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

Model Number	27MJ-501
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2025, a 27mm masters valve was selected for implant.There were no issues noted during prep.Once the valve was implanted, it was noted that there was poor opening and closing of the valve leaflets.The device was removed and replaced with a non-abbott valve to resolve the event.The patient was never taken off of bypass.The physician doesn't believe the patient or user experienced adverse health consequences due to the performance of the product.The patient remained hemodynamically stable throughout the procedure.The patient is stable.
Event or Problem Description
It was reported that on (b)(6) 2025, a 27mm masters valve was selected for implant.There were no issues noted during prep.Once the valve was implanted, it was noted that there was poor opening and closing of the valve leaflets.The device was removed and replaced with a non-abbott valve to resolve the event.The patient was never taken off of bypass.The physician doesn't believe the patient or user experienced adverse health consequences due to the performance of the product.The patient remained hemodynamically stable throughout the procedure.The patient is stable.
Additional Manufacturer Narrative
An event of valve leaflets were coopting well after implant was reported.The valve was returned with a dislodged leaflet and an intact leaflet.The cuff weas able to rotate freely.The valve was able to be rotated freely.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.The cause of the reported event 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: 21858467
• Report Number: 2135147-2025-02007
• Device Sequence Number: 11933322
• Product Code: LWQ
• UDI-Device Identifier: 05415067045034
• UDI-Public: (01)05415067045034(17)280318
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 27MJ-501
• Device Catalogue Number: 27MJ-501
• Device Lot Number: C00010045
• 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: 03/23/2025
• Supplement Date Received by Manufacturer: 04/24/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 05/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/20/2023
• 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 Age: 24 YR
• Patient Sex: Female
• Patient Weight: 58 KG