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

Model Number	NVTR-27
Medical Device Problem Codes	Difficult to Fold, Unfold or Collapse (1254); Migration or Expulsion of Device (1395); Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported on (b)(6) 2025 a 27mm navitor transcatheter aortic valve was selected for implant using a large flexnav delivery system.The patient's annulus was measured with the perimeter at 77.3mm, the diameter at 24.6mm, and the area at 423mm^2.The patient had a bicuspid valve and severe leaflet calcification.The patient's aortic valve angle was 46 degrees.Three attempts were made to pre-dilate the native valve with a 25mm non-abbott balloon but were unsuccessful.On the fourth attempt the balloon ruptured.The patient remained hemodynamically stable.The decision was made to proceed with valve implant.During the procedure, the valve was re-sheathed more than three times.The valve was then positioned in an ideal position, however upon full deployment the valve was observed to under-expand.The final implant depth was 3mm from the non-coronary cusp (ncc).A post-balloon aortic valvuloplasty (bav) was performed with a 23mm non-abbott balloon.The valve expanded more but was still not optimal.The valve also migrated towards the aorta as a result of the post-bav.The decision was made to implant a second 27mm navitor transcatheter aortic valve.The native valve was pre-dilated once more with a 23mm non-abbott balloon.The second valve was deployed but also expanded non-uniformly.Another post-bav was to be performed, however the correct sized-balloon was unavailable.One hour passed before a suitable sized balloon was brought to the hospital to finalize the procedure.Post-bav was performed with adequate expansion and success.The patient did not present with any clinical signs or symptoms.The patient status was stable.Per the physician, the valve expanded non-uniformly due to ineffective pre-dilation.
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.
Additional Manufacturer Narrative
It was reported that the navitor valve was re-sheathed more than three times and was observed to under-expand upon full deployment.A post-balloon aortic valvuloplasty (bav) was performed; the valve expanded more but was still not optimal.Reportedly, the valve migrated towards aorta as a result of the post balloon aortic valvuloplasty.Information from field indicated that the patient had a bicuspid valve and severe leaflet calcification.Please note that per the instructions for use, "the navitor¿/navitor titan¿ valve is designed to be implanted in the native calcific aortic heart valve without open heart surgery and without concomitant surgical removal of the failed native valve." and "do not re-sheath the valve more than two times prior to final valve release.Additional re-sheath attempts may compromise product performance." field also indicated that after three failed attempts to pre-dilate the native valve the balloon ruptured on forth attempt.The device remains implanted and will not return to abbott for analysis.Based on information provided by field, the cause of valve under expansion is consistent with ineffective pre-dilation.Additionally, it is possible that patient anatomical condition (severe calcification) may have contributed to the reported valve under expansion.The reported unexpected medical intervention and surgical intervention were result of post-bav and valve-in-valve procedure.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• 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: 22414502
• Report Number: 2135147-2025-03679
• Device Sequence Number: 18590672
• Product Code: NPT
• UDI-Device Identifier: 05415067031594
• UDI-Public: (01)05415067031594(17)270807
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 08/13/2025

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 Model Number: NVTR-27
• Device Catalogue Number: NVTR-27
• Device Lot Number: 10490949
• 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: 06/12/2025
• Supplement Date Received by Manufacturer: 08/05/2025
• Initial Report FDA Received Date: 07/07/2025
• Supplement Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/07/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: LARGE FLEXNAV DS [FNAV-DS-LG, LOT: 10587679]
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 84 YR
• Patient Sex: Male
• Patient Weight: 85 KG