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

Model Number	NVTR-29
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2026
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 (b)(6) 2026, a 29mm navitor valve was selected for implant using a large flexnav delivery system (ds).The patient had a heavily calcified annulus.Pre-implant balloon aortic valvuloplasty (pre-bav) was performed using a 23mm, non-abbott balloon.The patient was observed to be hypotensive and recovered by managing with anesthetic support.During the procedure, at the time of deployment, the valve was positioned at 3mm depth across the annulus.Upon release, the valve migrated above the annulus.The valve was pulled up into the ascending aorta using a snare and a new 29mm, navitor vision valve was selected for implant using a large flexnav ds.The valve was able to be implanted.Post-implant, no coronary obstruction with good hemodynamics and no clinically significant delay was reported.The physician believes a combination of the pre-bav balloon not being big enough and significant calcification at the ncc caused the valve to migrate up.The patient was discharged.
Additional Manufacturer Narrative
An event of device migration upon release was reported.A returned device assessment could not be performed as the device remains 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.Based on the information received, the exact cause of the reported device migration could not be determined.It is possible that the anatomical factor (heavily calcified annulus) may have contributed to device migration, however this cannot be confirmed.The surgical intervention was result of valve-in valve implant.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Information from field indicated that the valve was pulled up into the ascending aorta using a snare and a new navitor vision valve was selected for implant.Please note that per instructions for use, artmt600267458-b, "once the valve is fully deployed, repositioning and retrieval of the valve is not possible.Attempted retrieval (e.G., use of a guidewire, snare, or forceps) may cause aortic root, coronary artery, and/or myocardial damage." codes removed: health effect-clinical code: 4582.
Event or Problem Description
It was reported that (b)(6) 2026, a 29mm navitor valve was selected for implant using a large flexnav delivery system (ds).The patient had a heavily calcified annulus.Pre-implant balloon aortic valvuloplasty (pre-bav) was performed using a 23mm, non-abbott balloon.The patient was observed to be hypotensive and recovered by managing with anesthetic support by administering adrenaline.During the procedure, at the time of deployment, the valve was positioned at 3mm depth across the annulus.Upon release, the valve migrated above the annulus.The valve was pulled up into the ascending aorta using a snare and a new 29mm, navitor vision valve was selected for implant using a large flexnav ds.The valve was able to be implanted.Post-implant, no coronary obstruction with good hemodynamics and no clinically significant delay was reported.The physician believes a combination of the pre-bav balloon not being big enough and significant calcification at the ncc caused the valve to migrate up.The patient was discharged.

• 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: 24432322
• Report Number: 2135147-2026-01121
• Device Sequence Number: 10393042
• Product Code: NPT
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P190023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 05/06/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Operator of Device: Health Professional
• Device Expiration Date: 05/16/2026
• Device Model Number: NVTR-29
• Device Catalogue Number: NVTR-29
• Device Lot Number: 9092087
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2026
• Supplement Date Received by Manufacturer: 05/04/2026
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/17/2023
• 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: 84 YR
• Patient Sex: Male