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

Model Number	29MJ-501
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Ischemia (1942); Myocardial Infarction (1969); Renal Failure (2041); Sepsis (2067); Shock (2072); Obstruction/Occlusion (2422); Heart Failure/Congestive Heart Failure (4446); Respiratory Insufficiency (4462)
Date of Event	03/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It is unknown if the device is returning for analysis.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
The patient underwent cardiac surgery on (b)(6) 2025, including septal myomectomy and an attempted mitral valve repair with an annuloplasty ring.Due to intraoperative failure of the repair, the procedure was converted to mitral valve replacement with implantation of a master series mechanical heart valve (abbott / (b)(6).The surgical course was characterized by prolonged and cumulative aortic cross-clamp time of approximately 206 minutes, resulting from an extended initial repair attempt followed by re-clamping for valve replacement.Postoperatively, the patient developed severe hemodynamic instability and cardiogenic shock, with biological markers demonstrating extensive myocardial injury (markedly elevated troponin, ck/ck-mb, and bnp values), consistent with a major perioperative myocardial infarction.The clinical evolution was further complicated by acute heart failure requiring prolonged high-dose inotropic and vasopressor support, respiratory failure, septic shock, and multiorgan dysfunction.The patient required multiple surgical reinterventions, renal replacement therapy, prolonged mechanical ventilation with tracheostomy, gastrostomy, and extended intensive care and hospital stays totaling approximately 11 months.Although survival was achieved, the patient sustained irreversible functional impairment with persistent severe morbidity and long-term immobilization at the time of reporting.

• 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): ABBOTT MEDICAL REG# 2648612; lot 20 b st caguas; caguas 00725 ; * 00725
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 25237019
• Report Number: 2135147-2026-03438
• Device Sequence Number: 13387075
• Product Code: LWQ
• UDI-Device Identifier: 05415067045058
• UDI-Public: (01)05415067045058(17)271023
• Combination Product (Y/N): N
• 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,Consumer,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/20/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 29MJ-501
• Device Catalogue Number: 29MJ-501
• Device Lot Number: C00005310
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/24/2022
• 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; Required Intervention; Disability; Other
• Patient Sex: Unknown