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); Thickening of Material (4056)

Patient Problems Atrial Fibrillation (1729); Non specific EKG/ECG Changes (1817); Endocarditis (1834); Pneumonia (2011); Urinary Tract Infection (2120); Rupture (2208); Cardiac Tamponade (2226); Heart Block (4444); Heart Failure/Congestive Heart Failure (4446); Valvular Insufficiency/ Regurgitation (4449)

Event Date 10/30/2023

Event Type  Injury  

Event Description

Literature was reviewed regarding vascular access site complications after transfemoral transcatheter aortic valve implantation (tavi).Medtronic corevalve and evolut r/pro (n = 95) and non-medtronic sapien xt/3 (n = 256) tavi systems were used in the study.Of note, the authors indicated that the corevalve and evolut r/pro systems were inserted through a non-medtronic gore dryseal introducer sheath.Overall, five deaths were observed within thirty days of tavi.No evidence was presented to suggest that a medtronic product or its function contributed to any of the deaths.Vascular access site complications consisted of common femoral artery dissection, common femoral artery stenosis, femoral artery pseudoaneurysm, external iliac artery injury, external iliac artery dissection, bleeding, transfusions, and wound dehiscence.Treatment for the access site complications comprised: endovascular repair, artificial graft replacement, femoro-femoral artery bypass, and catheter balloon dilation.Non-access site complications included: cerebrovascular disease, coronary event, pericardial tamponade, heart failure, arrhythmias/conduction disturbances (atrial fibrillation, complete atrioventricular block, right or left bundle branch block, sick sinus syndrome), need for permanent pacemaker implantation, paravalvular leak (moderate or greater), leaflet thickening, endocarditis, left ventricular rupture, pneumonia, and urinary tract infection.No additional adverse events were noted.

Manufacturer Narrative

Citation: sumii y, morisaki a, okai t, et al.Vascular access site complications after transfemoral transcatheter aortic valve impla ntation: a comparison of open and percutaneous puncture approaches.J thorac dis.2023;15(11):5901-5912.Doi:10.21037/jtd-23-999 earliest date of publication used for date of event.Medtronic products referenced: corevalve system (product code npt, pma# p130021), evolut r system (product code npt, pma# p130021), evolut pro system (product code npt, pma# p130021).Earliest approved product used for product code and pma#.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.Medtronic will submit a supplemental report if additional relevant information becomes known.

• 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: 18996431
• MDR Text Key: 338875913
• Report Number: 2025587-2024-01962
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• 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: 02/29/2024
• 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