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

Catalog 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	07/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on 24 jul.2024, a 27mm masters valve was selected for implant.During prep, the valve leaflets were moving normally.During the heart replacement procedure, the physician discovered that the valves leaflets opened and closed abnormally.The valve was removed and replaced with another 27mm masters valve to resolve the event without removing the patient from bypass.The explanted valve was tested and leaflets were moving normally.There was no clinically significant delay during the procedure.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
It was reported that the valves leaflets opened and closed abnormally during procedure so the valve was removed and replaced.Field indicated that the valve leaflets were moving normally during preparation.Also reported that the explanted valve was tested and leaflets were moving normally.No anomalies were found with the valve leaflets upon return to abbott, and functional testing including hydrodynamic testing showed indicated the valve functioned normally.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications including functioning of the valve.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.
Event or Problem Description
It was reported that on (b)(6) 2024, a 27mm masters valve was selected for implant.During prep, the valve leaflets were moving normally.During the heart replacement procedure, the physician discovered that the valves leaflets opened and closed abnormally.The valve was removed and replaced with another 27mm masters valve to resolve the event without removing the patient from bypass.The explanted valve was tested and leaflets were moving normally.There was no clinically significant delay during the procedure.

• 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: 19992176
• Report Number: 2135147-2024-03977
• Device Sequence Number: 20968349
• Product Code: LWQ
• UDI-Device Identifier: 05415067045034
• UDI-Public: (01)05415067045034(17)241019(10)7236803
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 10/24/2024

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 Expiration Date: 10/19/2024
• Device Catalogue Number: 27MJ-501
• Device Lot Number: 7236803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/24/2024
• Supplement Date Received by Manufacturer: 10/21/2024
• Initial Report FDA Received Date: 08/15/2024
• Supplement Report FDA Received Date: 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2019
• 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