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

Model Number	TENDV-LP-29S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	10/27/2025
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 the on (b)(6) 2025, a 29s tendyne mitral valve lp valve was chosen for a procedure.The valve was implanted in a regular way with good valve function and no interventional gradient.After deployment, the blood pressure was decreased and catecholamines was given to keep pressures up.There was assumption of retroperitoneal bleeding was excluded after (computed tomography (ct) scan (no findings).The patient was put on femoral extracorporeal membrane oxygenation (ecmo) support and taken to intensive care unit.On (b)(6) 2025, the patient showed competent tendyne valve function but suspicion of a elevated left ventricular outflow tract (lvot) gradient.The ecmo could still not be weaned and further follow-up is needed.
Additional Manufacturer Narrative
An event of hypotension was reported.A returned device assessment 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, and the product met all specifications.The cause of the reported incidents could not be conclusively determined.The reported unexpected medical intervention was a result of case-specific circumstances as medication was administered, and the patient was then put on ecmo.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: 23617256
• Report Number: 2135147-2025-06769
• Device Sequence Number: 15975221
• Product Code: NPU
• UDI-Device Identifier: 05415067032652
• UDI-Public: (01)05415067032652(17)270102
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2025

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: 10828826
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2025
• Supplement Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/02/2025
• 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: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 78 KG