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

Model Number EVOLUTR-29

Device Problems Gradient Increase (1270); Perivalvular Leak (1457); Device Dislodged or Dislocated (2923); Patient Device Interaction Problem (4001)

Patient Problems Dyspnea (1816); Non specific EKG/ECG Changes (1817); Respiratory Failure (2484); Valvular Insufficiency/ Regurgitation (4449)

Event Date 02/16/2024

Event Type  Injury  

Manufacturer Narrative

Citation: molina-lopez vh, partida-rodriguez e, rivera-babilonia j, rodriguez-ospina l.Successful rescue transaortic valve replacement using edwards sapien 3 following failed evolut r implantation in a degenerated surgical bioprosthesis: a case report.Cureus.20 24;16(2):e54318.Published 2024 feb 16.Doi:10.7759/cureus.54318 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 a patient who had a 29 mm medtronic evolut r transcatheter valve implanted valve-in-valve in a degenerated 25 mm non-medtronic surgical valve (magna ease).During the procedure, the authors stated that multiple attempts were made to reposition the valve, eventually achieving the desired implant depth but ¿micro-dislodgement¿ into the left ventricular outflow tract (lvot) occurred after the valve was fully deployed.Angiography showed trace paravalvular leak (pvl).A transvalvular mean gradient of 18 mmhg was noted.Subsequently, the authors cracked/fractured the surgical valve ring using a 26 mm non-medtronic (true dilatation) non-compliant balloon, resulting in good expansion.However, the evolut r valve further migrated into the lvot with progressive dyspnea and hypoxemic respiratory failure, necessitating endotracheal intubation and mechanical ventilation.The micro-dislodgement and further migration after valve fracture also led to severe pvl with a marked widening of the pulse pressure on invasive hemodynamics and an aortic regurgitation index of 18%.Transesophageal echocardiography revealed ¿massive¿ circumferential supra-skirt pvl.Consequently, a 26 mm non-medtronic transcatheter valve (sapien 3) was successfully implanted valve-in-valve-in-valve (sapien 3-in-evolut r-in-magna ease).Post-procedural transthoracic echocardiography showed normal functioning of the valve-in-valve-in-valve sapien 3 with trace pvl and no patient-prosthetic mismatch.Post-procedural left bundle branch block was logged but resolved before hospital discharge.The authors wrote that the patient was followed closely for the next three years and remained without complications from the intervention and died three years later from non-cardiovascular causes.

• 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: 19137624
• MDR Text Key: 340561664
• Report Number: 2025587-2024-02350
• 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: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EVOLUTR-29
• Device Catalogue Number: EVOLUTR-29
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2024
• 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: 86 YR
• Patient Sex: Male