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

Catalog Number	TF-19A
Medical Device Problem Codes	Device Stenosis (4066); Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); Dyspnea (1816); Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	09/03/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported in a research article, first-in-human: leaflet laceration with balloon mediated annihilation to prevent coronary obstruction with radiofrequency needle (llamacorn) for valve-in-valve transcatheter aortic valve replacement.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.D4: the udi number is not known as the lot number was not provided.Literature attachment: article titled "leaflet laceration with balloon mediated annihilation to prevent coronary obstruction with radiofrequency needle (llamacorn) for valve-in-valve transcatheter aortic valve replacement.
Event or Problem Description
The article, "first-in-human: leaflet laceration with balloon mediated annihilation to prevent coronary obstruction with radiofrequency needle (llamacorn) for valve-in-valve transcatheter aortic valve replacement" was reviewed.The article presented a case study of a 84 yrs old patient with new york heart association (nyha) iii dyspnea and chronic coronary syndromes (ccs) iii angina.It was reported that on an unknown date, a 19mm trifecta valve was implanted.It was then reported the patient presented severe aortic stenosis due to degenerated aortic valve bioprosthesis.Aortic stenosis (as), left ventricular ejection fraction (lvef) 58%, mavg 36 mmhg, dimensionless velocity index (dvi) 0.2, 2d, eoa0.5cm2; 3+ transvalvular ar.Cardiac computed tomography revealed left main coronary artery(lmca) height 8.8 mm, ventricular tachycardia (vtc) 38.8mm.A decision was made to perform a transcatheter valve-in-valve procedure with a 23mm navitor valve in degenerative 21 mm trifecta (abbott) aortic prosthesis.The procedures were performed under general anesthesia in the cardiac catheterization laboratory with fluoroscopic and transoesophageal echocardiogram (tee) guidance.Intravenous unfractionated heparin was administered to an activated clotting time of >300.To prevent coronary obstruction during transcatheter valve-in-valve procedure, the left coronary cusp of the trifecta valve was intentionally perforated with an 0.014" asahi astato wire, followed by sequential ballooning with a 4x20mm abbott trek balloon.Fluoroscopic and tee confirmed leaflet traversalaflet with a post dilation with a true 22 x 45 mm balloon (bd) for inside-out leaflet annihilation.30 day follow up-showed the patient had a successful uncomplicated tavr with no coronary obstruction and no conduction abnormalities necessitating permanent pacemaker implantation, discharged to home and were alive at 30-day follow-up.No patient suffered stroke or vascular complications.In conclusion, llamacorn represents a potential alternative as a modification of unicorn to facilitate the use of sev for valve in valve procedures.Further investigation of llamacorn appears warranted.[anthony c.Camuglia, mbbs, (hons1, monash), mha, (monash), fracp, fcsanz, department of cardiology, princess alexandra hospital, university of queensland, 199 ipswich rd, woolloongabba, brisbane qld 4102, australia.Email: anthony.Camuglia@health.Qld.Gov.Au].

• 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: 20352426
• Report Number: 2135147-2024-04838
• Device Sequence Number: 15453685
• Product Code: LWR
• UDI-Device Identifier: 05414734052016
• UDI-Public: 05414734052016
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/02/2024

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: 09/10/2024
• Initial Report FDA Received Date: 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 84 YR
• Patient Sex: Female