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

Model Number	FNAV-DS-SM
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	08/19/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2026, an25mm, navitor vision valve was selected for implant using a small flexnav delivery system (ds).The patient has a torturous anatomy.During the procedure, the valve was able to be implanted.Upon removal, non-abbott wire got stuck within the ds and it was unable to be removed.A 0.018 wire down the side of the integrated sheath of ds into the patient's body.The non-abbot wire and ds were then removed together.Post-procedure, small localized pericardial effusion was observed in the right atrium and right ventricle with a largest dimension of 1.8 cm at the right ventricle (rv) and pericardial drainage was performed to resolve the event.The patient was in a recovering condition.
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

• 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: 50847616
• Report Number: 2135147-2026-06390
• Device Sequence Number: 15866040
• Product Code: NPT
• UDI-Device Identifier: 05415067031372
• UDI-Public: (01)05415067031372(17)280430(10)11407292
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/21/2026

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: FNAV-DS-SM
• Device Catalogue Number: FNAV-DS-SM
• Device Lot Number: 11407292
• 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: 08/27/2026
• Initial Report FDA Received Date: 09/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/12/2026
• 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: 80 YR
• Patient Sex: Female