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

Catalog Number TF-23A

Device Problem Device Stenosis (4066)

Patient Problems Aortic Valve Stenosis (1717); Heart Failure/Congestive Heart Failure (4446)

Event Date 01/04/2023

Event Type  Injury  

Manufacturer Narrative

Attachment: article titled "thoracic aorta perforation treated conservatively after tavr in a patient with extremely tortuous aorta".Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

The article, "thoracic aorta perforation treated conservatively after tavr in a patient with extremely tortuous aorta", was reviewed.The article presented a case study of an 82-year-old morbidly obese female patient with hypertrophic obstructive cardiomyopathy, restrictive and obstructive lung disease with intermittent use of oxygen.It was reported that on an unknown date, a 23mm trifecta valve was implanted.It was then reported 8 years post-procedure, the patient presented with worsening heart failure symptoms.A transthoracic echocardiography (tte) revealed severe biological valve degeneration with a mean gradient of 45mmhg.A decision was made to perform a transcatheter valve-in-valve procedure with a 23mm balloon expandable sapien 3.[the primary and corresponding author was lisa manevich, department of cardiology, e.Wolfson medical center, holon and tel-aviv university, tel-aviv 5822012, israel, with corresponding e-mail: (b)(6)].No peri-procedural complications were reported.Post-procedural complications included surgical intervention, hospitalization, heart failure, aortic stenosis.

Manufacturer Narrative

Summarized patient outcomes/complications of trifecta valve were reported in a research article in a subject population with multiple co-morbidities including hypertrophic obstructive cardiomyopathy, morbidly obese, restrictive and obstructive lung disease with intermittent use of oxygen.Some of the complications reported were surgical intervention, hospitalization, heart failure, and aortic stenosis.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device or individual patient information was received for analysis.Literature attachment: article title: thoracic aorta perforation treated conservatively after tavr in a patient with extremely tortuous aorta.

• Brand Name: SJM TRIFECTA VALVE
• Type of Device: 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: 18915207
• MDR Text Key: 337797107
• Report Number: 2135147-2024-01145
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: P100029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: TF-23A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 82 YR
• Patient Sex: Female