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

Model Number EVOLUTR-26

Device Problems Perivalvular Leak (1457); Patient Device Interaction Problem (4001)

Patient Problems Non specific EKG/ECG Changes (1817); Unspecified Infection (1930); Thrombosis/Thrombus (4440); Heart Failure/Congestive Heart Failure (4446); Valvular Insufficiency/ Regurgitation (4449)

Event Date 02/21/2024

Event Type  Injury  

Manufacturer Narrative

Citation: evola et al.Intravascular lithotripsy (ivl) enabled the percutaneous closure of a severely calcified paravalvular leak r egurgitation following implantation of a self-expandable transcatheter aortic valve: a case report.Front cardiovasc med.2024 feb 21:11:1359711.Doi: 10.3389/fcvm.2024.1359711.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 an 85-year-old female patient who underwent transcatheter aortic valve implantation (tavi) of a medtronic 26-mm evolut r bioprosthetic valve to treat severe symptomatic aortic stenosis.  a few days post-tavi, a cardiac resynchronization therapy device (crt) implantation was implanted, which was complicated by infection and left upper limb thrombosis which then required explantation of the crt.  approximately eighteen months post-tavi the patient presented with signs of congestive heart failure.  transesophageal echocardiography (tee) showed moderate to severe paravalvular leak (pvl) with noted calcifications. the patient was deemed a surgical risk therefore a catheter-based pvl closure procedure was planned. during the intervention, intravascular lithotripsy was applied to the highly calcified area at the site of the pvl, which then allowed for successful deployment of a non-medtronic occluder at the leak site.  the final echocardiographic and angiographic control confirmed the effective pvl closure. no further information was provided pertaining to medtronic products.

• 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: 18984019
• MDR Text Key: 338658131
• Report Number: 2025587-2024-01918
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 03/26/2024

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-26
• Device Catalogue Number: EVOLUTR-26
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/26/2024
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 85 YR
• Patient Sex: Female