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

Model Number	NVTR-23
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on 27 may 2026, a 23mm, navitor valve was selected for implant using a flexnav delivery system (ds).The patient has a prior medical history of peripheral vascular disease and arteriotomies in the access.Right femoral was selected as the access site.Calcification was observed in the access site, upon insertion of the first proglide, significant difficulty was felt while puncturing.After placement of the first proglide, the femoral artery ruptured and an unspecified peripheral balloon was used to control the bleeding.An arterial dissection was required to advance the ds.The valve and ds were prepared; during the procedure, on the first deployment attempt, it appeared that the navitor vision stent had broken; the valve was recaptured twice due to positioning issue.At this point, the valve capsule did not fully recaptured.All necessary maneuvers were performed without success in recapturing the valve, resulting in deploying the valve in the descending aorta.A second unspecified valve was selected for implant and advanced through the descending aorta.The valve was able to be implanted successfully without complications.The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay reported.Two days later, the patient was reported to be discharged.
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.

• 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: 25566373
• Report Number: 2135147-2026-04256
• Device Sequence Number: 15955712
• Product Code: NPT
• UDI-Device Identifier: 05415067031570
• UDI-Public: (01)05415067031570(17)260709
• 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: 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
• Report Date (Section B): 06/19/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/09/2026
• Device Model Number: NVTR-23
• Device Catalogue Number: NVTR-23
• Device Lot Number: 9165887
• 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: 05/27/2026
• Initial Report FDA Received Date: 06/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/10/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NVTR-23.
• Patient Sex: Female