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

Model Number	NVRO-23
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Arrhythmia (1721); High Blood Pressure/ Hypertension (1908); Heart Block (4444)
Date of Event	06/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It is unknown if the device is returning for analysis.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
Clinical information: crd_1066 - envision ide study, patient site (b)(6).It was reported that on (b)(6) 2025, a 23mm navitor vision valve was chosen for implant using a small flexnav delivery system.The final implant depth at non-coronary cusp (ncc) was 2.9mm and left coronary cusp (lcc) was 3.1mm.The patient developed a left bundle branch block (lbbb) and an episode of nocturnal hypertension post-procedure.No treatment was required for the lbbb as it was resolved the following day.Aldactone was administered to treat the hypertension.On 04 july 2025, the patient experienced palpitation and epigastric pain and the metoprolol dose was decreased.
Additional Manufacturer Narrative
An event of complete heart block, arrhythmia, and hypertension persisted post procedure was 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 available information, the cause of the reported complete heart block, arrhythmia, and hypertension could not be conclusively determined.It is possible procedural conditions and/or patient condition contributed to the incidents.However, this cannot be confirmed.The reported unexpected medical intervention was a result of case-specific circumstances as medication was administered.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• 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: 25060118
• Report Number: 2135147-2026-02935
• Device Sequence Number: 21182023
• Product Code: NPT
• UDI-Device Identifier: 05415067045805
• UDI-Public: (01)05415067045805(17)270306
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2026

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-23
• Device Catalogue Number: NVRO-23
• Device Lot Number: 10268931
• 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: 04/07/2026
• Supplement Date Received by Manufacturer: 05/03/2026
• Initial Report FDA Received Date: 05/01/2026
• Supplement Report FDA Received Date: 05/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/06/2024
• 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: 79 YR
• Patient Sex: Female
• Patient Weight: 53 KG