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

Catalog Number	NVTR-25
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fatigue (1849); Heart Block (4444)
Date of Event	10/17/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 a 25mm navitor transcatheter aortic valve was selected for implant on (b)(6) 2024 using a small flexnav delivery system.The length of the membranous septum was 5.5mm.The patient had a history of first-degree heart block.The patient's annular dimensions were measured under the following: diameter at 21.6mm, perimeter at 68.3mm, and left ventricular outflow tract (lvot) at 21.4mm.Pre-dilation was performed with a 20mm non-abbott balloon.The patient's aortic valve angle was 46 degrees.The starting implant depth at 80% was 4mm from the non-coronary cusp (ncc).The depth was also 4mm from the ncc prior to release.During implant the third retainer tab had a delayed release.After the third retainer tab released, the valve was snared out of the aortic valve position towards the aorta.A second 25mm navitor transcatheter aortic valve was implanted valve-in-valve at 5-6mm from the ncc.The patient experienced a drop in blood pressure during the procedure.On the same day the patient went into heart block and a permanent pacemaker was implanted.The patient had prolonged hospitalization for monitoring due to experiencing weakness and fatigue.The patient was discharged on (b)(6) 2024.The patient status was stable.
Additional Manufacturer Narrative
An event for the patient effects of heart block and fatigue was reported.A returned device assessment could not be performed as the device 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 available information, a cause for the reported heart block could not be determined.The reported fatigue is a cascading effect of heart block.The reported hospitalization and surgical intervention were a result of case-specific circumstances.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: 20928499
• Report Number: 2135147-2024-06377
• Device Sequence Number: 8313783
• Product Code: NPT
• UDI-Device Identifier: 05415067031587
• UDI-Public: (01)05415067031587(17)261022(10)10078100
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P190023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 12/30/2024

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 Catalogue Number: NVTR-25
• Device Lot Number: 10078100
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/20/2024
• Supplement Date Received by Manufacturer: 12/13/2024
• Initial Report FDA Received Date: 12/13/2024
• Supplement Report FDA Received Date: 12/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/23/2023
• 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: SMALL FLEXNAV DS [FNAV-DS-SM, LOT: 10376792]
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 87 YR
• Patient Sex: Female