MAUDE Adverse Event Report: ABBOTT MEDICAL Masters Series Valve Expanded Cuff; Heart-Valve, Mechanical

Model Number	27MECJ-502
Medical Device Problem Codes	Fracture (1260); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2026, a 27mm sjm masters series valve expanded cuff was chosen for a procedure.While rotating the valve a moderate resistance was felt.During the procedure, after the valve implant when they rotated the valve both leaflets popped out.They confirmed both leaflets were recovered.They explanted it and replaced with a new 27mm sjm masters series valve expanded cuff.There was some delay occurred from excising first valve and placing second valve.The patient was reported in post operative recovery course.
Additional Manufacturer Narrative
An event involving leaflet sticking and difficulty rotating the valve during implantation was reported.The device was returned to abbott for evaluation.Investigation confirmed that the valve was received with both leaflets dislodged from the orifice, and chip damage was observed on the butterfly wall.Functional assessment demonstrated that the valve rotated freely.A review of the device history record (dhr) found no manufacturing nonconformances, rework activities, or process deviations associated with the device.In addition, no inconsistencies were identified between the manufacturing process controls and the applicable fmea requirements.The dhr for the serial confirmed that the device was manufactured in accordance with abbott manufacturing specifications.Based on the investigation, there was no evidence to indicate that the reported event was related to the device design, manufacturing process, or labeling.Therefore, no abbott-related product quality issue was identified.The exact root cause of the reported leaflet dislodgement and rotation difficulty could not be conclusively determined.No product quality deficiency associated with the device's design, manufacturing, or labeling was identified.

• Brand Name: Masters Series Valve Expanded Cuff
• 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 ; PR 00725
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; +1(651)756-5400
• MDR Report Key: 25855383
• Report Number: 2135147-2026-04892
• Device Sequence Number: 5266674
• Product Code: LWQ
• UDI-Device Identifier: 05415067045232
• UDI-Public: (01)05415067045232(17)300528
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 27MECJ-502
• Device Catalogue Number: 27MECJ-502
• Device Lot Number: C00030565
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/07/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2026
• Supplement Date Received by Manufacturer: 09/24/2026
• Initial Report FDA Received Date: 07/17/2026
• Supplement Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2025
• 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
• Patient Sex: Unknown