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

Model Number MDT-TRANS VALVE

Device Problems Gradient Increase (1270); Perivalvular Leak (1457); Inadequacy of Device Shape and/or Size (1583); Patient Device Interaction Problem (4001)

Patient Problems Stroke/CVA (1770); Non specific EKG/ECG Changes (1817); Obstruction/Occlusion (2422); Heart Failure/Congestive Heart Failure (4446); Valvular Insufficiency/ Regurgitation (4449)

Event Date 03/11/2024

Event Type  Injury  

Manufacturer Narrative

Citation: scotti a, sturla m, costa g, et al.Evolut pro and sapien ultra performance in small aortic annuli: the opera-tavi registry.Jacc cardiovasc interv.2024;17(5):681-692.Doi:10.1016/j.Jcin.2024.01.006 earliest date of publication used for date of event.Medtronic products referenced: evolut pro (product code npt, pma# p130021) and evolut pro+ (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.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.

Event Description

Literature was reviewed regarding a comparison of the medtronic evolut pro and pro+ (n = 251) and the non-medtronic sapien 3 ultra (n = 251) transcatheter aortic valve replacement (tavr) platforms in patients with small aortic annuli.In the evolut r/pro+ group, the authors observed a kaplan-meier estimated rate of 26 all-cause deaths within one year of tavr.No evidence was presented to suggest that a medtronic product or its function contributed to any of the deaths.Other adverse events that occurred in the evolut r/pro+ group were described as follows: need for valve recapturing/repositioning during procedure, two transcatheter valves implanted during procedure, coronary obstruction during procedure, stroke (disabling or non-disabling), permanent pacemaker implantation, hospitalization for heart failure, prosthesis-patient mismatch, residual mean gradient = 20 mm hg, and trace to moderate paravalvular leak (pvl).The authors stated that there were no cases of severe pvl in the overall study cohort.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: 19076324
• MDR Text Key: 339774704
• Report Number: 2025587-2024-02187
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 04/09/2024

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: MDT-TRANS VALVE
• Device Catalogue Number: MDT-TRANS VALVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2024
• Initial Date FDA Received: 04/09/2024
• 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; Disability; Life Threatening; Hospitalization
• Patient Age: 82 YR
• Patient Sex: Female