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

Model Number	TF-A
Medical Device Problem Codes	Calcified (1077); Device Stenosis (4066)
Health Effect - Clinical Codes	Angina (1710); Aortic Valve Stenosis (1717); Heart Failure/Congestive Heart Failure (4446)
Date of Event	06/05/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Literature attachment: in-stent restenosis percutaneous coronary intervention after chimney stenting during transcatheter aortic valve-in-valve implantation.As reported in a research article, a patient had a valve-in-valve to replace a trifecta valve after about 9 years due to stenosis and calcification.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, "in-stent restenosis percutaneous coronary intervention after chimney stenting during transcatheter aortic valve-in-valve implantation", was reviewed.The research article presents a case study of a 82-year-old woman with prior aortic valve replacement in 2012.It was reported on an unknown date in 2012, a 19mm trifecta valve was implanted.The patient was admitted to the hospital in march 2021 due to heart failure and unstable angina.Transthoracic echocardiogram (tte) showed a degenerated biological aortic prosthesis with severe stenosis, and coronary angiography (ca) showed a severely calcified, critical stenosis in the right coronary artery (rca) ostium.Multislice computed tomography (msct) confirmed severe rca ostium calcification and showed a considerable risk of rca obstruction with transcatheter aortic valve-in-valve implantation (viv-tavi).A decision was made to perform simultaneous viv-tavi and percutaneous coronary intervention (pci) to the rca using a chimney stenting technique with a 4x30mm drug-eluting stent and a 23mm non-abbott transcatheter heart valve.The patient was discharged uneventfully with no report of adverse patient effects.The article concluded while chimney stenting is a bailout technique to treat coronary artery obstruction during transcatheter aortic valve implantation, long-term data on the incidence of in-stent restenosis (isr) and stent thrombosis are unclear.Coronary access and pci after chimney stenting remain challenging, especially in the setting of self-expanding thvs with tall frames and small cells.Finally, in patients at high risk for coronary artery obstruction during tavi, intravascular ultrasound (ivus) facilitates assessment of coronary ostium patency and optimization of chimney stenting and should therefore be considered in these cases.[the primary and corresponding author is oriol rodríguez-leor, hospital universitari germans trias i pujol, badalona, barcelona, spain, with corresponding email: oriolrodriguez@gmail.Com].

• 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: 17195159
• Report Number: 2135147-2023-02736
• Device Sequence Number: 5642856
• Product Code: LWR
• UDI-Device Identifier: 05414734052016
• UDI-Public: 05414734052016
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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): 06/23/2023

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 Model Number: TF-A
• 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: 06/12/2023
• Initial Report FDA Received Date: 06/23/2023
• 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: 82 YR
• Patient Sex: Female