MAUDE Adverse Event Report: ABBOTT MEDICAL EPIC¿ VALVE (MITRAL); HEART-VALVE, NON-ALLOGRAFT TISSUE

Catalog Number E100-29M

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation (2001)

Event Date 01/30/2024

Event Type  Injury  

Manufacturer Narrative

Summarized patient outcomes/complications of epic valve were reported in a research article in a subject population with moderate mitral regurgitation.One of the complications reported was perforation.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.

Event Description

The article, "ventricular septal defect following mitral valve replacement", was reviewed.The article presented a case study of a 73-year-old female patient with long-standing moderate mitral regurgitation.It was reported that on an unknown date, a 29mm epic valve was chosen for mitral valve replacement procedure following a failed mitral valve repair with a 32mm edwards physio ii annuloplasty ring.Intraoperative transesophageal echocardiography (tee) showed a well-functioning valve without any complications and was discharged uneventfully.It was noted a pre-discharge limited transthoracic echocardiography (tte) was unremarkable with no ventricular septa defect (vsd) noted.During a routine post-procedure follow up, the patient was noted to have a loud holosystolic murmur but was asymptomatic.A tte showed a new restrictive basal vsd with a left-to-right shunt along with a well-functioning mitral prosthesis and normal cardiac function.Cardiac magnetic resonance (cmr) imaging confirmed the s basal inferoseptal vsd that was hemodynamically insignificant.There was no infarction or fibrosis near the vsd.A cardiac computed tomography (ct) scan showed a very long membranous septum (ms) with a small vsd.Non-surgical conservative management was recommended given the small size of the vsd and the symptomatic status.The article concluded that this case highlights that small vsds may be missed on tee/tte if not specifically looked for.In this case, the vsd was located inferiorly in the membranous septum, and this area is often not well seen on tte.Sonographers should specifically interrogate the ventricular septum, along with inferior angulation from the apical 4-chamber view, in all patients after mitral valve surgery (mvs).[the primary author was jose arriola-montenegro, department of medicine, university of minnesota medical school, minneapolis, minnesota, usa.The corresponding author was prabhjot s.Nijjar, cardiovascular division, department of medicine, university of minnesota medical school, minneapolis, minnesota, usa, with corresponding email: nijja003@umn.Edu].

• Brand Name: EPIC¿ VALVE (MITRAL)
• 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: 18743264
• MDR Text Key: 335811836
• Report Number: 2135147-2024-00758
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: E100-29M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other
• Patient Age: 73 YR
• Patient Sex: Female