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

Model Number	TENDV-RS2
Medical Device Problem Codes	Retraction Problem (1536); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.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 35m tendyne mitral valve lp was chosen for a procedure.During procedure, after the deployment of valve, the patient developed a variable left ventricular outflow tract (lvot) gradient (30-50mmmhg) that could not be mitigated by tension reduction.The physician decided to remove the valve.A tendyne gen ii retrieval system has been prepared by instructions for use (ifu).A good metal to metal and alignment achieved before starting to capture the valve.When rotating the retrieval knob, the valve started to enter into the sheath but then stopped despite retrieval knob rotations.The catheter buckling has been noticed and no pressure applied on the catheter by the physician during the retrieval.The retrieval has been removed and a new tendyne gen ii retrieval system has been prepared following ifu.A good metal to metal and alignment achieved but, extreme resistance noticed during the retrieval knob rotation and the knob was spinning back if hand removed from the wheel.The catheter showed severe bowing during valve retrieval.Finally, the valve has been retrieved.The patient hemodynamic was stable and patient awake the day after.The patient with the same mitral regurgitation (mr) as before the procedure.There was no delay in the procedure.
Additional Manufacturer Narrative
An event of retraction problem and material deformation was reported.The device was returned to abbott for investigation and confirmed the reported sheath deformation.The damaged sheath was removed from the retrieval system and replaced with a test sheath.Using a test valve, retrieval was completed without difficulty.The sheath was sent to science and technology lab for further testing and the material confirmed to meet specifications.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Additionally, the lot was reviewed for similar complaints, and there is no indication of a lot-specific product issue.Based on the available information, the cause of the reported retraction problem appears to be related to the sheath deformation.However, the cause of the sheath damage could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
Event or Problem Description
It was reported that on (b)(6) 2025, a 35m tendyne mitral valve lp was chosen for a procedure.During procedure, after the deployment of valve, the patient developed a variable left ventricular outflow tract (lvot) gradient (30-50mmmhg) that could not be mitigated by tension reduction.The physician decided to remove the valve.A tendyne gen ii retrieval system has been prepared by instructions for use (ifu).A good metal to metal and alignment achieved before starting to capture the valve.When rotating the retrieval knob the valve started to enter into the sheath but then stopped despite retrieval knob rotations.The catheter buckling has been noticed and no pressure applied on the catheter by the physician during the retrieval.The retrieval has been removed and a new tendyne gen ii retrieval system has been prepared following ifu.A good metal to metal and alignment achieved but, extreme resistance noticed during the retrieval knob rotation and the knob was spinning back if hand removed from the wheel.The catheter showed severe bowing during valve retrieval.Finally the valve has been retrieved.The patient hemodynamic was stable and patient awake the day after.The patient with the same mitral regurgitation (mr) as before the procedure.There was no delay in the procedure.

• Brand Name: TENDYNE SYSTEMS
• Common Device Name: PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG#3007113487; 177 county road b east; st. paul MN 55117 1789
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 23222177
• Report Number: 2135147-2025-05686
• Device Sequence Number: 15865090
• Product Code: NPU
• UDI-Device Identifier: 05415067046192
• UDI-Public: (01)05415067046192(17)251112(10)10625816
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P240042
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 06/03/2026

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 Expiration Date: 11/12/2025
• Device Model Number: TENDV-RS2
• Device Catalogue Number: TENDV-RS2
• Device Lot Number: 10625816
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2025
• Supplement Date Received by Manufacturer: 05/29/2026
• Initial Report FDA Received Date: 10/06/2025
• Supplement Report FDA Received Date: 06/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2024
• 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: 80 YR
• Patient Sex: Male