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

Model Number	TENDV-LP-33S
Medical Device Problem Codes	Perivalvular Leak (1457); Off-Label Use (1494)
Health Effect - Clinical Code	Hemolysis (1886)
Date of Event	06/23/2025
Type of Reportable Event	Serious Injury
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 33s tendyne mitral valve lp was implanted with a small tendyne apical pad.On (b)(6) 2025, a hemolysis had occurred due to perivalvular leak (pvl).On (b)(6) 2025, a re-tensioning was done successfully.And no pvl left.
Additional Manufacturer Narrative
An event of hemolysis and perivalvular leak 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 defined manufacturing specifications.Based on the information received, the cause of the reported hemolysis and perivalvular leak could not be conclusively determined.The reported off-label use appears to be related to user re-tensioning the device after it has been trimmed.The reported hospitalization and surgical intervention were results of case-specific circumstances, as the tether length was adjustment after it trimmed.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: 23209220
• Report Number: 2135147-2025-05627
• Device Sequence Number: 13119945
• Product Code: NPU
• UDI-Device Identifier: 05415067032591
• UDI-Public: (01)05415067032591(17)261205
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: TENDV-LP-33S
• Device Catalogue Number: TENDV-LP-33S
• Device Lot Number: 10782768
• 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: 09/09/2025
• Supplement Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 10/03/2025
• Supplement Report FDA Received Date: 12/12/2025
• 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; Hospitalization
• Patient Age: 76 YR
• Patient Sex: Female