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)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2025
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 valve was chosen for implant using a large flexnav delivery system.The patient's aortic valve angle (av angle from 3mensio) was 61°.A pre-dilation was performed with a 20mm non-abbott balloon.During procedure, the valve implantation had non uniform expansion and also at the left coronary sinus (lcs) the implant was nominal.During preparation for final deployment, the guide was slightly withdrawn to divert the cone of the nose.After several attempts by the clinical specialist and they noted the valve was in the wrong position, but the physician decided to continue the implant and the valve migrated to the ascending aorta.The cause of migration was the excessive level of calcium.A post dilatation was not performed.A new 26mm non-abbott valve was implanted.There was no delay in the procedure and the patient remained hemodynamically stable throughout the procedure.The patient was reported stable.
Additional Manufacturer Narrative
An event of migration or expulsion of device (aortic direction) and valve under-expansion 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 cause for the reported device migration in aortic direction appears to be due to the valve under-expansion.The cause of the reported under-expansion could not be conclusively determined.The reported unexpected medical intervention and surgical intervention were result of case-specific circumstances as medication provided and another valve was implanted (valve in valve).There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• 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: 22289366
• Report Number: 2135147-2025-03283
• Device Sequence Number: 15591309
• Product Code: NPT
• UDI-Device Identifier: 05415067031594
• UDI-Public: (01)05415067031594(17)260611
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• 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): 08/15/2025

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 Expiration Date: 06/11/2026
• Device Model Number: NVTR-27
• Device Catalogue Number: NVTR-27
• Device Lot Number: 9130032
• 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: 05/28/2025
• Supplement Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 06/19/2025
• Supplement Report FDA Received Date: 08/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/12/2023
• 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: Female
• Patient Weight: 39 KG