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

Model Number	NVRO-35
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); Blurred Vision (2137); Movement Disorder (4412)
Date of Event	01/20/2026
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) 2026, a 35mm navitor vision valve was selected for implant using a large flexnav delivery system (ds).A pre-implant balloon aortic valvuloplasty (pre-bav) was performed using an unknown balloon, and it was noted that the balloon was embolized during inflation.During the preparation, valve check revealed misloading of the device.A new 35mm, navitor valve and ds were prepared.During the procedure, on the initial attempt, the valve was not stable, so a recapture was performed; on the second attempt, the valve was positioned at a higher depth, so it was recaptured again.On the third attempt, the valve was able to be implanted at a depth of 6mm on the non-coronary cusp (ncc) and 2mm on the left-coronary cusp (lcc).The patient became hypotensive and was supported by medications to maintain adequate hemodynamics.Post-implant, the patient had blurred vision and gait disturbance, and it was confirmed that the patient had a stroke.No interventions were performed since the patient was outside the window for thrombolytics.The patient had an extended hospitalization.The physician believes that the deployment difficulties were likely attributable to the cause of the stroke.The patient had recovered and discharged.
Event or Problem Description
It was reported that on (b)(6) 2026, a 35mm navitor vision valve was selected for implant using a large flexnav delivery system (ds).A pre-implant balloon aortic valvuloplasty (pre-bav) was performed using an unknown balloon, and it was noted that the balloon was embolized during inflation.During the preparation, valve check revealed misloading of the device.A new 35mm, navitor valve and ds were prepared.During the procedure, on the initial attempt, the valve was not stable, so a recapture was performed; on the second attempt, the valve was positioned at a higher depth, so it was recaptured again.On the third attempt, the valve was able to be implanted at a depth of 6mm on the non-coronary cusp (ncc) and 2mm on the left-coronary cusp (lcc).The patient became hypotensive and was supported by medications to maintain adequate hemodynamics.Post-implant less than 24 hours, the patient had blurred vision and gait disturbance, and it was confirmed that the patient had a stroke.No interventions were performed since the patient was outside the window for thrombolytics.The patient had an extended hospitalization.The physician believes that the deployment difficulties were likely attributable to the cause of the stroke.The patient had recovered and discharged.
Additional Manufacturer Narrative
An event of stroke post implant procedure, and patient effects of hypotension, movement disorder, and blurred vision were reported.A returned device assessment could not be performed as the device remains 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.Based on the information received, the cause of the reported stroke could not be conclusively determined.It is possible due to procedural complications (multiple attempts were made to implant the valve).However, this cannot be confirmed.The reported patient effects appeared to be cascading effects from the reported stroke but cannot be confirmed.The reported unexpected medication and hospitalization were case-specific circumstances as patient was administered to hospital and medication was provided.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• Brand Name: NAVITOR VISION
• 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: 24338760
• Report Number: 2135147-2026-00922
• Device Sequence Number: 18585181
• Product Code: NPT
• UDI-Device Identifier: 05415067045768
• UDI-Public: (01)05415067045768(17)280210
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P190023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2026

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 Model Number: NVRO-35
• Device Catalogue Number: NVRO-35
• Device Lot Number: 10748846
• 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: 01/21/2026
• Supplement Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 02/13/2026
• Supplement Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/10/2025
• 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: FNAV-DS-LG.
• Outcome Attributed to Adverse Event: Life Threatening; Hospitalization; Required Intervention
• Patient Sex: Unknown