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

Model Number	TENDV-LP-35M
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	12/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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) 2025, a 35mm tendyne mitral valve lp was implanted in the patient.After successful placement of the valve, a mitral valve supra-annular thrombus became visible.The currently measured activated clotting (act) levels was within target range according to the instructions for use (ifu).A re-administration of heparin dissolved the thrombus.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
It was reported that the patient underwent tendyne valve implantation in (b)(6) 2025 and found thrombosis on valve.A more comprehensive assessment, including histopathological examination of the valve tissue 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.The review determined the process was performed and completed in accordance with abbott specifications and procedures.Based on the information received the cause of the reported valve thrombosis could not be determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• 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 ; 6517565400
• MDR Report Key: 23924534
• Report Number: 2135147-2025-07833
• Device Sequence Number: 18412539
• Product Code: NPU
• UDI-Device Identifier: 05415067032621
• UDI-Public: (01)05415067032621(17)261205
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: P240042
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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,Followup
• Report Date (Section B): 02/19/2026

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-35M
• Device Catalogue Number: TENDV-LP-35M
• Device Lot Number: 10782663
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2025
• Supplement Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 12/30/2025
• Supplement Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/05/2025
• 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