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

Model Number	NVTR-27
Medical Device Problem Codes	Difficult to Fold, Unfold or Collapse (1254); Migration or Expulsion of Device (1395); Perivalvular Leak (1457)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	05/14/2025
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 27mm navitor valve (sn: (b)(6) was selected for implanted in a patient with severe aortic stenosis.The patient had an aortic angle of 53 degrees and the annular dimensions: annulus dimensions: min/max/avg diameter= 22.7/29.9/26.3mm, area/derived diameter= 520.3mm^2/25.7mm, perimeter/derived diameter: 82.2/26.2mm.The procedure was performed under general anesthesia.The femoral artery was accessed through a standard echo-guided puncture, and a super-stiff pre-shaped non-abbott guidewire was placed in the left ventricle (lv).The aortic valve was pre-dilated with a 22mm non-abbott balloon before the tavi device was introduced.The 27mm valve was selected based on mdct sizing and loaded onto the flexnav delivery system (lot: 10324771) according to the ifu.The tavi device could not cross the stenotic valve due to the steep aortic entry angulation caused by severe aortic valve calcification between the non-coronary cusp and right coronary cusp.The tavi device was retracted from the body.The physicians attempted multiple times to re-position the super-stiff wire in the lv to create a smoother entry angle but were unsuccessful, even with an extra-stiff wire.The original pre-shaped wire was placed back into the lv, followed by balloon valvuloplasty with a 23mm non-abbott balloon (23mm edwards).By the time they attempted to re-introduce the tavi device, the tavi valve had already expired beyond the recommended 45-minute timeframe after being loaded into the delivery system.The tavi device was then replaced with a new set of 27mm navitor valve (sn: (b)(6 and flexnav delivery system (lot: 10324771).The new set of tavi device successfully crossed the stenotic valve and was placed in an acceptable position of 5 to 6mm below the native valve, after a one-time partial resheath.The physician proceeded with deploying the navitor valve after confirming the delivery system was centralized without significant tension.However, the valve gradually descended into the lv after a few heartbeats, resulting in a severe supra-skirtal leak.The physician then performed post-dilatation with a 23mm non-abbott balloon to stabilize the valve and assist valve stent expansion which may shorten the valve stent.Another new set of 27mm navitor valve (sn: (b)(6) and flexnav delivery system (lot: 10324771) was prepared to seal the leak.The third set of tavi device crossed the implanted navitor valve stent with the assistance of a snare catheter.The new navitor valve was then deployed at an acceptable implantation depth, approximately 4 to 5mm below the native annulus, and was stable after complete deployment.The final results showed minimal paravalvular leak and a single-digit residual transvalvular gradient.The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay.The patient is stable.
Event or Problem Description
It was reported that on (b)(6) 2025, a 27mm navitor valve (sn: (b)(6)) was selected for implanted in a patient with severe aortic stenosis.The patient had an aortic angle of 53 degrees and the annular dimensions: annulus dimensions: min/max/avg diameter: 22.7/29.9/26.3 mm, area/derived diameter: 520.3 mm^2/25.7 mm, perimeter/derived diameter: 82.2/26.2 mm.The procedure was performed under general anesthesia.The femoral artery was accessed through a standard echo-guided puncture, and a super-stiff pre-shaped non-abbott guidewire was placed in the left ventricle (lv).The aortic valve was pre-dilated with a 22 mm non-abbott balloon before the tavi device was introduced.The 27 mm valve was selected based on mdct sizing and loaded onto the flexnav delivery system (lot: 10324771) according to the ifu.The tavi device could not cross the stenotic valve due to the steep aortic entry angulation caused by severe aortic valve calcification between the non-coronary cusp and right coronary cusp.The tavi device was retracted from the body.The physicians attempted multiple times to re-position the super-stiff wire in the lv to create a smoother entry angle but were unsuccessful, even with an extra-stiff wire.The original pre-shaped wire was placed back into the lv, followed by balloon valvuloplasty with a 23 mm non-abbott balloon (23 mm edwards).By the time they attempted to re-introduce the tavi device, the tavi valve had already expired beyond the recommended 45-minute timeframe after being loaded into the delivery system.The tavi device was then replaced with a new set of 27 mm navitor valve (sn: (b)(6)) and flexnav delivery system (lot: 10324771).The new set of tavi device successfully crossed the stenotic valve and was placed in an acceptable position of 5 to 6 mm below the native valve, after a one-time partial resheath.The physician proceeded with deploying the navitor valve after confirming the delivery system was centralized without significant tension.However, the valve gradually descended into the lv after a few heartbeats, resulting in a severe supra-skirtal leak.The physician then performed post-dilatation with a 23 mm non-abbott balloon to stabilize the valve and assist valve stent expansion which may shorten the valve stent.Another new set of 27 mm navitor valve (sn: (b)(6)) and flexnav delivery system (lot: 10324771) was prepared to seal the leak.The third set of tavi device crossed the implanted navitor valve stent with the assistance of a snare catheter.The new navitor valve was then deployed at an acceptable implantation depth, approximately 4 to 5 mm below the native annulus, and was stable after complete deployment.The final results showed minimal paravalvular leak and a single-digit residual transvalvular gradient.The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay.The patient is stable.
Additional Manufacturer Narrative
An event of valve under-expansion, migration, and paravalvular leak were reported.A returned device assessment could not be performed as the device remained implanted and 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.It was indicated that valve was implanted after a one-time partial resheath.It was also indicated that the post-dilatation was performed with non-abbott balloon to stabilize the valve and assist valve stent expansion which may shorten the valve stent, may have contributed to reported event of paravalvular leak.The cause of the reported under-expansion could be due to patient condition(calcification).However, this could not be confirmed.The cause of the reported migration appears to be due to the valve under-expansion.The reported unexpected medical interventions and surgery are results of case-specific circumstances, as the valve was snared, another device was implanted valve-in-valve, and post-implant valvuloplasty was performed.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• 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: 22159150
• Report Number: 2135147-2025-02966
• Device Sequence Number: 12972242
• Product Code: NPT
• UDI-Device Identifier: 05415067031594
• UDI-Public: (01)05415067031594(17)260104
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 07/29/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/04/2026
• Device Model Number: NVTR-27
• Device Catalogue Number: NVTR-27
• Device Lot Number: 8853848
• 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: 05/14/2025
• Supplement Date Received by Manufacturer: 07/09/2025
• Initial Report FDA Received Date: 06/06/2025
• Supplement Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/05/2023
• 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: Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male