Hancock II Aortic Bioprosthetic Heart Valve

Description of Event or Problem

It was reported that 10 years and 9 months post implant of this 27mm aortic bioprosthetic valve, the patient is being evaluated for a transcatheter valve-in-valve replacement. The reason for evaluation was reported as stenosis. It was reported that an intervention is required. Subsequently 3 days later on (b)(6) 2026 the patient successfully had a 26mm aortic transcatheter valve-in-valve replacement. No additional adverse patient effects were reported.

Additional Manufacturer Narrative

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.