MAUDE Adverse Event Report: Abbott Medical Tendyne¿ Mitral Valve; prosthesis, mitral valve, percutaneously delivered

Model Number	TENDV-LP-29S
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Endocarditis (1834)
Date of Event	09/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2026, a 29s tendyne mitral valve lp was implanted in the patient.On (b)(6) 2026, the patient was hospitalized for endocarditis.The patient administered with antibiotics and no modification of the valve.The patient was reported recovering.
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.

• Brand Name: Tendyne¿ Mitral Valve
• Common Device Name: prosthesis, mitral valve, percutaneously delivered
• Manufacturer (Section D): Abbott Medical; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): St. Jude Medical #3014918977; edificio #44 calle 0, ave. 2; el coyol alajuela 1897- 4050; CS 1897-4050
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; +1(651)756-5400
• MDR Report Key: 50897885
• Report Number: 2135147-2026-06506
• Device Sequence Number: 16128757
• Product Code: NPU
• UDI-Device Identifier: 05415067032652
• UDI-Public: (01)05415067032652(17)270305
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P240042
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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
• Report Date (Section B): 09/25/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: TENDV-LP-29S
• Device Catalogue Number: TENDV-LP-29S
• Device Lot Number: 10921883
• 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: 09/03/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/05/2025
• 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
• Patient Sex: Unknown