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

Catalog Number UNK EPIC STENTED PORCINE HV

Device Problems Off-Label Use (1494); Incomplete Coaptation (2507); Patient Device Interaction Problem (4001)

Patient Problems Low Blood Pressure/ Hypotension (1914); Hypoxia (1918); Syncope/Fainting (4411); Thrombosis/Thrombus (4440); Unspecified Tissue Injury (4559)

Event Date 01/01/2023

Event Type  Injury  

Manufacturer Narrative

As reported in a research article, "case which thrombus adhered onto the prosthetic tissue heart valve on early postoperative for tricuspid valve replacement", on an unknown date, a 25mm epic valve was chosen for an off-label tricuspid valve replacement procedure in a female patient in their 70's with a previously implanted permanent pacemaker for sick sinus syndrome.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.There were no peri-procedural complications.Post-procedural complications included surgical intervention, unexpected medical intervention, hospitalization, hypotension, hypoxia, unspecified tissue injury, syncope, thrombus, off label use, incomplete leaflet coaptation.Based on the information received, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling please note per the instructions for use, 'the epic valve is indicated for patients requiring replacement of a diseased, damaged, or malfunctioning native aortic and/or mitral heart valve.It may also be used as a replacement for a previously implanted aortic and/or mitral prosthetic heart valve.

Event Description

The article, "case which thrombus adhered onto the prosthetic tissue heart valve on early postoperative for tricuspid valve replacement", was reviewed.The article presented a case study of a female patient in their 70's with a previously implanted permanent pacemaker for sick sinus syndrome.It was reported that on an unknown date, a 25mm epic valve was chosen for an off-label tricuspid valve replacement procedure.It was then reported the patient developed a reeling gait caused by atrioventricular conduction that was detected post-operatively.A decision was made to implant a leadless pacemaker on the 24th post-operative day.On an unknown date, it was reported the patient experienced low blood pressure and loss of consciousness.The patient's oxygenation status deteriorated.Echocardiography detected restricted tricuspid leaflets that were unable to open normally.The patient's maximum blood flow increased up to 2.1 m/s.Dilated right atrium was confirmed and a micro-bubble test revealed a right-left shunt flow that caused hypoxemia.It was reported the patient's international normalized ratio (pt-inr) hovered 1.6 to 2.0 and anticoagulation therapy was reinforced.However, there was no improvement to the leaflet function or the patient's oxygenation status.A right cardiac catheterization showed 5.4mmhg pressure gradient between right ventricle and right atrium.Echocardiography noted qp/qs was 0.45.A decision was made to surgically explant the 25mm epic valve and replaced with an unknown device on an unknown date two months post-implant procedure.The patient also underwent a concomitant patent ovale foramen closure.During the explant procedure, it was noted there was a thrombus attached in the tricuspid annulus at the side of the ventricle which was thought to be cause for the restricted leaflet movement.[the primary and corresponding author was (b)(6)].

• Brand Name: EPIC¿ VALVE (AORTIC)
• 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: 18801607
• MDR Text Key: 336508708
• Report Number: 2135147-2024-00921
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK EPIC STENTED PORCINE HV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2024
• 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): Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Female