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

Model Number	29MJ-501
Medical Device Problem Codes	Incomplete Coaptation (2507); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	04/24/2023
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 29mm mitral masters series std valve was selected for implant in the patient.At the time of device preparation, the leaflets were moving normally.After implantation of the valve, the physician closed the incision of heart.The physician found that one leaflet of valve couldn't move during the transesophageal echocardiogram (tee).Then the physician stopped the blood circulation and opened the heart incision again.He found that there was some thrombus in the pivot of valve which affected the function of one leaflet.So the physician explanted the valve, then replaced with a non-abbott device.The procedure time was extended about 45 minutes.The patient was given heparin with activated clotting time (act) of >500 seconds.The procedure was finished successfully without patient consequence.The patient remained stable throughout the procedure and is currently safe and stable.
Additional Manufacturer Narrative
Explant due to leaflets not moving normally and thrombus in the pivot of valve affecting functioning of valve was reported.The investigation found dark red biological material consistent with blood was present by one of the pivot guards.No anomalies were found with the valve leaflets, functional testing at the time of manufacturing and upon return to abbott indicated the valve functioned normally.This test ensures proper leaflet coaptation and hemodynamic performance.The free state of the leaflets, without physiological pressure applied, is not indicative of actual leaflet coaptation or valve function.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.Two videos from field appeared to show one leaflet of the valve did not move while the other moved freely.In addition, one photograph was received which appeared to show an explanted mechanical heart valve.Blood was present on the device.One leaflet was in the open and one was in the closed position.

• 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: 16954194
• Report Number: 2135147-2023-02184
• Device Sequence Number: 3340077
• Product Code: LWQ
• UDI-Device Identifier: 05414734006552
• UDI-Public: 05414734006552
• 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): 07/21/2023

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: 29MJ-501
• Device Catalogue Number: 29MJ-501
• Device Lot Number: C00005717
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2023
• Supplement Date Received by Manufacturer: 06/26/2023
• Initial Report FDA Received Date: 05/18/2023
• Supplement Report FDA Received Date: 07/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2022
• 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