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

Model Number	PRT-29
Medical Device Problem Code	Perivalvular Leak (1457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2022
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) 2021, a 29mm portico valve was implanted into a patient.On (b)(6) 2022, the patient had endocarditis on the mitral valve and a large vegetation on the left ventricular outflow tract.An echocardiogram performed revealed moderate to severe paravalvular leak of the portico valve, however this was most likely due to the left ventricular outflow tract (lvot) calcium and the vegetation around the area.The surgeon said nothing was wrong with the portico valve, but that it had to be removed to access and replace the mitral valve, remove all the vegetation, replace the aortic valve, and perform a root replacement due to the damage occurred do to removing the vegetation and the tavi valve.The patient remained hemodynamically stable throughout the procedure.No additional information was provided.
Additional Manufacturer Narrative
An event of paravalular leak was reported.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Information from the field indicated that there was endocarditis on the mitral valve with a large vegetation in the lvot.It was indicated that nothing was wrong with the portico valve, but that it had to be removed to be able to access and replace the mitral valve.The cause of the paravalular leak was reported to be due to calcium in the lvot and on the mitral valve.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• Brand Name: PORTICO
• 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: 15714790
• Report Number: 2135147-2022-01888
• Device Sequence Number: 4873412
• Product Code: NPT
• UDI-Device Identifier: 05415067012500
• UDI-Public: 05415067012500
• 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: 2021
• Device Explanted Year: 2022
• 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): 01/19/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/02/2022
• Device Model Number: PRT-29
• Device Catalogue Number: PRT-29
• Device Lot Number: 7450939
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/09/2022
• Supplement Date Received by Manufacturer: 01/14/2023
• Initial Report FDA Received Date: 11/02/2022
• Supplement Report FDA Received Date: 01/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2020
• 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: 81 YR
• Patient Sex: Male