MAUDE Adverse Event Report: Abbott Medical FlexNav Delivery System; Aortic Valve, Prosthesis, Percutaneously Delivered

Model Number	FNAV-DS-SM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)
Date of Event	07/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2026, balloon aortic valvuloplasty (bav) and percutaneous coronary intervention (pci) were performed.At that time, a pericardial effusion was identified, and the transcatheter aortic valve implantation (tavi) procedure was postponed.On 10 july 2026, a 25 mm navitor vision valve was selected for implant using a small flexnav delivery system (ds).The native valve annulus dimensions were reported as 21.3 mm (short axis) and 26.5 mm (long axis).No difficulty implanting the device, including multiple manipulations, was reported.The valve was not resheathed more than two times, and no multiple guidewire or delivery sheath exchanges were reported.Protamine was administered after the procedure.Following the procedure, the patient experienced hypotension, and echocardiography confirmed the presence of pericardial effusion within 48 hours post-procedure.The hypotension was treated with noradrenaline (norepinephrine), which elevated the patient's blood pressure.The implanter believed the hypotension was caused by an increase in pericardial fluid (pericardial effusion).No cardiac tamponade was reported.The cause of the pericardial effusion was unknown.According to the physician, involvement of the right-sided cardiac system was suspected.The pericardial effusion was reported to be located around the right-sided cardiac chambers.The pericardial effusion was managed conservatively with observation.No increase in the effusion was observed during follow-up.Information regarding activated clotting time (act), heparin administration, anticoagulant or antiplatelet therapy, and the largest dimension or distribution of the pericardial effusion was unavailable because abt had not received a signed patient consent form and patient information was unavailable due to patient privacy laws in japan.The user did not believe the abbott device caused the pericardial effusion.The user believed the pericardial effusion was related to a pre-existing injury sustained during the prior pci and bav procedures and that procedural manipulation re-aggravated the site, resulting in renewed leakage.No allegation of malfunction was reported against the 25 mm navitor vision valve.The patient remained hemodynamically stable throughout the procedure.No clinically significant delay was reported, and no initial or prolonged hospitalization due to the event was reported.Operative notes were unavailable because abt had not received a signed patient consent form and patient information was unavailable due to patient privacy laws in japan.Procedural imaging and reports of therapeutic interventions were not available because the physician did not believe the abbott device was the direct cause of the event.The patient's status was reported as stable, and no further increase in the pericardial effusion had been observed during follow-up.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

• 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: 50133645
• Report Number: 2135147-2026-05311
• Device Sequence Number: 21461209
• Product Code: NPT
• UDI-Device Identifier: 05415067031372
• UDI-Public: (01)05415067031372(17)280131(10)11248956
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P190023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Type of Report: Initial
• Report Date (Section B): 08/04/2026

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: 11248956
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2026
• Initial Report FDA Received Date: 08/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/05/2026
• 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: 85 YR
• Patient Sex: Female
• Patient Weight: 112 LB