MAUDE Adverse Event Report: Abbott Medical Masters Series Hemodynamic Plus Valve; Heart-Valve, Mechanical

Model Number	15AHPJ-505
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2021, a 15mm masters series hemodynamic plus aortic valve was chosen for implant.It was then reported on (b)(6) 2026, patient was hospitalized and underwent an unknown procedure.It was not confirmed if the 15mm masters aortic valve was explanted or replaced.
Event or Problem Description
It was reported that on (b)(6) 2021, a 15mm masters series hemodynamic plus aortic valve was chosen for implant.It was then reported on (b)(6) 2026, patient was hospitalized and underwent redo-surgical aortic valve replacement with a 23mm regent mechanical aortic valve to prevent patient-prosthesis mismatch due to patient growth.Patient status was reported recovering well.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
A redo surgical aortic valve replacement due to patient growth and the potential for patient-prosthesis mismatch was reported.A returned device assessment could not be performed as the device 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 all specifications.Based on the available information, the reported redo surgical aortic valve replacement was performed to prevent patient-prosthesis mismatch resulting from patient growth following the initial valve implantation.The event is consistent with patient anatomical changes over time and does not appear to be related to a deficiency of the implanted device.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Codes removed: health effect-clinical code: 4580.Medical device problem code: 3190.

• Brand Name: Masters Series Hemodynamic Plus 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#3007113487; 177 county road b east; st. paul MN 55117 -178
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; +1(651)756-5400
• MDR Report Key: 50018802
• Report Number: 2135147-2026-05076
• Device Sequence Number: 18579916
• Product Code: LWQ
• UDI-Device Identifier: 05415067042972
• UDI-Public: (01)05415067042972(17)240608
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P810002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2026

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 Expiration Date: 06/08/2024
• Device Model Number: 15AHPJ-505
• Device Catalogue Number: 15AHPJ-505
• Device Lot Number: 7037598
• 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: 06/29/2026
• Supplement Date Received by Manufacturer: 09/18/2026
• Initial Report FDA Received Date: 07/27/2026
• Supplement Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/10/2019
• 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; Hospitalization
• Patient Sex: Unknown