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

Model Number	AJ-501
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/15/2023
Type of Reportable Event	Death
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), 2023, a 21mm sjm masters series mechanical heart valve was selected for procedure.It was noted during procedure that a leaflet of the valve fractured into several pieces when pivoting the valve.The patient status is unknown.
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) 2023, a 21mm sjm masters series mechanical heart valve was selected for procedure.It was noted during procedure that a leaflet of the valve fractured into several pieces when pivoting the valve.The patient had remained hemodynamically stable throughout the implant procedure.On (b)(6) 2023, the patient died due to an unknown cause.
Additional Manufacturer Narrative
Additional information: g3, g6, h2, h6, h10 an event of valve leaflet fracture was reported.The possible causes of the reported event include an external force applied to the valve leaflets that may cause structural damage, the use of a hard or rigid instruments to test leaflet mobility and oversizing of the valve.A returned device inspection, to rule out any device-related causes, could not be performed as the device was not returned for analysis.Information from the field indicated that during testing the valve fractured into pieces.Abbott requested additional information on the reported incident but was not provided any.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all defined manufacturing specifications.Based on the information received, the cause of the reported event of valve fracture could not be conclusively determined but may have been caused by some external force being applied to the valve which overstressed the carbon material.The cause of the reported death could not be conclusively determined but is unlikely related to the fractured leaflet and additional time required to replace the valve.There is no indication of a product quality issue with regards to manufacture, design, or labelingna.
Event or Problem Description
It was reported that on (b)(6) 2023, a 21mm sjm masters series mechanical heart valve was selected for procedure.It was noted during procedure that a leaflet of the valve fractured into several pieces when pivoting the valve.The patient had remained hemodynamically stable throughout the implant procedure.On (b)(6) 2023, the patient died due to an unknown cause.

• 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 MN 00725
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16594837
• Report Number: 2135147-2023-01301
• Device Sequence Number: 2834911
• Product Code: LWQ
• UDI-Device Identifier: 05414734021104
• UDI-Public: 05414734021104
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Followup
• Report Date (Section B): 06/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/28/2023
• Device Model Number: AJ-501
• Device Catalogue Number: 21AJ-501
• Device Lot Number: 86902488
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/27/2023
• Supplement Date Received by Manufacturer: 05/05/2023; 06/01/2023
• Initial Report FDA Received Date: 03/22/2023
• Supplement Report FDA Received Date: 05/30/2023; 06/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2018
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown