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

Model Number MDT-TRANS VALVE

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

Patient Problems Non specific EKG/ECG Changes (1817); Hemorrhage/Bleeding (1888); Myocardial Infarction (1969); Cardiac Tamponade (2226); Cardiovascular Insufficiency (4445); Valvular Insufficiency/ Regurgitation (4449); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 03/04/2024

Event Type  Injury  

Manufacturer Narrative

Citation: mas-peiro et al.Optimal oversizing in transcatheter aortic valve replacement with the self-expanding evolut valve system.J invasive cardiol.2024 mar 4.Doi: 10.25270/jic/24.00011.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.Select patient information cannot be included in regulatory report due to regional privacy regulations.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 optimal oversizing in transcatheter aortic valve replacement (tavr) with the medtronic evolut valve.The study population included 740 patients with a mean age of 83.9 years who were predominantly female.  all patients were implanted with a medtronic evolut r, evolut pro or evolut pro+ bioprosthetic valve.  there were three (0.4%) procedural and 20 (2.7%) in-hospital deaths that occurred in the study population.  no further details were provided on these deaths.  of note, there was no statement establishing a causal or contributory relationship between medtronic product and the deaths.  adverse events included: cardiac tamponade, coronary obstruction, valve migration, acute kidney injury, major vascular complication, major bleeding complication, arrhythmia requiring permanent pacemaker implant, moderate to severe paravalvular leak, moderate to severe aortic regurgitation, myocardial infarction, and conversion to open surgery.  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: 18955485
• MDR Text Key: 338302887
• Report Number: 2025587-2024-01833
• 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,Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 03/13/2024
• 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; Hospitalization; Required Intervention