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

Model Number	NVTR-25
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	02/07/2025
Type of Reportable Event	Death
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 a 25mm navitor transcatheter aortic valve was selected for implant on (b)(6) 2025.The patient's native valve was measured under the following: 22.7mm diameter, 71.4mm perimeter, and an area of 402.7mm^2.The patient had severe calcification on all three cusps.A non-abbott guidewire was positioned in the left ventricle (lv).A pre-dilation was performed with an 18mm non-abbott balloon.After pre-dilation and prior to the delivery system entering the patient, the patient presented with pulseless electrical activity (pea).Advanced cardiac life support (acls) was initiated.Cardiopulmonary resuscitation was performed as part of acls.The valve was positioned at 80% and left in situ.A transthoracic echocardiogram (tte) was performed and showed a pericardial effusion close to the left ventricle.A pericardial drainage was placed with partial reduction of a cardiac tamponade, however the patient remained in pea.The valve was released from the delivery cable.The final implant depth was 3-4mm from the non-coronary cusp (ncc).Extracorporeal circulation (ec) was started and a lv apical lesion was surgically treated.After the surgical repair, a return of spontaneous circulation (rosc) was achieved and maintained.After rosc ec was stopped and removed.A transesophageal echocardiogram (tee) showed the valve was in a stable position with a trivial perivalvular leak.Per the physician, the pericardial effusion was due to the non-abbott guidewire in the lv.The patient was hospitalization in the intensive care unit (icu).On (b)(6) 2025 the patient passed away.The cause of death was the pea.Per the physician, the pea and subsequent death were related to the procedure and patient's comorbidities.
Additional Manufacturer Narrative
The device was not returned for analysis.An event of cardiac arrest and 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.Based on all available information, causes for the reported cardiac arrest could not be conclusively determined.It is possible that they are related to the implant procedure.However, this cannot be confirmed.The reported death appears to be related to the cardiac arrest.The reported unexpected medical intervention was the result of case-specific circumstances.The event and imaging was reviewed by an abbott senior director of medical affairs.The reviewer stated, this appears to be a procedural related death and not related to device malfunction." codes removed: health effect-clinical code: 2226 cardiac tamponade;3271 pericardial effusion.Health effect- impact code: 4624 surgical intervention.

• 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: 21516044
• Report Number: 2135147-2025-01094
• Device Sequence Number: 4590658
• Product Code: NPT
• UDI-Device Identifier: 05415067031587
• UDI-Public: (01)05415067031587(17)261106
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 04/24/2025

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 Model Number: NVTR-25
• Device Catalogue Number: NVTR-25
• Device Lot Number: 10103833
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/07/2025
• Supplement Date Received by Manufacturer: 04/17/2025
• Initial Report FDA Received Date: 03/04/2025
• Supplement Report FDA Received Date: 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/07/2023
• 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: INNOWI WIRE
• Outcome Attributed to Adverse Event: Required Intervention; Disability; Hospitalization; Death
• Patient Age: 84 YR
• Patient Sex: Female