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

Catalog Number E100-29M

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Endocarditis (1834); Fatigue (1849); Fever (1858); Hypoxia (1918); Pulmonary Edema (2020); Renal Failure (2041); Pseudoaneurysm (2605); Vascular Dissection (3160); Heart Block (4444); Respiratory Insufficiency (4462)

Event Date 02/15/2023

Event Type  Death  

Manufacturer Narrative

Literature article: "left atrial dissection after a supra annular mitral valve replacement for endocarditis".Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

The article, "left atrial dissection after a supra annular mitral valve replacement for endocarditis", was reviewed.The article presented a case study of a 66-year-old female patient with acute heart failure due to severe aortic and mitral valve stenosis.It was reported that on 07 october 2021, the patient underwent concomitant mitral and aortic valve replacement with a 29mm epic mitral valve and a 21mm trifecta gt aortic valve.The patient was discharged after a 10-day hospitalization.It was then reported 4 weeks post-procedure, the patient was admitted to the hospital for asthenia and fever.An electrocardiogram (ecg) diagnosed atrioventricular block and blood cultures were positive for enterococcus faecalis.Transthoracic echocardiography (tte) confirmed the presence of a double supracentimetric endocarditis on the two prosthetic valves with an aortic root abscess.The patient received antibiotic therapy with ceftriaxone and amoxicillin.A decision was made to perform surgical replacement of the epic and trifecta valves.On 07 november 2021, the 29mm epic valve was replaced with a 31mm edwards magna ease valve, the 21mm trifecta gt valve was replaced with a 21mm edwards magna ease valve, and the patient received a leadless pacemaker implant.Due to extensive deterioration of the mitral annulus, it was reported the 31mm edwards magna ease valve was implanted supra-annularly.On an unknown date post-operatively, the patient experienced acute kidney injury that required continuous renal replacement therapy.It was reported on an unknown unknown date one week post-intervention procedure, the patient developed severe hypoxemic respiratory failure due to pulmonary edema requiring mechanical ventilation.Transoesophageal echocardiography (toe) revealed a left atrial (la) wall dissection and creation of a new atrium cavity interpreted as a false aneurysm behind the la posterior wall and squeezing the left atrium at every systole.Contrast-enhanced synchronized cardiac computed tomography (ct) scan confirmed the false aneurysm measured 65 x 40 x 30 mm behind the la with a mass effect on it, communicating with the left ventricle outflow tract through a 23-mm defect close to the mitral valve prosthesis.Weaning from mechanical ventilation was unsuccessful.The patient was considered high risk of a third surgery and a palliative care support was collegially decided.It was reported the patient passed away on an unknown date.The article concluded that left atrial dissection can occur after a redo surgery and supra-annular mitral valve implantation.Multimodal imagery including transoesophageal echocardiography and cardiac ct-scan is helpful for the diagnosis.[the primary and corresponding author was guillaume thery, intensive care medicine, reims university hospital, reims, france, with corresponding email: guillaume.D.Thery@gmail.Com].

Event Description

The article, "left atrial dissection after a supra annular mitral valve replacement for endocarditis", was reviewed.The article presented a case study of a 66-year-old female patient with acute heart failure due to severe aortic and mitral valve stenosis.It was reported that on (b)(6) 2021, the patient underwent concomitant mitral and aortic valve replacement with a 29mm epic mitral valve and a 21mm trifecta gt aortic valve.The patient was discharged after a 10-day hospitalization.It was then reported 4 weeks post-procedure, the patient was admitted to the hospital for asthenia and fever.An electrocardiogram (ecg) diagnosed atrioventricular block and blood cultures were positive for enterococcus faecalis.Transthoracic echocardiography (tte) confirmed the presence of a double supracentimetric endocarditis on the two prosthetic valves with an aortic root abscess.The patient received antibiotic therapy with ceftriaxone and amoxicillin.A decision was made to perform surgical replacement of the epic and trifecta valves.On (b)(6) 2021, the 29mm epic valve was replaced with a 31mm edwards magna ease valve, the 21mm trifecta gt valve was replaced with a 21mm edwards magna ease valve, and the patient received a leadless pacemaker implant.Due to extensive deterioration of the mitral annulus, it was reported the 31mm edwards magna ease valve was implanted supra-annularly.On an unknown date post-operatively, the patient experienced acute kidney injury that required continuous renal replacement therapy.It was reported on an unknown unknown date one week post-intervention procedure, the patient developed severe hypoxemic respiratory failure due to pulmonary edema requiring mechanical ventilation.Transoesophageal echocardiography (toe) revealed a left atrial (la) wall dissection and creation of a new atrium cavity interpreted as a false aneurysm behind the la posterior wall and squeezing the left atrium at every systole.Contrast-enhanced synchronized cardiac computed tomography (ct) scan confirmed the false aneurysm measured 65 x 40 x 30 mm behind the la with a mass effect on it, communicating with the left ventricle outflow tract through a 23-mm defect close to the mitral valve prosthesis.Weaning from mechanical ventilation was unsuccessful.The patient was considered high risk of a third surgery and a palliative care support was collegially decided.It was reported the patient passed away on an unknown date.The article concluded that left atrial dissection can occur after a redo surgery and supra-annular mitral valve implantation.Multimodal imagery including transoesophageal echocardiography and cardiac ct-scan is helpful for the diagnosis.[the primary and corresponding author was guillaume thery, intensive care medicine, reims university hospital, reims, france, with corresponding email: guillaume.D.Thery@gmail.Com].

Manufacturer Narrative

Literature article: "left atrial dissection after a supra annular mitral valve replacement for endocarditis".Summarized patient outcomes/complications of epic valve were reported in a research article in a subject population with multiple co-morbidities including acute heart failure due to severe aortic and mitral stenosis.Some of the complications reported were surgical intervention, unexpected medical intervention, hospitalization, endocarditis, fever, asthenia, atrioventricular block, renal injury, hypoxemia, pulmonary edema, dissection, pseudoaneurysm and patient death.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.

• 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: 18833169
• MDR Text Key: 336849310
• Report Number: 2135147-2024-00984
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P040021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• 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: 03/15/2024
• 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): Death
• Patient Age: 66 YR
• Patient Sex: Female