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

Catalog Number	PRT-27
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Endocarditis (1834)
Date of Event	05/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported in a research article, a patient presented with endocarditis approximately four months post-procedure.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device was received for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.
Event or Problem Description
The article, "intracardiac echocardiogram to diagnose infective endocarditis after transcatheter aortic valve-in-valve implantation", was reviewed.The article presented a case study of a 70-year-old male patient history of hypercholesterolemia, obesity, abdominal aortic aneurysm, and cardiac valve surgery.It was reported that on an unknown date, a 27mm portico valve was chosen for an off-label use of valve-in-valve transcatheter aortic valve implantation (viv-tavi) procedure.It was later reported four months post-procedure, the patient presented with fever, dyspnea, and general malaise.Infective endocarditis (ie) was confirmed via intracardiac echocardiogram (ice) under local anesthesia and a mobile echogenicity was noted attached to the valve leaflet, consistent with vegetation.The patient was prescribed antibiotics which successfully treated the endocarditis.The article concluded that with increasing use of viv-tavi or tavi-in-tavi, conventional echocardiographic diagnosis for ie could be more difficult, due to artifacts generated by the metallic materials.Ice can directly visualize the prosthetic valve leaflets inside the metallic stent frames free from any artifacts.Cardiologists should be aware of this diagnostic tool, when conventional imaging methods are non-diagnostic.[the primary and corresponding author was cheuk bong ho, the heart centre, rigshospitalet, copenhagen university hospital, copenhagen, denmark, with corresponding email: bongii2001@gmail.Com].

• 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: 18035656
• Report Number: 2135147-2023-04780
• Device Sequence Number: 7344595
• Product Code: NPT
• UDI-Device Identifier: 05415067012494
• UDI-Public: 05415067012494
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: P190023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/30/2023

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 Catalogue Number: PRT-27
• 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
• Initial Report FDA Received Date: 10/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Male