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

Catalog Number	PRT-23
Medical Device Problem Code	Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Dyspnea (1816); Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	08/23/2023
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
Clinical information: (b)(6).It was reported that on (b)(6) 2018, a 23mm portico valve was successfully implanted in a patient with mitral stenosis and mitral regurgitation.It was noted via transthoracic echocardiogram prior to discharge on (b)(6) 2018, that the patient had mild aortic regurgitation.On (b)(6) 2023, it was noted that the patient had begun to experience significant breathlessness, orthopnea, and nocturnal dyspnea.The patient arrived at the emergency room and was found to be clinically overloaded with decreased breath sounds/crackles in the mid-section, and wheezing.The decision was initially made to administer the patient intravenous lasix and then converted to oral lasix.A transthoracic echocardiogram was performed and revealed preserved let ventricular systolic function, but also moderate aortic regurgitation, mild mitral stenosis, and mild to moderate tricuspid regurgitation.The patient's condition was monitored and noted to have improved over the next few days.On (b)(6) 2023, the patient was discharged.There is no allegation of malfunction against the abbott device or procedure.The events are attributed to the patient's past medical history and fluid overload.
Additional Manufacturer Narrative
An event of central regurgitation, aortic valve regurgitation, and dyspnea was reported.Information from the field indicated that the events are attributed to the patient's past medical history (pre-existing aortic regurgitation) and fluid overload.Based on available information, the cause for the reported event appears to be related to patient condition.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: 17916651
• Report Number: 2135147-2023-04469
• Device Sequence Number: 6782057
• Product Code: NPT
• UDI-Device Identifier: 05415067010728
• UDI-Public: 05415067010728
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P190023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 11/03/2023

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: 02/01/2020
• Device Catalogue Number: PRT-23
• Device Lot Number: 6328025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 10/13/2023
• Initial Report FDA Received Date: 10/11/2023
• Supplement Report FDA Received Date: 11/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2018
• 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: Other; Hospitalization
• Patient Sex: Unknown