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

Model Number	NVTR-27
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2025
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 27mm navitor vision valve was selected for implant using an unknown sized flexnav delivery system (ds).During the procedure, the valve was able to be implanted successfully.The valve was noted to have migrated towards aortic direction.The physician believes that the patient or user experienced adverse health consequences due to the performance of the product.The patient was stable.
Event or Problem Description
It was reported that on (b)(6) 2025, a 27mm navitor vision valve was selected for implant using a large flexnav delivery system (ds).The patient¿s minimum annulus diameter was measured to 19.8mm.Pre-implant balloon aortic valvuloplasty (pre-bav) was performed using a 20mm, non-abbott balloon.During the procedure, the valve was able to be implanted at a depth of 0mm both on the non-coronary cusp (ncc) and left-coronary cusp (lcc).The valve was noted to have migrated towards aortic direction.The valve was attempted to snare using a 25mm, non-abbott device following a 23mm, non-abbott valve was able to be implanted.The physician believes that the patient or user experienced adverse health consequences due to the performance of the product.The patient¿s status was recovering.
Additional Manufacturer Narrative
An event of valve migration, and improper or incorrect procedure or method were 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 specifications.Based on the available information, the cause of the reported migration could not be conclusively determined.It is possible that patient and procedural conditions, such as "little calcium" and implanting difficulties, contributed to the reported event; however, this cannot be confirmed.The reported improper or incorrect procedure or method was due to snaring the valve post-implant.The reported unexpected medical intervention was result of case-specific circumstances: as valve was snared.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Codes removed: health effect-clinical code: 4580; health effect- impact code: 4648 codes added: health effect-clinical code: 4582 health effect- impact code: 4641 medical device problem code: 2017.

• 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: 23687387
• Report Number: 2135147-2025-07043
• Device Sequence Number: 9521474
• Product Code: NPT
• UDI-Device Identifier: 05415067031594
• UDI-Public: (01)05415067031594(17)261017
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: NVTR-27
• Device Catalogue Number: NVTR-27
• Device Lot Number: 10077548
• 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: 11/06/2025
• Supplement Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/18/2023
• 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
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 86 KG