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

Model Number	27MJ-501
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Air Embolism (1697); Stroke/CVA (1770)
Date of Event	01/03/2023
Type of Reportable Event	Serious Injury
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 27mm sjm masters series mechanical heart valve was selected for procedure.It was noted during procedure that a leaflet of the valve fractured as one whole piece when rotating the valve with the valve rotator and holder handle.It was noted that there a had been a bit of resistance when rotating the 27mm sjm masters series mechanical heart valve in the closed position.No other instruments came in contact with the valve at the time of the leaflet fracture.The implanting physician did not try to reinsert the fractured leaflet and nothing other than the valve holder handle was used to rotate the valve.The holder handle was fully inserted into the orifice at a 90 degree angle.The decision was made to remove the fractured leaflet piece and the 27mm sjm masters series mechanical heart valve and replaced it with a 27mm epic valve to complete the procedure.The patient was not taken off bypass and put back on and remained hemodynamically stable throughout the procedure.However, at an unknown point the patient suffered a stroke.The patient was stable and recovering at the time of report, with full recovery of neurological function.
Additional Manufacturer Narrative
An event of the valve leaflet dislodging after the valve was rotated was reported.The investigation found that one leaflet was dislodged from the orifice and that the orifice was chipped.Information from the field indicated that there was "a bit" of resistance while rotating the valve, that no instruments were in contact with the valve when the leaflet dislodged and that only the valve rotator was used when rotating the valve.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The cause of the reported event could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.H10.
Event or Problem Description
It was reported that on 03 january 2023, a 27mm sjm masters series mechanical heart valve was selected for procedure.It was noted during procedure that a leaflet of the valve fractured as one whole piece when rotating the valve with the valve rotator and holder handle.It was noted that there a had been a bit of resistance when rotating the 27mm sjm masters series mechanical heart valve in the closed position.No other instruments came in contact with the valve at the time of the leaflet fracture.The implanting physician did not try to reinsert the fractured leaflet and nothing other than the valve holder handle was used to rotate the valve.The holder handle was fully inserted into the orifice at a 90 degree angle.The decision was made to remove the fractured leaflet piece and the 27mm sjm masters series mechanical heart valve and replaced it with a 27mm epic valve to complete the procedure.The patient was not taken off bypass and put back on and remained hemodynamically stable throughout the procedure.However, at an unknown point the patient suffered a stroke.The patient was stable and recovering at the time of report, with full recovery of neurological function.Subsequent to the previously filed report, additional information was received that the patient suffered a stroke on 04 january 2023, the first post-operative day.There was no intervention required or performed for the patient's stroke.The cause of the stroke is believed to have been from an air embolism, however no definite air embolism was confirmed.The patient had a complete recovery with no residual stroke symptoms.No prolonged hospitalization was reported.No aspiration was required.
Additional Manufacturer Narrative
An event of the valve leaflet dislodging after the valve was rotated was reported.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.Information from the field indicated that there was "a bit" of resistance while rotating the valve, that no instruments were in contact with the valve when the leaflet dislodged and that only the valve rotator was used when rotating the valve.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The cause of the reported event could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.H6 health effect - impact code: code 4648 removed.

• 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: 16474813
• Report Number: 2135147-2023-00982
• Device Sequence Number: 7579369
• Product Code: LWQ
• UDI-Device Identifier: 05414734006460
• UDI-Public: 05414734006460
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/21/2023

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 Model Number: 27MJ-501
• Device Catalogue Number: 27MJ-501
• Device Lot Number: C00002033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/07/2023
• Supplement Date Received by Manufacturer: 04/10/2023; 04/21/2023
• Initial Report FDA Received Date: 03/02/2023
• Supplement Report FDA Received Date: 04/18/2023; 04/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2022
• 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: Hospitalization; Other
• Patient Sex: Unknown