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 Codes	Stroke/CVA (1770); Low Blood Pressure/ Hypotension (1914); Pulmonary Edema (2020); Renal Failure (2041); Respiratory Insufficiency (4462)
Date of Event	11/13/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that on (b)(6) 2024, a 23mm navitor transcatheter aortic valve (serial: (b)(6) was chosen for implantation utilizing a small flexnav delivery system (lot: 10386009]).Patient was placed on cardiopulmonary bypass.During positioning, the navitor repeatedly dived towards the ventricle making it difficult to place at appropriate depth.Four recaptures were performed before the device was removed and replaced with a new 23mm navitor (serial: (b)(6) and small flexnav delivery system (lot: 10386009).The valve was implanted successfully after one recapture and the patient was reported to be stable.There was no reported clinically significant delay or patient effects.Post procedure, delayed awakening and right upper limb paralysis were observed.An mri was performed and a new acute cerebral infarction was diagnosed.Since patient had history of hypothyroidism, myxedema coma was suspected, and hydrocortisone 100 mg was administered every 8 hours, along with thyroxine 100 g via a gastric tube.On (b)(6), pulmonary infiltration was observed, which subsequently worsened.On the night of (b)(6), the respiratory condition deteriorated, and ct showed findings of pulmonary edema leading to acute respiratory distress syndrome (ards), accompanied by acute renal failure.Subsequently, blood pressure dropped, and patient died on (b)(6).
Additional Manufacturer Narrative
An event for patient effects of stroke, respiratory insufficiency, renal failure, hypotension, pulmonary edema, and death 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 defined manufacturing specifications.Based on the information received, the cause of the reported stroke/cva could be related to multiple recapture attempts during the procedure and/or comorbidities and medical history.The reported death appears to be related to respiratory failure (insufficiency).The reported respiratory insufficiency can lead to pulmonary edema accompanied by acute renal failure and causing hypotension could not be determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.
Event or Problem Description
Subsequent to the previously filed report, additional information was received.Same day post procedure, delayed awakening and right upper limb paralysis were observed.An mri was performed and a new acute cerebral infarction was diagnosed.Since patient had history of hypothyroidism, myxedema coma was suspected, and hydrocortisone 100 mg was administered every 8 hours, along with thyroxine 100 g via a gastric tube.At an unknown point post procedure, the patient was cardioverted for the pre-existing atrial fibrillation.
Additional Manufacturer Narrative
Correction: h1 type of reportable event: the previous supplemental report (2135147-2025-01780-01) incorrectly was selected as serious injury.This was incorrect as there was no change in the reportability from the initial death report (2135147-2025-01780).

• 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: 21778551
• Report Number: 2135147-2025-01780
• Device Sequence Number: 15431366
• Product Code: NPT
• UDI-Device Identifier: 05415067031570
• UDI-Public: (01)05415067031570(17)260508
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 03/22/2026

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: 05/08/2026
• Device Model Number: NVTR-23
• Device Catalogue Number: NVTR-23
• Device Lot Number: 9068036
• 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: 03/11/2025
• Supplement Date Received by Manufacturer: 05/12/2025; 03/22/2026
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 05/20/2025; 03/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/09/2023
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Female