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

Model Number	TENDV-LP-29L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/09/2025
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
It was reported that on (b)(6) 2025, a 29l tendyne mitral valve lp was implanted in the patient.On (b)(6) 2025, the patient was reported passed away.
Event or Problem Description
It was reported that on (b)(6) 2025, a 29l tendyne mitral valve lp was chosen for implant in the patient who had been hospitalized prior to the procedure.During procedure, there were no complications related to the tendyne system including the tendyne delivery system.There was some complication with the trans mitral access and getting above the mitral valve, however this did not lead to harm.The valve was implanted.The following day after the procedure ((b)(6) 2025), the patient was reported passed away.The cause of death was complications from other medical issues.The physician stated that the cause of death was exacerbation of other disease process and not related to the tendyne system.
Additional Manufacturer Narrative
It was reported that the patient passed away on the following day of successful tendyne implant.Information from field indicated that the patient had been hospitalized prior to the procedure and that there was some complication with the trans mitral access and getting above the mitral valve, however this did not lead to harm.The device remained implanted and will not return to abbott for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Request was made for operative notes surrounding the case; however, this information was not supplied by the site.Based on the information received, the patient death was attributed to complications from other medical issues and not related to the tendyne device.However, the exact cause of 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.

• 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: 23924551
• Report Number: 2135147-2025-07835
• Device Sequence Number: 18402444
• Product Code: NPU
• UDI-Device Identifier: 05415067032669
• UDI-Public: (01)05415067032669(17)270402
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2026

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-29L
• Device Catalogue Number: TENDV-LP-29L
• Device Lot Number: 10966025
• 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: 12/10/2025
• Supplement Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 12/30/2025
• Supplement Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/02/2025
• 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