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

Catalog Number	27MJ-501
Medical Device Problem Code	Incomplete Coaptation (2507)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2023
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 11 july 2023, a 27mm sjm masters series mechanical heart valve was selected for implant in the patient.After implantation of the valve, the physician closed the incision of heart.The physician found that one leaflets couldn't move during transesophageal echocardiogram (tee).The physician stopped the blood circulation and opened the heart incision again.He used a tester of silicon to test the leaflet function and found that one leaflet couldn't move normally.So, the physician had to explant the valve, and replaced a new 27mm sjm masters series mechanical heart valve.Once explanted, the original valve leaflet was not moving normally.The procedure time was extended about 60 minutes.The procedure was finished successfully.The patient remained stable throughout the procedure.The patient status was stable in the post operative recovery period.The patient was taking warfarin, and the latest international normalized ratio (inr) was 2.0-2.5.
Additional Manufacturer Narrative
An event of one leaflet would not move after implantation was reported.It was also reported that the valve was explanted and a leaflet was not moving normally.The investigation at abbott found no device anomalies.Morphological and hydrodynamic examination indicated the valve met abbott specifications.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Hydrodynamic testing upon return to abbott and at the time of manufacturing indicated the valve functioned normally.This test ensures proper leaflet coaptation and hemodynamic performance.The cause of the reported event could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Please note that per the instructions for use, "use st.Jude medical¿ leaflet testers, model lt100*, to test leaflet mobility.".

• 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: 17435937
• Report Number: 2135147-2023-03349
• Device Sequence Number: 18387051
• Product Code: LWQ
• UDI-Device Identifier: 05414734006460
• UDI-Public: 05414734006460
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2023

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 Catalogue Number: 27MJ-501
• Device Lot Number: C00004577
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/11/2023
• Supplement Date Received by Manufacturer: 08/22/2023
• Initial Report FDA Received Date: 08/01/2023
• Supplement Report FDA Received Date: 09/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2022
• 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: Required Intervention
• Patient Sex: Unknown