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 Codes	Low Blood Pressure/ Hypotension (1914); Ventricular Fibrillation (2130)
Date of Event	09/03/2025
Type of Reportable Event	Death
Event or Problem Description
It was reported that on (b)(6) 2025, a 25mm tendyne mitral valve lp was chosen for implant.During the deployment of a tendyne valve the blood pressure of the patient crushed.Patient converted to on pump heart surgery.After successful implantation of the valve the patient was hemodynamically stable with no catecholamines.Suddenly the patient got ventricular fibrillation (v-fib) and could not been resolved even with maximum therapy.The patient was reported passed away.The cause of death was cardiac death after ventricular fibrillation.The implanter mentioned the death was related to valve but related to procedure.
Additional Manufacturer Narrative
The device is not returning 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) 2025, a 25mm tendyne mitral valve lp was chosen for implant.During the deployment of a tendyne valve the blood pressure of the patient crushed.Patient converted to on pump heart surgery.After successful implantation of the valve the patient was hemodynamically stable with no catecholamines.Suddenly the patient got ventricular fibrillation (v-fib) and could not been resolved even with maximum therapy.The patient was reported passed away.The cause of death was cardiac death after ventricular fibrillation.The implanter mentioned the death was not related to valve but related to procedure.
Additional Manufacturer Narrative
An event of low blood pressure during deployment of the tendyne valve was reported.Postoperatively, the patient developed ventricular tachycardia and unfortunately expired.The device was not returned 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.Cine and medical review were performed at abbott, and the tee findings were consistent with left ventricular outflow tract (lvot) obstruction.Based on the information available and medical review, the cause of patient death appears to be procedure related; however, it is difficult to determine with certainty the exact cause.The unexpected medical intervention was result of case-specific circumstance for v-fib but was not resolved even with maximum therapy.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: 23155115
• Report Number: 2135147-2025-05450
• Device Sequence Number: 14756841
• Product Code: NPU
• UDI-Device Identifier: 05415067032621
• UDI-Public: (01)05415067032621(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
• Device Explanted 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): 01/20/2026

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: 10828766
• 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: 09/03/2025
• Supplement Date Received by Manufacturer: 01/12/2026
• Initial Report FDA Received Date: 09/26/2025
• Supplement Report FDA Received Date: 01/20/2026
• 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; Death
• Patient Age: 80 YR
• Patient Sex: Female