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

Catalog Number	TF-21A
Medical Device Problem Codes	Device Stenosis (4066); Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Aortic Valve Stenosis (1717); Dyspnea (1816); Fever (1858); Pseudoaneurysm (2605); Heart Block (4444); Aortic Valve Insufficiency/ Regurgitation (4450)
Date of Event	09/10/2024
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.Literature attachment: article titled "aortic dissection extending into the interventricular septum following re-do aortic valve replacement surgery in a patient with takayasu¿s arteritis_ a rare case report.".
Event or Problem Description
The article, "aortic dissection extending into the interventricular septum following re-do aortic valve replacement surgery in a patient with takayasu¿s arteritis: a rare case report" was reviewed.The article presented a case study of a 39-year-old female with a history of mild aortic regurgitation (ar) experienced a worsening of dyspnea for several months, despite receiving treatment with diuretics and arb.The patient had no hypertension nor family history of cardiovascular disease.Examination revealed grade iii/vi to-and-fro murmur at the left lower sternal border.Echocardiography revealed left ventricle (lv) dilation, preserved lv ejection fraction, and progression to severe ar without an apparent cause.The patient subsequently underwent aortic valve replacement with a mechanical valve due to symptomatic severe ar.The patient experienced intermittent fever for one month at approximately three years after the operation, at which time echocardiography showed moderate paravalvular ar and partial dis-adhesion of the mechanical aortic valve with a fluttering mass.The patient subsequently received re-do aortic valve replacement with a bioprosthetic valve 21mm trifecta valve due to infective endocarditis.Pathologic results revealed suppurative inflammation.However, both blood and surgical specimen cultures returned negative results.A thickened aortic root was noted during operation, and subsequent ct, mri, and gallium scan results further supported the diagnosis of aortitis.During the index admission, the patient received high dose prednisolone for ta, which was gradually tapered over the following months while azathioprine was introduced.Recurrent episodes of intermittent fever in the subsequent years, indicative of ta flares, were effectively managed with intravenous tocilizumab.Three years after the second operation, the patient underwent pacemaker implantation due to complete atrioventricular block.The pacemaker was subsequently revised one year after the initial implantation due to endocarditis with vegetation on the atrial lead.Five years after the second operation, the patient developed worsening exertional dyspnea.A follow-up computed tomography angiography (cta) for ta indicated an aortic root pseudoaneurysm extending into the interventricular septum.The interventricular septal dissection had progressed incrementally over a 3-month period, approaching the insertion site of the pacemaker lead in the right ventricle, as revealed by both echocardiography the patient subsequently underwent surgery for interventricular septal dissection and pseudoaneurysms, moderate aortic bioprosthetic valve regurgitation/stenosis, and severe mitral regurgitation due to chamber dilation.Surgery consisted of trido-median sternotomy with the ascending aorta and direct bicaval cannulation.Inspection of the aortic root revealed a peri-annular pseudoaneurysms arising from the right coronary sinus of valsalva resulting in an interventricular septum dissection, a rocking aortic bioprosthetic valve (trifecta 21 mm) attaching to the intima of the dissected interventricular septum, and a previous peri-annular bovine pericardium patch over the sinus of valsalva.Also observed were a sclerotic change of the leaflet without vegetation or abscesses.During surgery, mitral annulus dilatation with intact leaflet was observed intraoperatively.Downsized mitral annuloplasty was performed with a 30 mm memo-3d ring using a superior18 extended trans-septal approach.The incised left atrium roof and the right atrium atriotomy were repaired with bovine pericardium.Three-month postoperative cta revealed a normal position of the prosthetic valve without pseudoaneurysms or fistulae.Echocardiography revealed a properly functioning aortic prosthetic valve.The patient had an uneventful, symptom-free daily living one year after the operation.In conclusion, interventricular septal dissection is a rare and potentially life-threatening condition, rendering timely diagnosis from clinical suspicion and image examinations critical.Interventricular septal dissection may be associated with inflammatory arteritis, but any suggestion of causation requires further investigation.[the primary and corresponding author was huang mu-shiang, division of cardiology, department of internal medicine, national cheng kung university hospital, college of medicine, national cheng kung university,138 sheng-li road, tainan 704, taiwan, tel: +886-6-2353535, ext.: 4331, e-mail: cortdog0817@gmail.Com].
Additional Manufacturer Narrative
D4 - the udi number is not known as the part and lot numbers were not provided.Literature: article title "aortic dissection extending into the interventricular septum following re-do aortic valve replacement surgery in a patient with takayasu¿s arteritis: a rare case report".As reported in a research article, aortic dissection extending into the interventricular septum following re-do aortic valve replacement surgery in a patient with takayasu¿s arteritis: a rare case report.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.

• 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: 20352630
• Report Number: 2135147-2024-04842
• Device Sequence Number: 7926653
• Product Code: LWR
• UDI-Device Identifier: 05414734052023
• UDI-Public: 05414734052023
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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,Followup
• Report Date (Section B): 10/16/2024

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-21A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/10/2024
• Supplement Date Received by Manufacturer: 10/10/2024
• Initial Report FDA Received Date: 10/02/2024
• Supplement Report FDA Received Date: 10/16/2024
• 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; Hospitalization
• Patient Age: 39 YR
• Patient Sex: Female