MAUDE Adverse Event Report: ABBOTT MEDICAL SJM TRIFECTA VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Catalog Number	TF-19A
Medical Device Problem Codes	Incomplete Coaptation (2507); Intravalvular regurgitation (4068)
Health Effect - Clinical Code	Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	01/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported in a research article, "chimney stenting for right coronary artery at high-risk of obstruction with flail leaflet in tav-in-sav", seven years post-implant of a 19mm trifecta valve, a patient was hospitalized with acute heart failure and required catecholamine and non-invasive positive pressure ventilation.Transthoracic echocardiography (tte) revealed aortic regurgitation.Some of the complications reported were surgical intervention, hospitalization, aortic regurgitation, unexpected medical intervention, leaflet prolapse.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.
Event or Problem Description
The article, "chimney stenting for right coronary artery at high-risk of obstruction with flail leaflet in tav-in-sav", was reviewed.The article presented a case study of a 92-year-old female with severe aortic stenosis.It was reported that on an unknown date, a 19mm trifecta valve was chosen for implant.It was then reported seven years post-procedure, the patient was hospitalized with acute heart failure and required catecholamine and non-invasive positive pressure ventilation.Transthoracic echocardiography (tte) revealed aortic regurgitation.Transesophageal echocardiography (tee) revealed prolapse of the valve leaflet corresponding to the right coronary cusp and severe transvalvular regurgitation.A decision was made to protect the right coronary artery (rca) via chimney stent procedure from the ostium of the rca above the trifecta valve.A 23mm evolut pro+ valve was then chosen for implant for transcatheter valve-in-valve procedure.[the primary author was jiro sakamoto, tenri hospital, 200 mishimacho, tenri, nara 632-0015, japan].

• Brand Name: SJM TRIFECTA VALVE
• Common Device Name: HEART-VALVE, NON-ALLOGRAFT TISSUE
• 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: 18171927
• Report Number: 2135147-2023-05086
• Device Sequence Number: 7793070
• Product Code: LWR
• UDI-Device Identifier: 05414734052016
• UDI-Public: 05414734052016
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P100029
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/20/2023

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: TF-19A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/31/2023
• Initial Report FDA Received Date: 11/20/2023
• 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 Sex: Female