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

Model Number	31MJ-501
Medical Device Problem Codes	Fracture (1260); Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Angina (1710); Myocardial Infarction (1969); Cardiac Tamponade (2226); Thrombosis/Thrombus (4440); Mitral Valve Insufficiency/ Regurgitation (4451)
Date of Event	05/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Clinical information: (b)(4) - sh device registry, patient site id: (b)(6).It was reported that on (b)(6) 2025, a 31mm masters series mechanical heart valve was successfully implanted in a patient.A postoperative echocardiogram in the intensive care unit (icu) showed severe grade 3-4 mitral regurgitation, leading to reoperation within 24 hours.During reoperation, an attempt to rotate a 31mm non-abbott replacement valve, a rupture occurred.The patient required extracorporeal membrane oxygenation (ecmo) implantation, followed by another operation due to bleeding.Ultrasound again showed abnormalities in the 31mm non-abbott replacement valve, specifically a fixed posterior disc, leading to another reoperation and replacement with a 29mm epic plus mitral valve.On (b)(6) 2025, it's noted that the patient began suffering from cardiac tamponade.Cardiac tamponade was confirmed by transesophageal ultrasound after the patient, who had been progressing favorably, experienced sudden hemodynamic deterioration.Daily ultrasound studies performed at the bedside in the icu did not reveal any pericardial effusion prior to confirming cardiac tamponade.A surgical revision/intervention was performed, but no active bleeding site was noted.The patient remained under ecmo therapy.On (b)(6) 2025, the patient present with acute mitral regurgitation due to a st-elevation myocardial infarction.A coronarography revealed a severe lesion in the mid-circumflex artery with no other significant anomalies.It was noted that the patient presented with typical angina.A catheterization was performed and revealed significant stenosis of the left main coronary artery to a thrombus of unknown origin.Mitral regurgitation was diagnosed by echocardiography.The decision was made to perform a percutaneous intervention of the mid-circumflex artery and left main coronary artery.The cardiac tamponade was caused by anticoagulation and platelet dysfunction due to ecmo, along with factor xiii deficiency.The mitral regurgitation was of ischemic origin, caused by rupture of the papillary muscle.The thrombus at the origin of the left main coronary artery was believed to be caused by va-ecmo (venoarterial extracorporeal membrane oxygenation), which can lead to aortic root thrombus formation due to insufficient forward flow across the aortic valve, resulting in blood stasis and clot formation.The implanting physician attributed the st-elevation myocardial infarction (stemi) to the patient¿s multiple cardiovascular risk factors, including hypertension, dyslipidemia, obesity, and active smoking.The patient¿s typical angina symptoms were attributed to coronary lesions.The patient was discharged after a 3-month hospital stay and is in good clinical condition, although motor function is still recovering due to the prolonged hospitalization.
Additional Manufacturer Narrative
The device remains implanted in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event involving central regurgitation and valve fracture was reported.A more comprehensive assessment, including histopathological examination of the valve tissue could not be performed as the device remains implanted and was not returned for analysis.The device history record was reviewed and confirmed that all manufacturing and inspection processes were completed and the product met specifications.However, the exact cause of the reported event could not be conclusively determined.The patient outcomes appear to be a cascade of events following the initial regurgitation, but this cannot be conclusively detremined.The reported surgical intervention was result of case specific circumstances.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• 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: 22829913
• Report Number: 2135147-2025-04612
• Device Sequence Number: 4578054
• Product Code: LWQ
• UDI-Device Identifier: 05415067045072
• UDI-Public: (01)05415067045072(17)280507
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 31MJ-501
• Device Catalogue Number: 31MJ-501
• Device Lot Number: C00020952
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2025
• Supplement Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 08/18/2025
• Supplement Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/08/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 31MM CARBOMEDICS OPTIFORM.; 31MM MASTERS SERIES MECHANICAL HEART VALVE.
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention; Disability
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 100 KG