MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION UNKNOWN STRUCTURAL HEART PRODUCT; HEART-VALVE, MECHANICAL

Model Number SH UKNOWN

Device Problems Gradient Increase (1270); Incomplete Coaptation (2507); Insufficient Information (3190)

Patient Problems Dyspnea (1816); Insufficient Information (4580)

Event Date 11/13/2021

Event Type  Death  

Event Description

Medtronic received information that 8 years and 7 months post implant of this aortic mechanical valve (manufacturer unknown), the patient presented to the emergency department with exertional shortness of breath and chest pressure.He was admitted to the hospital for further management and diuresis.One day later, transesophageal echocardiogram (tee) revealed elevated gradients with an aorticvalve area of 0.6cm^2.One of the mechanical valve leaflets was mobile, but the other leaflet was "stuck in position".Prior to being able to administer medication, the patient had a pulseless electrical activity (pea) arrest.Advanced cardiovascular life support (acls) was provided, but the patient did not regain a perfusing rhythm and died.

Manufacturer Narrative

This regulatory report is being submitted as part of a retrospective review and remediation per (b)(4) related to capa pr 564122.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: UNKNOWN STRUCTURAL HEART PRODUCT
• Type of Device: HEART-VALVE, MECHANICAL
• 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: 18953627
• MDR Text Key: 338276005
• Report Number: 2025587-2024-01830
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P990046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SH UKNOWN
• Device Catalogue Number: SH UKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Weight: 79 KG