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

Catalog Number	PRT-25
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Atrial Fibrillation (1729)
Date of Event	11/10/2023
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
Crd_1024 - portico india, patient site id: (b)(6), (b)(4).It was reported that on (b)(6) 2023, a 25mm portico valve was implanted with a small flexnav delivery system.During procedure, a pre-implant balloon aortic valvuloplasty (pre-bav) procedure was performed with an 18mm non-compliant non-abbott balloon.Rapid pacing at 180bpm was required during procedure.A post-bav was performed with a 20mm non-complaint non-abbott balloon.The final implant depth was 3-4mm below the native aortic annulus and post-implant evaluation revealed excellent coaxial implant with no residual gradient and trivial aortic regurgitation.The patient remained hemodynamically stable throughout the procedure.It was then reported on (b)(6) 2023, post-procedure but prior to discharge, the patient experienced atrial fibrillation with fast ventricular rate.A decision was made to administer amiodarone infusion with novel oral anticoagulation therapy.The patient's rhythm reverted to sinus rhythm and was discharged in stable condition.
Additional Manufacturer Narrative
The device was not returned for analysis.An event of atrial fibrillation was reported.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, a cause for the reported atrial fibrillation could not be conclusively determined.The reported unexpected medical interventions are the result of case-specific circumstances.There is no indication of a product quality issue with respect to labeling, design, or manufacturing of the device.

• 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: 21284878
• Report Number: 2135147-2025-00484
• Device Sequence Number: 9339854
• Product Code: NPT
• UDI-Device Identifier: 05415067012487
• UDI-Public: (01)05415067012487(17)250626(10)8567441
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/26/2025
• Device Catalogue Number: PRT-25
• Device Lot Number: 8567441
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/07/2025
• Supplement Date Received by Manufacturer: 02/14/2025
• Initial Report FDA Received Date: 01/31/2025
• Supplement Report FDA Received Date: 02/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/27/2022
• 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: 76 YR
• Patient Sex: Female
• Patient Weight: 81 KG