MAUDE Adverse Event Report: ABBOTT MEDICAL STANDARD MECHANICAL HEART VALVE; HEART-VALVE, MECHANICAL

Catalog Number 21AEC-102

Device Problem Perivalvular Leak (1457)

Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 10/13/2022

Event Type  Injury  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that on (b)(6) 2022, a 21mm mechanical aortic valve and a 25mm sjm mechanical mitral valve were successfully implanted in a patient.On (b)(6) 2022, it was reported that the patient developed a tumor in the sub-valvular aorta.In addition, mild leakage was noted from the sewing cuff of the implanted aortic valve.Although the degree of regurgitation was not considered clinically significant, the decision was made to remove the tumor and the aortic device.The valve is planned to be replaced with a sjm regent valve.No issue was reported with the implanted mitral sjm valve.No patient consequences were reported.

Manufacturer Narrative

An event of mild leakage from the sewing cuff of the valve was reported.Information from the field indicates that the patient was diagnosed with a tumor in the subvalvular aorta which lead to valve explant.Also, the field indicates that the physician has not alleged any malfunction for abbott valves, and the valve was explanted because of a patient medical condition.A returned device assessment, to see if there were any anomalies with the valve could not be performed as the device was not returned for analysis.

• Brand Name: STANDARD MECHANICAL HEART VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC. REG#2648612; 20 b st caguas west park; caguas 00725 ; * 00725
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 15729031
• MDR Text Key: 303049983
• Report Number: 2135147-2022-01920
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 21AEC-102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2008
• 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): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female