024-02502
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: SI
• 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: 04/23/2024

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 Model Number: EVOLUTR-23
• Device Catalogue Number: EVOLUTR-23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/15/2024
• Initial Date FDA Received: 04/23/2024
• 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): Required Intervention; Life Threatening; Hospitalization
• Patient Age: 84 YR
• Patient Sex: Female