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

Catalog Number	NVTR-25
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Aortic Valve Stenosis (1717)
Date of Event	12/25/2024
Type of Reportable Event	Serious Injury
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 25mm navitor valve was selected for implant in a patient with severe aortic stenosis.The anatomical measurements of the patient were: aortic valve angle in 3-cusp view was lao: 40, cran: 7, in rcc-lcc overlapping view: lao: 21, cau: 18, perimeter / perimeter-derived ø: 71.2 / 22.7mm, area / area-derived ø: 385.4 / 22.2mm, min / max ø: 19.3 / 26.7mm, lvot: avg: 23.7, area: 433.5cm2, and perimeter: 75.6mm.During the procedure, the physician performed a percutaneous puncture through the right common femoral artery and inserted a 14f sheath for pre-dilatation with a 20mm non-abbott balloon.The valve was then inserted and advanced to the ascending aorta.The physician targeted an optimal implantation depth around 3-4mm during the valve deployment due to avoiding the leaflet function of the existing mechanical heart valve at mitral valve.However, the annulus end of the valve went up to annulus level, toward the aorta, after full release of three retainer tabs because of the rheumatic aortic stenosis.The valve was positioned stably but the gradient was high, so the physician decided to perform a post-bav and place a second valve.The first valve was snared and pulled above the stj, after which the second 25mm navitor valve was implanted.The physician doesn't believe the patient or user experienced adverse health consequences due to the performance of the product.The patient remained hemodynamically stable throughout the procedure and there is no clinically significant delay in the procedure.The patient is stable.
Event or Problem Description
It was reported that on (b)(6) 2024, a 25mm navitor valve was selected for implant in a patient with severe aortic stenosis.The anatomical measurements of the patient were: aortic valve angle in 3-cusp view was lao: 40, cran: 7, in rcc-lcc overlapping view: lao: 21, cau: 18, perimeter / perimeter-derived ø: 71.2 / 22.7mm, area / area-derived ø: 385.4 / 22.2mm, min / max ø: 19.3 / 26.7mm, lvot: avg: 23.7, area: 433.5cm2, and perimeter: 75.6mm.During the procedure, the physician performed a percutaneous puncture through the right common femoral artery and inserted a 14f sheath for pre-dilatation with a 20mm non-abbott balloon.The valve was then inserted and advanced to the ascending aorta.The physician targeted an optimal implantation depth around 3-4mm during the valve deployment due to avoiding the leaflet function of the existing mechanical heart valve at mitral valve.However, the annulus end of the valve went up to annulus level, toward the aorta, after full release of three retainer tabs because of the rheumatic aortic stenosis.The valve was positioned stably but the gradient was high, so the physician decided to perform a post-bav and place a second valve.The first valve was snared and pulled above the stj, after which the second 25mm navitor valve was implanted.The physician doesn't believe the patient or user experienced adverse health consequences due to the performance of the product.The patient remained hemodynamically stable throughout the procedure and there is no clinically significant delay in the procedure.The patient is stable.
Additional Manufacturer Narrative
An event of migration or expulsion of device associated with aortic direction 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.Additionally, a review of the complaint history identified no similar incidents reported from this lot.Based on the information received, a cause for the reported device migration to the aortic direction could not be determined.The patient effect of aortic valve stenosis appears to be related device migration.The reported unexpected medical interventions 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: 21148816
• Report Number: 2135147-2025-00301
• Device Sequence Number: 21164791
• Product Code: NPT
• UDI-Device Identifier: 05415067031587
• UDI-Public: (01)05415067031587(17)260621(10)9137628
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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): 03/06/2025

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: 06/21/2026
• Device Catalogue Number: NVTR-25
• Device Lot Number: 9137628
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/25/2024
• Supplement Date Received by Manufacturer: 02/25/2025
• Initial Report FDA Received Date: 01/14/2025
• Supplement Report FDA Received Date: 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/22/2023
• 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: 72 YR
• Patient Sex: Female