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

Catalog Number	31MJ-501
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2024
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 (b)(6) 2024, a 31mm sjm masters series valve expanded cuff valve was chosen for a procedure.During procedure, the surgeon was suturing the valve in place and possibly attempted to reposition valve and somehow the leaflet got broke.The valve was explanted and a new 31mm sjm masters series valve expanded cuff was chosen and completed the procedure.
Additional Manufacturer Narrative
An event of leaflet fracture was confirmed.The investigation found one leaflet to be fractured into two pieces.The valve rotated freely.The valve was visually and microscopically examined.The sewing cuff was noted to be torn and contained blood/body fluids, which is consistent with damage during use.The recessed pivot areas, pivot guards, intact leaflet did not contain any visible evidence of surface damage or anomalies.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.While the root cause of the leaflet dislodgement could not be conclusively determined, there was no evidence of material defect in the carbon coating that may have caused or contributed to the dislodged leaflet.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 31mm sjm masters series valve expanded cuff valve was chosen for a procedure.During procedure, the surgeon was suturing the valve in place and possibly attempted to reposition valve and somehow one of the pieces came off.The valve was explanted and a new 31mm sjm masters series valve expanded cuff was chosen and completed 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: 20557251
• Report Number: 2135147-2024-05361
• Device Sequence Number: 16922727
• Product Code: LWQ
• UDI-Device Identifier: 05415067045072
• UDI-Public: (01)05415067045072(17)241103(10)7259160
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2025

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 Expiration Date: 11/03/2024
• Device Catalogue Number: 31MJ-501
• Device Lot Number: 7259160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/04/2024
• Supplement Date Received by Manufacturer: 01/17/2025
• Initial Report FDA Received Date: 10/29/2024
• Supplement Report FDA Received Date: 01/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2019
• 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