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

Catalog Number	600110046
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on 05 december 2023, a 29mm mitral masters series mechanical heart valve was chosen for implant.A resistance was met when rotating the valve with the valve rotator.The valve was placed on the mitral valve.During suturing of the valve, it was observed that the valve leaflet dislodged as one piece.The valve was opened and removed.The intact leaflet was recovered from the patient.A 29mm non-abbott replacement valve was used to complete the procedure.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.
Additional Manufacturer Narrative
An event of a leaflet dislodgement was reported.The device was returned to abbott for investigation, both leaflets were received dislodged.The butterfly wall contained a small chip.No other anomalies were found.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and that the product met all defined manufacturing specifications.Information from the field indicated that the valve was placed on the mitral valve while suturing the valve, it was observed that the valve leaflet dislodged as one piece.While the root cause of the leaflet fracture could not be conclusively determined, the damage is consistent with some external force being applied to the leaflet when rotating the valve.There was no evidence of the material defect in the carbon coating that may have caused or contributed to the reported event.

• 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): 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: 18416462
• Report Number: 2135147-2023-05738
• Device Sequence Number: 8174373
• Product Code: LWQ
• UDI-Device Identifier: 05414734006552
• UDI-Public: 05414734006552
• 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: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2024

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 Catalogue Number: 600110046
• Device Lot Number: 8273498
• 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: 12/05/2023
• Supplement Date Received by Manufacturer: 01/14/2024
• Initial Report FDA Received Date: 12/29/2023
• Supplement Report FDA Received Date: 01/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/22/2021
• 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: 49 YR
• Patient Sex: Male
• Patient Weight: 67 KG