MAUDE Adverse Event Report: ABBOTT MEDICAL FlexNav Delivery System; Aortic Valve, Prosthesis, Percutaneously Delivered

Model Number	FNAV-DS-SM
Medical Device Problem Codes	Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Perforation (2001); Brain Injury (2219); Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	03/16/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported that on (b)(6) 2026, a 25mm navitor vision valve was selected for implant using a small flexnav delivery system (ds).Prior to the procedure, the patient was considered a high-risk patient with severe vascular disease.The patient has a prior medical history of atrial fibrillation (afib) and renal insufficiency.Both femoral accesses were observed to be small and calcified.12fr, non-abbott introducer sheath (is) was inserted through the left carotid vessel.Pre-implant balloon valvuloplasty (pre-bav) was performed using a 20mm, non-abbott balloon.During the procedure, temporary pacemaker placed, the ds was observed to be on the inner curvature due to the access site.In order to centralize, the ds and non-abbott wire were pushed at the same time.Several partial and full recaptures (more than two times) were also performed to centralize the ds, and the valve was able to be implanted.It was reported that manual resheath was performed to retrieve the system.At this moment, the patient's pressure dropped; circumferential pericardial effusion was noted in the apex; progressed to cardiac tamponade due to ventricular laceration.Pericardial drainage was performed and the patient was transferred to surgery.Post-surgical.The patient was in a stable condition.The patient had extended hospitalization.On an unknown date in (b)(6) 2026, the patient was pronounced to be deceased.The user believes that the pericardial effusion was due to the procedure complication (difficulty to centralize the ds due to the selection of access site).The implanter classified this death as being related to the patient's comorbidities.
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 25mm navitor vision valve was selected for implant using a small flexnav delivery system (ds).Prior to the procedure, the patient was considered a high¿risk patient with severe vascular disease.The patient has a prior medical history of atrial fibrillation (afib) and renal insufficiency.Both femoral accesses were observed to be small and calcified.12fr, non-abbott introducer sheath (is) was inserted through the left carotid vessel.Pre-implant balloon valvuloplasty (pre-bav) was performed using a 20mm, non-abbott balloon.During the procedure, temporary pacemaker placed, the ds was observed to be on the inner curvature due to the access site.In order to centralize, the ds and non-abbott wire were pushed at the same time.Several partial and full recaptures (more than two times) were also performed to centralize the ds, and the valve was able to be implanted.It was reported that manual resheath was performed to retrieve the system.At this moment, the patient's pressure dropped; circumferential pericardial effusion was noted in the apex; progressed to cardiac tamponade due to ventricular laceration.Pericardial drainage was performed and the patient was transferred to surgery.Post-surgical.The patient was in a stable condition.The patient had extended hospitalization.On an unknown date in (b)(6) 2026, the patient was pronounced to be deceased.The user believes that the pericardial effusion was due to the procedure complication (difficulty to centralize the ds due to the selection of access site).The implanter classified this death as being related to the patient's comorbidities.
Additional Manufacturer Narrative
An event of off-label use, pericardial effusion, cardiac tamponade, hypotension, 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 specifications.Additionally, a review of the complaint history identified no similar complaints reported from this lot.Based on the available information, the cause of the reported pericardial effusion and cardiac tamponade appear to be related to procedural factor due to left ventricular laceration.However, the cause of the reported laceration could not be conclusively determined.The cause of the reported patient hypotension, cerebral injury, and subsequent death could not be determined.The reported hospitalization, unexpected medical intervention, and surgical intervention were results of case-specific circumstances as pericardiocentesis was performed and the patient was transferred to surgery.The reported off-label use was associated with carotid artery access.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.It should be noted that per the instruction for use (ifu), ¿indications: the flexnav¿ delivery system is indicated for transfemoral or subclavian/axillary delivery of the navitor¿/navitor titan¿ valve.¿ ¿caution: do not re-sheath the valve more than two times.If additional positioning attempts are needed, completely re-sheath the valve and remove the valve from the patient.Use a new valve and delivery system to complete the procedure.¿ codes removed: health effect-clinical code: medical device problem code: 2017.

• Brand Name: FlexNav Delivery System
• Common Device Name: Aortic Valve, Prosthesis, Percutaneously Delivered
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): Abbott Medical Reg#3007113487; 177 county road b east; st. paul MN 55117 -178
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; +1(651)756-5400
• MDR Report Key: 24840975
• Report Number: 2135147-2026-02364
• Device Sequence Number: 13030850
• Product Code: NPT
• UDI-Device Identifier: 05415067031372
• UDI-Public: (01)05415067031372(17)271130(10)11173478
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2026

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: FNAV-DS-SM
• Device Catalogue Number: FNAV-DS-SM
• Device Lot Number: 11173478
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2026
• Supplement Date Received by Manufacturer: 07/20/2026
• Initial Report FDA Received Date: 04/10/2026
• Supplement Report FDA Received Date: 07/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/09/2025
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Age: 81 YR
• Patient Sex: Female