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 Interaction Problem (4001)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Non specific EKG/ECG Changes (1817); Thrombosis/Thrombus (4440); Heart Failure/Congestive Heart Failure (4446)
Date of Event	08/06/2026
Type of Reportable Event	Death
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.
Event or Problem Description
It was reported that on (b)(6) 2026, a 29mm tendyne mitral valve was chosen for implant.Post-procedure, patient had experienced heart failure symptoms and required medication, milrinone, before weaning off and recovering and in physiotherapy.On an unknown date, patient experienced unknown electrocardiogram (ecg) rhythm issues but it was unclear if previously placed epicardial pacer leads were used or effective in pacing the heart.It was then reported on (b)(6) 2026 the patient experienced cardiac arrest and was placed on extra corporeal membranous oxygen (ecmo) therapy on (b)(6) 2026.Post cardiac arrest, patient had severely depressed ejection fraction.A decision was made to place an impella device to vent the left ventricle on (b)(6) 2026.On (b)(6) 2026, an echocardiogram noted the tendyne valve was significantly thrombosed while still on ecmo and with impella.A decision was made to withdraw care and patient passed away on (b)(6) 2026.

• 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: 50548225
• Report Number: 2135147-2026-05964
• Device Sequence Number: 16018914
• Product Code: NPU
• UDI-Device Identifier: 05415067032652
• UDI-Public: (01)05415067032652(17)270708
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/01/2026

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 Model Number: TENDV-LP-29S
• Device Catalogue Number: TENDV-LP-29S
• Device Lot Number: 11103427
• 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: 08/07/2026
• Initial Report FDA Received Date: 09/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/08/2025
• 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: Death
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 167 LB