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

Catalog Number	NVTR-23
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Pericardial Effusion (3271)
Date of Event	10/29/2024
Type of Reportable Event	Death
Event or Problem Description
It was reported that on (b)(6) 2024, a 23mm navitor valve was selected for implant.The patients annulus diameter was 19.5mm.During the procedure, a pre-bav was performed using a 20mm balloon, after the pre-bav the patients blood pressure (bp) was noted to be low.When the flexnav ds was introduced, the bp was 85/40.After passing the native annulus, the bp was 60/35.The valve was quickly deployed and cpr was started immediately and lasted for 30min.A pericardial effusion was observed and 600ml of fluid was aspirated.The patient passed away after there were no more options for stabilizing.
Additional Manufacturer Narrative
¿ investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of pericardial effusion, cardiac arrest and patient death was reported.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.It was indicated that during procedure after the pre-bav the patients blood pressure (bp) was noted to be low.A pericardial effusion was observed and 600ml of fluid was aspirated.He 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, the reported pericardial effusion is related to procedural conditions.The reported cardiac arrest appear to be cascading events of the pericardial effusion.A cause for the reported stroke could not be conclusively determined.It is possible that procedural conditions or patient condition contributed to this issue.However, this cannot be confirmed.The reported unexpected medical intervention was the result of case-specific circumstances, as pericardiocentesis and cpr were performed.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.From medical review: "the narrative is consistent with annular rupture due to balloon valvuloplasty.The narrative states that balloon used for valvuloplasty was larger in diameter (20mm) than the annular dimension from the ct (19.5mm), which is against the instruction for use (ifu).This appears to be a procedure mortality and not a device malfunction.".
Event or Problem Description
It was reported that on (b)(6) 2024, a 23mm navitor valve was selected for implant.The patient's annulus diameter was 19.5mm.During the procedure, a pre-bav was performed using a 20mm balloon, after the pre-bav the patients blood pressure (bp) was noted to be low.When the flexnav ds was introduced, the bp was 85/40.After passing the native annulus, the bp was 60/35.The valve was quickly deployed and cpr was started immediately and lasted for 30min.A pericardial effusion was observed and 600ml of fluid was aspirated.The patient passed away after there were no more options for stabilizing.

• 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: 20727190
• Report Number: 2135147-2024-05867
• Device Sequence Number: 12854692
• Product Code: NPT
• UDI-Device Identifier: 05415067031570
• UDI-Public: (01)05415067031570(17)250717(10)8601830
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/17/2025
• Device Catalogue Number: NVTR-23
• Device Lot Number: 8601830
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/29/2024
• Supplement Date Received by Manufacturer: 01/25/2025
• Initial Report FDA Received Date: 11/19/2024
• Supplement Report FDA Received Date: 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/18/2022
• 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: Death; Required Intervention
• Patient Age: 86 YR
• Patient Sex: Female