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

Catalog Number	PRT-25
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Intravalvular regurgitation (4068)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	06/30/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6)2023, a 25mm portico valve (serial (b)(6)) was chosen for implant using a flexnav delivery system (lot 8359430) during a transcatheter aortic valve implantation.The patient did not have a horizontal aorta.There was sufficient calcium to allow sealing, and the annulus diameter was 24.1mm.A pre-dilatation was performed with a 22mm balloon.The valve was implanted at a depth of 2-3mm.There was no difficulty deploying the valve, and there was no tension in the delivery system at the time of final deployment.All three valve retainer tabs were confirmed via imaging to be released prior to removal of the delivery system.An echocardiogram was performed, and the valve had migrated and a transvalvular leak was present.The cause of the migration was believed to be due to calcium.The valve did not block a coronary artery.Another 25mm portico valve (serial (b)(6)) was implanted via valve-in-valve procedure using another flexnav delivery system (lot 8282305) and was slightly lower at a depth of 4mm.A post-dilatation was performed with a 22mm balloon due to valve under expansion.The mean gradient was 5mmhg, and there was trace perivalvular leak.It was reported that the valve was in the optimal position and was a successful implant.Fifteen minutes post procedure, the patient went into cardiorespiratory arrest.Cardiopulmonary resuscitation was performed for 40 minutes but was unsuccessful.The patient passed away.It was reported that there was no presence of bleeding or cardiac tamponade.
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 was reported.Possible contributing factors for valve migration are intra-procedural difficulties, implant depth, annular calcium distribution, and deployment or retraction difficulties.Information from the field indicated sufficient calcium with an implant depth of 2-3mm.The field also indicated that the patient did not have a horizontal aorta and that there was no tension on the delivery system at the time of final deployment.Information from the field indicated that the correct size valve was selected for the implant procedure.A returned device assessment could not be performed as the device remains implanted and is 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 root cause of the reported incident could not be conclusively determined but the calcium in the anatomy may have contributed to the reported anatomy.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 30 june 2023, a 25mm portico valve (serial (b)(6)) was chosen for implant using a flexnav delivery system (lot 8359430) during a transcatheter aortic valve implantation.The patient did not have a horizontal aorta.There was sufficient calcium to allow sealing.The aortic annulus perimeter was 71.8mm, the area was 389.9mm^2, and the average diameter was 22.6mm.A pre-dilatation was performed with a 22mm balloon.The valve was implanted at a depth of 2-3mm.There was no difficulty deploying the valve, and there was no tension in the delivery system at the time of final deployment.All three valve retainer tabs were confirmed via imaging to be released prior to removal of the delivery system.An echocardiogram was performed, and the valve had migrated to the sinus of valsalva and a transvalvular leak was present.The cause of the migration was believed to be due to calcium.The valve did not block a coronary artery.Another 25mm portico valve (serial (b)(6)) was implanted via valve-in-valve procedure using another flexnav delivery system (lot 8282305) and was slightly lower at a depth of 4mm.A post-dilatation was performed with a 22mm balloon due to valve under expansion.The mean gradient was 5mmhg, and there was trace perivalvular leak.It was reported that the valve was in the optimal position and was a successful implant.Fifteen minutes post procedure, the patient went into cardiorespiratory arrest.Cardiopulmonary resuscitation was performed for 40 minutes but was unsuccessful.The patient passed away.It was reported that there was no presence of bleeding or cardiac tamponade.

• 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: 17398417
• Report Number: 2135147-2023-03197
• Device Sequence Number: 5955361
• Product Code: NPT
• UDI-Device Identifier: 05415067012487
• UDI-Public: 05415067012487
• Combination Product (Y/N): N
• 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): 08/29/2023

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: 04/05/2025
• Device Catalogue Number: PRT-25
• Device Lot Number: 8444124
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/01/2023
• Supplement Date Received by Manufacturer: 08/22/2023
• Initial Report FDA Received Date: 07/26/2023
• Supplement Report FDA Received Date: 08/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2022
• 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: Death; Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female