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

Model Number	TENDV-SP-39M
Medical Device Problem Code	Difficult to Fold, Unfold or Collapse (1254)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device remains implanted in patient.The device will not be returned 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 39mm tendyne mitral sp valve was selected for implant.No issues were reported during valve loading and the valve did not have difficulty closing completely.During deployment, the valve had difficulty opening completely.After correct placement of the valve, "an incomplete expansion of the valve became visible." there was "possible entanglement of the anterior leaflet tip." however, the leaflets were fully functional and there was no transvalvular gradient and no paravalvular leak noted.The valve was implanted and was reported to remain implanted in good position.The patient was reported to be recovering.
Additional Manufacturer Narrative
An event of incomplete expansion of valve during placement and "possible entanglement of the anterior leaflet tip" was reported.Also reported that the leaflets were fully functional and there was no transvalvular gradient and no paravalvular leak noted.A returned device assessment could not be performed as the device remains implanted was not returned for analysis.Based on the information received, the cause of the reported valve under-expansion could not be conclusively determined.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
Event or Problem Description
N/a.

• 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: 23089662
• Report Number: 2135147-2025-05276
• Device Sequence Number: 9711091
• Product Code: NPU
• UDI-Device Identifier: 05415067032546
• UDI-Public: (01)05415067032546(17)261205
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• 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): 01/13/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: TENDV-SP-39M
• Device Catalogue Number: TENDV-SP-39M
• Device Lot Number: 10782644
• 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: 08/28/2025
• Supplement Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 09/18/2025
• Supplement Report FDA Received Date: 01/13/2026
• 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
• Patient Age: 81 YR
• Patient Sex: Female