MAUDE Adverse Event Report: ABBOTT MEDICAL PORTICO TRANSCATHETER AORTIC VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number	PRT-25
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Perivalvular Leak (1457)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	02/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2023, a 25mm portico valve was chosen for implant using a small flexnav delivery system.Pre-procedural imaging was performed and showed a severely calcified aortic valve annulus.A balloon aortic valvuloplasty was performed using a 22mm balloon catheter.The valve was then positioned at 8mm below the non-coronary cusp and 9mm below the left coronary cusp.After the valve was first attempted to deploy, the valve was functioning normally.After the final deployment, the valve tilted clockwise, causing the left coronary cusp side of the valve to move further down to the left ventricular outflow tract (lvot) at 12 to 14mm below the left coronary cusp.The aortogram indicated moderate to severe aortic regurgitation.A post balloon valvuloplasty was performed with a 22mm balloon but failed to mitigate the leak.A second 25mm portico valve was implanted successfully in a valve in valve procedure.The final evaluation showed good hemodynamic results with no trans-aortic valve gradient or trace regurgitation.The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay.The patient was reported as stable.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of valve migration and moderate to severe aortic regurgitation was reported.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
Event or Problem Description
It was reported that on 27 february 2023, a 25mm portico valve was chosen for implant using a small flexnav delivery system.Pre-procedural imaging was performed and showed a severely calcified aortic valve annulus.A balloon aortic valvuloplasty was performed using a 22mm balloon catheter.The valve was then positioned at 8mm below the non-coronary cusp and 9mm below the left coronary cusp.After the valve was first attempted to deploy, the valve was functioning normally.After the final deployment, the valve tilted clockwise, causing the left coronary cusp side of the valve to move further down to the left ventricular outflow tract (lvot) at 12 to 14mm below the left coronary cusp.The aortogram indicated moderate to severe aortic regurgitation.A post balloon valvuloplasty was performed with a 22mm balloon but failed to mitigate the leak.A second 25mm portico valve was implanted successfully in a valve in valve procedure.The final evaluation showed good hemodynamic results with no trans-aortic valve gradient or trace regurgitation.The patient remained hemodynamically stable throughout the procedure and there was no clinically significant delay.The patient was reported as stable.Subsequent to the initially filed report, the following information was received that the perimeter of the annulus was determined to be 24.0mm, the area of the device was determined to be 23.6mm, and the supra-annular perimeter was determined to be 22mm.It was noted that the patient had a horizontal diameter as the aortic angulation was measured to be 53 degrees.There was no reported tension in the delivery system at the time of deployment.After the valve migrated, it remained in the aortic annulus and did not block any coronary arteries.The second valve was implanted in a non-emergent procedure to minimize the regurgitation.

• Brand Name: PORTICO TRANSCATHETER AORTIC VALVE
• Common Device Name: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL #3014918977; edificio #44 calle 0, ave. 2; el coyol alajuela 1897- 4050; CS 1897-4050
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16594597
• Report Number: 2135147-2023-01297
• Device Sequence Number: 3021776
• Product Code: NPT
• UDI-Device Identifier: 05415067012487
• UDI-Public: 05415067012487
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: P190023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 05/30/2023

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: 07/25/2025
• Device Model Number: PRT-25
• Device Catalogue Number: PRT-25
• Device Lot Number: 8617222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/27/2023
• Supplement Date Received by Manufacturer: 05/15/2023
• Initial Report FDA Received Date: 03/22/2023
• Supplement Report FDA Received Date: 05/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2022
• 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: 69 YR
• Patient Sex: Female
• Patient Weight: 60 KG