MAUDE Adverse Event Report: ABBOTT MEDICAL FLEXNAV DELIVERY SYSTEM; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number	FNAV-DS-SM
Medical Device Problem Codes	Retraction Problem (1536); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device will not be returned for evaluation, the device was reportedly discarded.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).The patient has a prior medical history notable for a biventricular implantable cardioverter-defibrillator (biv icd); therefore, baseline was paced and severe aortic stenosis.Membranous septum measurement was unclear.Fluoroscopy check was confirmed and a pre-implant balloon aortic valvuloplasty (pre-bav) was performed using a 20mm, non-abbott balloon.During the procedure, during the second recapture, the radiopaque tip was not fully retracted into the valve capsule.Upon removal, the ds was deformed and a new 25mm navitor vision valve was loaded for implant using a new small flexnav ds.Fluoroscopy was performed prior to insertion.The valve was able to be implanted in cusp overlap view at a depth of 4mm on the non-coronary cusp (ncc) and 6mm on the left-coronary cusp (lcc).No paravalvular leak (pvl) was noted.Final gradient was 1mmhg.The patient's cardiac rhythm remained unchanged.The patient remained hemodynamically stable throughout the procedure, and there was no clinically significant delay reported.The patient was discharged.
Additional Manufacturer Narrative
An event of retraction problem and material deformation 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.Based on the information received, the cause of the reported retraction problem could not be determined.The damage to valve capsule is consistent with operational difficulty.The reported deformation is possible due to procedural conditions (user techniques handling) contributed to the reported issues.However, this cannot be confirmed.There is no indication of a product quality issue with respect to labeling, design, or manufacturing of the device.

• 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 1789
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 24648893
• Report Number: 2135147-2026-01756
• Device Sequence Number: 18659484
• Product Code: NPT
• UDI-Device Identifier: 05415067031372
• UDI-Public: (01)05415067031372(17)270731(10)11020675
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 11020675
• 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: 02/23/2026
• Supplement Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 03/20/2026
• Supplement Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/28/2025
• 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: NVRO-25.
• Patient Age: 62 YR
• Patient Sex: Female