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

Catalog Number E100-29M

Device Problem Material Split, Cut or Torn (4008)

Patient Problems Heart Failure/Congestive Heart Failure (4446); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 02/28/2024

Event Type  Death  

Manufacturer Narrative

The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that on (b)(6) 2024, an epic valve mitral was chosen for implantation during a triple valve replacement surgery.The patient presented with acute decompensation on massive aortic insufficiency, mitral insufficiency, tricuspid insufficiency with a weak right ventricle.The surgery was performed urgently due to the patient condition.The epic was placed in the mitral valve, a non-abbott valve was placed on the aortic valve, and a non-abbott ring was placed on the tricuspid valve.After weening the patient off of cardiopulmonary bypass (cpb), during an echocardiographic control imaging, a massive eccentric jet was observed coming through the epic valve.The patient was put back on cpb and the valve was explanted and replaced with a non-abbott 29mm valve.Outside of the patient, a tear was observed in the leaflet 1mm down the commissure along with fenestration of the leaflet.Bypass time was extended by 90 minutes.The patient left the operating room relatively stable.Temporary pacemaker wires were inserted in case the patient developed arrhythmia.Arrhythmia did not occur so the pacemaker was removed.Due to right ventricular failure along with fragility of patient, the patient died one day after the procedure on 29 february 2024.The physician attributes the death to the performance of the epic valve along with the procedural and patient conditions.

Manufacturer Narrative

An event of explant of epic mitral valve due to massive eccentric mitral regurgitation was reported.Also reported that explanted valve was observed to have a tear in the leaflet at commissure along with fenestration of the leaflet.The surgery was performed urgently due to the patient condition including massive aortic insufficiency, mitral insufficiency and tricuspid insufficiency with a weak right ventricle.Information from filed indicated that the bypass time was extended by 90 minutes.The patient left the operating room relatively stable.Due to right ventricular failure along with fragility of patient, the patient expired one day after the procedure.The investigation found that cusp 1 was torn.No inflammation or significant calcifications were present.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The cause of the reported incident could not be conclusively determined.

• 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: 19008405
• MDR Text Key: 338978269
• Report Number: 2135147-2024-01398
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P040021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/29/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: E100-29M
• Device Lot Number: 10147753
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/05/2024
• Initial Date FDA Received: 03/29/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/29/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/13/2023
• 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: 72 YR
• Patient Sex: Male
• Patient Weight: 66 KG