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

Model Number	FNAV-LS-LG
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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) 2023, a 29mm portico valves was selected for an implant.The annular dimension of the native valve was aortic annulus perimeter: 80.6 mm.The implant depth at deployment was noted as 2mm.The implanted depth at release was 1mm.There was sufficient calcium to allow anchoring of the device.The patient did not have a horizontal aorta.During final released of the valve, the valve migrated due to forward tension applied on the flexnav delivery system during final deployment.The valve was not snared.The patient did not have a hypertensive episode at the time of migration.The migrated valve did not block a coronary artery.There was no interaction between the delivery system and the valve.There was no difficulty with deploying or retracting the valve during the procedure.The patient's gradient was noted as 15 mmhg following the implant.A 2nd 29mm portico valve was selected in a valve-in-valve procedure.The patient's status was noted as stable.
Event or Problem Description
It was reported that on (b)(6) 2023, a 29mm portico valves was selected for an implant.The annular dimension of the native valve was aortic annulus perimeter: 80.6 mm.The implant depth at deployment was noted as 2mm.The implanted depth at release was 1mm.There was sufficient calcium to allow anchoring of the device.The patient did not have a horizontal aorta.During final released of the valve, the valve migrated due to forward tension applied on the flexnav delivery system during final deployment.The valve was not snared.The patient did not have a hypertensive episode at the time of migration.The migrated valve did not block a coronary artery.There was no interaction between the delivery system and the valve.There was no difficulty with deploying or retracting the valve during the procedure.The patient's gradient was noted as 15 mmhg following the implant.A 2nd 29mm portico valve was selected in a valve-in-valve procedure.The patient's status was noted as stable.
Additional Manufacturer Narrative
An event of the valve migrating after implant was reported.A returned device assessment could not be performed as the device remained 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.Information from field indicated that the migration was due to forward tension applied on flexnav during final deployment for first operator.The field also indicated that the starting implant depth was 2mm and the final implant depth was 1mm, less than the optimal 3mm depth which could have contributed to the reported event.It was reported that , there was sufficient calcium to allow anchoring of the device.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: FLEXNAV LOADING 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: 16657598
• Report Number: 2135147-2023-01435
• Device Sequence Number: 12578728
• Product Code: NPT
• UDI-Device Identifier: 05415067031440
• UDI-Public: 05415067031440
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• 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,Followup
• Report Date (Section B): 06/01/2023

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 Expiration Date: 09/30/2023
• Device Model Number: FNAV-LS-LG
• Device Catalogue Number: FNAV-LS-LG
• Device Lot Number: 8197515
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/10/2023
• Supplement Date Received by Manufacturer: 05/17/2023
• Initial Report FDA Received Date: 03/31/2023
• Supplement Report FDA Received Date: 06/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2021
• 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 Sex: Male