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

Model Number CRS

Device Problems Gradient Increase (1270); Perivalvular Leak (1457)

Patient Problems Dyspnea (1816); Valvular Insufficiency/ Regurgitation (4449)

Event Date 01/01/2024

Event Type  Injury  

Event Description

Literature was reviewed regarding a 73-year-old female patient who ten years prior underwent implant of a medtronic 31-mm corevalve bioprosthetic valve for treatment of severe aortic stenosis.  following this procedure residual severe paravalvular leak (pvl) persisted resulting in progressive dyspnea.  one year later, the patient underwent a valve-in-valve (viv) implant of a second medtronic 31-mm corevalve bioprosthetic valve in a higher position which reduced the pvl from severe to moderate.  more recently the patient presented with new-onset dyspnea.  a transthoracic echocardiogram (tte) and computed tomography angiography (cta) confirmed high transvalvular gradients and severe pvl at the location of an annular calcification nodule.  subsequently the patient underwent implant of a non-medtronic transcatheter bioprosthetic valve reducing the pvl from severe to less-than-moderate and reduced the transvalvular gradients.  a small annular pseudoaneurysm was identified; however, after two hours of monitoring the patient remained asymptomatic and hemodynamically stable.  at seven days post-procedure the pseudoaneurysm was completely sealed.  the patient was discharged at 10 days post-procedure.  no further information was provided pertaining to medtronic products.

Manufacturer Narrative

Citation: frittitta et al.Late third transcatheter aortic valve replacement for treatment of persistent paravalvular regurgitation.J am coll cardiol case rep.2024 apr, 29 (7) 102259.Doi.Org/10.1016/j.Jaccas.2024.102259.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.

• Brand Name: COREVALVE 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: 18975699
• MDR Text Key: 338548398
• Report Number: 2025587-2024-01889
• 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: 03/25/2024

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: CRS
• Device Catalogue Number: CRS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/25/2024
• 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
• Patient Age: 73 YR
• Patient Sex: Female