SIMULUS SEMI-RIGID ANNULOPASTY RING

Description of Event or Problem

Medtronic received information that 3 years and 6 months post implant of this 36mm SimuForm heart ring, the patient was being evaluated. The reason for the evaluation was reported as moderate to severe mitral regurgitation (MR). A transesophageal echocardiogram (TEE) is scheduled. 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.