MAUDE Adverse Event Report: ABBOTT MEDICAL NAVITOR TRANSCATHETER AORTIC VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number	NVTR-25
Medical Device Problem Codes	Difficult to Fold, Unfold or Collapse (1254); Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/13/2025
Type of Reportable Event	Death
Event or Problem Description
It was reported that on (b)(6) 2025, a 25mm navitor valve was chosen for a transcatheter aortic valve implantation (tavi) procedure using a small flexnav delivery system.There was severe calcification present to allow anchoring of the device in the opinion of the user.A pre-dilation was performed with a 20mm non-abbott balloon.After the implant, the valve did not fully open (100%) and a post-dilation was performed.At the time of post-dilation valve pop up toward the aorta.A second 25mm navitor valve was implanted.Finally the patient presented hemodynamic deterioration and after more than 20 minutes of rcp (cardiopulmonary resuscitation).Approximately 10 minutes after the procedure, the patient passed away due to comorbidities.
Additional Manufacturer Narrative
An event of valve under-expansion, migration and patient death were reported.A returned device assessment could not be performed as the device remained implanted and 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 under-expansion could be due to patient condition(calcification).However, this could not be confirmed.The cause of the reported migration appears to be due to the valve under-expansion.The patient¿s death may have been influenced by procedural factors and/or underlying comorbidities; however, a definitive cause cannot be determined.The reported unexpected medical interventions and surgery are results of case-specific circumstances, as cpr was performed, another device was implanted valve-in-valve, and post-implant valvuloplasty was performed.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Based on medical review: based on the information provided, the cause of death appears to be consistent with procedural complication in the setting of underlying comorbidities.
Additional Manufacturer Narrative
It is unknown if the device is returning for analysis.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on an unknown date, an unknown size valve was chosen for a transcatheter aortic valve implantation (tavi) procedure using an unknown delivery system.The valve pop up after the implantation and a second tavi was performed.Finally, the patient presented hemodynamic deterioration and after more than 20 minutes of rcp (cardiopulmonary resuscitation), patient died.

• Brand Name: NAVITOR TRANSCATHETER AORTIC VALVE
• Common Device Name: AORTIC VALVE, PROSTHESIS, 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: 23746081
• Report Number: 2135147-2025-07218
• Device Sequence Number: 9428600
• Product Code: NPT
• UDI-Device Identifier: 05415067031587
• UDI-Public: (01)05415067031587(17)261002
• Combination Product (Y/N): N
• Initial Reporter Country: EC
• PMA/510(K) Number: P190023
• 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): 02/17/2026

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 Expiration Date: 10/02/2026
• Device Model Number: NVTR-25
• Device Catalogue Number: NVTR-25
• Device Lot Number: 10044802
• 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: 11/13/2025
• Supplement Date Received by Manufacturer: 02/09/2026
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 02/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/03/2023
• 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: 87 YR
• Patient Sex: Unknown