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

Model Number	27AJ-501
Medical Device Problem Codes	Incomplete Coaptation (2507); Device Stenosis (4066)
Health Effect - Clinical Code	Aortic Valve Stenosis (1717)
Date of Event	05/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2025, a 27mm masters mechanical aortic valve was implanted.Procedure was uneventul.Prior to discharge, a gradient of 80mmhg was observed.Transesophageal echocardiography (tee) showed one leaflet not opening.On an unknown date, the valve was explanted and a 25mm master valve was used as replacement.Upon further analysis outside the patient, the leaflet was still difficult to open when manually manipulated.
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of explant as one of the leaflets was not opening was reported.Information from field indicated that procedure was uneventful.Also reported that prior to discharge a gradient of 80 mmhg was observed.A returned device assessment could not be performed as the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.It is possible that the valve was over-sized as a smaller sized valve was used as replacement.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all defined manufacturing specifications.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Codes removed: type of investigation: 4118 types of investigation not yet determined.Investigation findings: 3233 results pending completion of investigation.Investigation conclusions: 11 conclusions not yet available.
Event or Problem Description
It was reported that on (b)(6) 2025, a 27 mm masters mechanical aortic valve was implanted.Procedure was uneventul.Prior to discharge, a gradient of 80 mmhg was observed.Transesophageal echocardiography (tee) showed one leaflet not opening.On an unknown date, the valve was explanted and a 25 mm master valve was used as replacement.Upon further analysis outside the patient, the leaflet was still difficult to open when manually manipulated.
Event or Problem Description
It was reported that on (b)(6) 2025, a 27mm masters mechanical aortic valve was implanted.Procedure was uneventul.Prior to discharge, a gradient of 80mmhg was observed.Transesophageal echocardiography (tee) showed one leaflet not opening.On an unknown date, the valve was explanted and a 25mm master valve was used as replacement.Upon further analysis outside the patient, the leaflet was still difficult to open when manually manipulated.
Additional Manufacturer Narrative
Explant due to one leaflet not opening and device stenosis was reported.The device was returned to abbott for investigation.The orifice, pivot guards and recessed pivot areas did not have any visible evidence of surface damage or anomalies.Both leaflets were intact, properly inserted within the orifice, and did not contain any surface damage.Both leaflets were able to fully open and close.Hydrodynamic testing upon return to abbott, which ensures proper leaflet coaptation, indicated the valve functioned normally.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, including functional testing at the time of manufacturing, and the product met all specifications.Based on the information received, the cause of the reported high-pressure gradient is likely related to one leaflet not opening.However, the cause of the reported one leaflet not opening could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• Brand Name: MASTERS SERIES MECHANICAL HEART VALVE
• Common Device Name: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG# 2648612; lot 20 b st caguas; caguas 00725 ; * 00725
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 22214866
• Report Number: 2135147-2025-03242
• Device Sequence Number: 8659848
• Product Code: LWQ
• UDI-Device Identifier: 05415067043078
• UDI-Public: (01)05415067043078(17)290902
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/19/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 27AJ-501
• Device Catalogue Number: 27AJ-501
• Device Lot Number: C00023658
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2025
• Supplement Date Received by Manufacturer: 07/10/2025; 12/01/2025
• Initial Report FDA Received Date: 06/16/2025
• Supplement Report FDA Received Date: 07/18/2025; 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Male