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

Model Number	25MECJ-502
Medical Device Problem Code	Incomplete Coaptation (2507)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Vomiting (2144); Heart Failure/Congestive Heart Failure (4446)
Date of Event	12/17/2022
Type of Reportable Event	Death
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 on (b)(6) 2022, a 25mm sjm masters series valve expanded cuff was successfully implanted.Prior to the implant procedure, it was reported that the patient was in mild-moderate heart failure condition according to the new york heart association (nyha) functional classification.On (b)(6) 2022, the patient was admitted to the hospital with symptoms of sudden onset breathlessness, which was progressive in nature, vomiting, hypotension, multiple organ dysfunction syndrome (mods), and cardiac arrest.It was determined that the masters valve was stuck in the open position due to a significant increase in the transvalvular gradients across the prosthetic mitral valve.The patient was placed on high inotropic supports and mechanical ventilatory support.While thrombotic treatment was being attempted by administration of streptokinase, the patient expired.The patient's cause of death was multiple organ dysfunction syndrome.No additional information was provided.
Additional Manufacturer Narrative
An event of sudden onset breathlessness, vomiting, hypotension, multiple organ dysfunction syndrome (mods), cardiac arrest and patient death was reported.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• Brand Name: MASTERS SERIES VALVE EXPANDED CUFF
• 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: 16130825
• Report Number: 2135147-2023-00136
• Device Sequence Number: 12643358
• Product Code: LWQ
• UDI-Device Identifier: 05414734006347
• UDI-Public: 05414734006347
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 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: 25MECJ-502
• Device Catalogue Number: 25MECJ-502
• Device Lot Number: C00002035
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/17/2022
• Supplement Date Received by Manufacturer: 04/19/2023
• Initial Report FDA Received Date: 01/10/2023
• Supplement Report FDA Received Date: 04/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Death; Hospitalization; Required Intervention
• Patient Sex: Unknown