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

Model Number AJ-501

Device Problem Fracture (1260)

Patient Problem Insufficient Information (4580)

Event Date 02/15/2023

Event Type  Death  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event 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.

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event 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.

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 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
• Type of Device: 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
• MDR Text Key: 312303881
• Report Number: 2135147-2023-01301
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734021104
• UDI-Public: 05414734021104
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 06/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death