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); Insufficient Information (3190)

Patient Problems Stroke/CVA (1770); Non specific EKG/ECG Changes (1817); Hemothorax (1896); Sepsis (2067); Valvular Insufficiency/ Regurgitation (4449)

Event Date 02/05/2024

Event Type  Death  

Manufacturer Narrative

Citation: ammar et al.Intentional oversizing of valve in transcatheter aortic valve replacement: is bigger better? a large, single-center experience.Structural heart.2024.Doi.Org/10.1016/j.Shj.2023.100278.Published online: february 05, 2024.Earliest date of publication used for date of event and date of death.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 the clinical impact of oversizing of self-expanding valves in transcatheter aortic valve replacement.The study population included 556 patients with a mean age of 82.6 years who were predominantly female.  multiple manufacturer¿s devices were implanted in the study population; an undisclosed number of patients were implanted with a medtronic corevalve, evolut r or evolut pro bioprosthetic valve.  ten in-hospital deaths occurred due to: paravalvular leak (n=3), permanent pacemaker implantation (n=2), stroke (n=1), sepsis (n=1), hemothorax (n=1), severe left ventricular systolic function reduction (n=1), and multifactorial (n = 1).  of note, there was no statement establishing a causal or contributory relationship between medtronic product and the deaths.  among all patients adverse events included: arrhythmia requiring permanent pacemaker implant, moderate to severe paravalvular leak, stroke, cardiac perforation, tamponade, major bleeding complication, valve migration, cardiac arrest, dissection, annular rupture, atrial fibrillation, myocardial infarction, hematoma, pseudoaneurysm and unplanned intervention.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: 18946839
• MDR Text Key: 338183778
• Report Number: 2025587-2024-01797
• 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: 03/20/2024

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: Not provided
• Initial Date FDA Received: 03/20/2024
• 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): Death
• Patient Age: 83 YR
• Patient Sex: Female