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

Model Number EVOLUTR-23

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Stroke/CVA (1770); Non specific EKG/ECG Changes (1817); Heart Block (4444)

Event Date 01/11/2024

Event Type  Injury  

Manufacturer Narrative

Citation: damas f, nguyen trung ml, postolache a, et al.Cardiac damage and conduction disorders after transcatheter aortic valve implantation.J clin med.2024;13(2):409.Published 2024 jan 11.Doi:10.3390/jcm13020409 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 the association between aortic stenosis-related cardiac damage and conduction disorders after tran scatheter aortic valve implantation (tavi).A total of (b)(4) patients who underwent tavi with a medtronic evolut r valve were included in the study population.The authors observed (b)(4) deaths of cardiovascular cause.The circumstances or exact causes of the deaths were not disclosed, and no statement was made directly attributing the deaths to medtronic product.Other adverse outcomes included: need for permanent pacemaker implantation; new conduction disturbances (atrial fibrillation, second- or third-degree atrioventricular block, left or right bundle branch block, increased pr interval or qrs duration); and stroke.No further information pertaining to medtronic products was noted.

• 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: 18946388
• MDR Text Key: 338187028
• Report Number: 2025587-2024-01795
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 03/20/2024

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: Not provided
• Initial Date FDA Received: 03/20/2024
• 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): Life Threatening; Required Intervention
• Patient Age: 84 YR
• Patient Sex: Male