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

Catalog Number	19AGN-751
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	12/12/2024
Type of Reportable Event	Death
Event or Problem Description
It was reported that on (b)(6) 2024, a 19mm regent aortic mechanical heart valve was selected for implant.After the valve was parachuted down, the handle was removed and the sutures were tied.The valve was not attempted to be rotated.Prior to patient closure, the valve leaflets were intended to be tested for mobility.However, it was discovered that one of the leaflets was missing.The holder handle was fully inserted into the orifice at 90 degrees.The leaflet had dislodged in one piece and was recovered from the patient.The valve was explanted and a new 21mm regent aortic mechanical heart valve was implanted as the same size was not available.Post-operatively, the patient remained on ventilator support.On (b)(6) 2024, the patient stopped making urine and was not holding blood pressure.Therefore, intra-aortic balloon was inserted to augment the blood pressure.On (b)(6) 2024, the patient was reported to have passed away.The cause of death was reported as unknown.The 21mm regent valve remains implanted in the patient.However, the patient alleged that the 19mm valve contributed to the patient passing and that the 21mm regent valve did not contribute to the patient passing.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of leaflet dislodgment, hypotension, and death was reported.One image and two videos received from the field showed one leaflet to be dislodged from the valve.The valve with the dislodged leaflet were returned to abbott for a detailed inspection and evaluation.The device confirmed to meet functional specification with no damage or anomalies observed with the device.A review of the device history record confirmed that the valve was manufactured according to all required specifications and procedures.This included an assessment of the leaflet and orifice dimensional matching data, which was found to be compliant with the established requirements.Additionally, the review ensured that each manufacturing and inspection operation was performed and completed in accordance with abbott specifications, including all control measures and functional testing to detect any imperfections in the valve¿s construction.Based on the available information, the exact mechanism that caused the leaflet dislodgement in this case could not be conclusively determined.The cause of the reported death and hypotension 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: REGENT 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: 21093909
• Report Number: 2135147-2025-00177
• Device Sequence Number: 20989922
• Product Code: LWQ
• UDI-Device Identifier: 05414734005869
• UDI-Public: (01)05414734005869(17)280320(10)C00010131
• 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: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2025

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: 19AGN-751
• Device Lot Number: C00010131
• 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: 12/17/2024
• Supplement Date Received by Manufacturer: 02/25/2025
• Initial Report FDA Received Date: 01/07/2025
• Supplement Report FDA Received Date: 03/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2023
• 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
• Patient Sex: Unknown