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

Model Number	NVTR-23
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Heart Block (4444)
Date of Event	04/14/2025
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 23mm navitor valve was chosen for implantation, utilizing a small flexnav.The patient presented with atrial fibrillation (a fib) and right bundle branch block (rbbb) with a membranous septum length of 3.7.The valve was implanted at a depth of 3mm non-coronary cusp (ncc) and 4mm on left coronary cusp (lcc).During the procedure, the patient experienced a heart block.On (b)(6) 2025, a permanent pacemaker was implanted.The patient required prolonged hospital stay for monitoring of rhythm.It was reported that the patient was stable and discharged.
Event or Problem Description
Subsequent to the previously filed report, additional information was received: on (b)(6)2025, during the procedure, to treat the heart block, a temporary pacemaker was placed.
Additional Manufacturer Narrative
An event of heart block was reported.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.It was indicated that the patient had atrial fibrillation and right bundle branch block with a membranous septum which may have contributed to the reported event.The final implant depth was 4 mm from the non-coronary cusp.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Based on all available information, a cause for the reported heart block could not be conclusively determined.It is possible that the event is related to the patient condition prior to implant.However, this cannot be confirmed.The reported unexpected medical intervention was under case-specific circumstances, as temporary pacemaker was implanted for heart block.There is no indication of a product quality issue with respect 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: 22020393
• Report Number: 2135147-2025-02524
• Device Sequence Number: 21208531
• Product Code: NPT
• UDI-Device Identifier: 05415067031570
• UDI-Public: (01)05415067031570(17)251024
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 06/26/2025

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 Expiration Date: 10/24/2025
• Device Model Number: NVTR-23
• Device Catalogue Number: NVTR-23
• Device Lot Number: 8757054
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2025
• Supplement Date Received by Manufacturer: 06/14/2025
• Initial Report FDA Received Date: 05/14/2025
• Supplement Report FDA Received Date: 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/25/2022
• 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: Hospitalization; Required Intervention
• Patient Age: 88 YR
• Patient Sex: Female