MAUDE Adverse Event Report: ABBOTT MEDICAL TENDYNE¿ MITRAL VALVE; PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED

Model Number	TENDV-LP-29L
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	10/10/2025
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
Clinical information: (b)(4) - resolve-mr study, patient site id: (b)(6).It was reported that on (b)(6) 2025, a 29l tendyne mitral valve lp valve was implanted in the patient.On (b)(6) 2025, a massive thrombosis on the mitral valve prothesis was noted.The patient required prolonged hospitalization due this event.The patient was reported passed away.
Additional Manufacturer Narrative
It was reported that the patient underwent tendyne valve implantation in (b)(6) 2025 and a massive thrombosis on valve was noted in (b)(6) 2025.The patient¿s condition deteriorated, progressing to cardiogenic shock and requiring icu admission.The patient was deemed inoperable and passed away on (b)(6) 2025.A more comprehensive assessment, including histopathological examination of the valve tissue could not be performed as the device remained implanted and was not returned for analysis.The device history record was also reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Based on the information available from field and medical review, the patient death appears cardiovascular in nature.The exact cause of the reported valve thrombosis and patient death could not be determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
Event or Problem Description
Clinical information: (b)(6) - resolve-mr study, patient site id: (b)(6).It was reported that on (b)(6) 2025, a 29l tendyne mitral valve lp valve was implanted in the patient.On (b)(6) 2025, a massive thrombosis on the mitral valve prothesis was noted.The patient required prolonged hospitalization due this event.A cardiac surgery was called and the patient was transferred with a diagnosis of cardiogenic shock.The patient was reported passed away.

• 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): ABBOTT MEDICAL REG#3007113487; 177 county road b east; st. paul MN 55117 1789
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 23497000
• Report Number: 2135147-2025-06454
• Device Sequence Number: 9037956
• Product Code: NPU
• UDI-Device Identifier: 05415067032669
• UDI-Public: (01)05415067032669(17)221014
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P240042
• 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,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2026

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: 10/14/2022
• Device Model Number: TENDV-LP-29L
• Device Catalogue Number: TENDV-LP-29L
• Device Lot Number: 8271494
• 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: 10/13/2025
• Supplement Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 11/07/2025
• Supplement Report FDA Received Date: 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/14/2021
• 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: Hospitalization; Death
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 60 KG