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

Model Number E100-29M

Device Problems Calcified (1077); Off-Label Use (1494); Central Regurgitation (4068)

Patient Problems Dyspnea (1816); Tricuspid Valve Insufficiency/ Regurgitation (4453)

Event Date 09/08/2023

Event Type  Injury  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that 3 years ago on an unknown date, a 29mm stented porcine,mit,epic was implanted in a patient.The patient reported to have dyspean six month prior to the explant procedure.The patient had vena cava filter due to a venous thrombosis and the device migrated to the heart.When the physician tried to recover it, it got stuck in the native tricuspid valve and ruptured causing sudden severe insufficiency and shock in the patient.An emergency surgery was done on 08 september 2023.The valve was explanted due to calcium noted on the valve, and severe valve regurgitation.A 25mm sjm masters series mechanical heart valve device was implanted as a replacement.The reason why a biological valve was implanted at the time was because the patient did not want to be anticoagulated due to sports issues.The patient remain stable.

Manufacturer Narrative

Explant of the device after 3 years due to insufficiency, regurgitation, and fixed leaflets was reported.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.A more comprehensive assessment, including histopathological examination of the valve tissue could not be performed as the device was not returned for analysis.Information from the field indicated that the valve was implanted in the tricuspid position.It was also reported that the valve was calcified, which could have contributed to the reported event.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

Manufacturer Narrative

A valve initially implanted to address thrombosis was explanted due to dyspnea, calcification and severe regurgitation was reported.A more comprehensive assessment, including histopathological examination of the valve tissue could not be performed as the device was not returned for analysis.The provided images illustrate pannus present on the valve outflow surface, potentially causing difficulty of leaflet opening, along with torn leaflets.The cause of torn leaflets remains uncertain, whether they occurred during process of implant or explant of the valve.Calcification and regurgitation were noted, which could have contribute to leaflet tears formation.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 reported incident could not be conclusively determined, but classification of the valve may have contributed to the reported event.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

Event Description

It was reported that in approximately 2020, a 29mm epic mitral valve chosen for implant.The patient had an unrelated procedure for a vena cava filter due to a venous thrombosis, and the device migrated to the heart.When the physician tried to recover the filter, it got stuck in the native tricuspid valve and ruptured, causing sudden severe insufficiency and shock in the patient.The 29mm epic mitral valve was implanted in an emergency surgery in approximately 2020.It was later reported that the patient began having dyspnea in approximately (b)(6) 2023.On (b)(6) 2023, the valve was explanted due to calcification and severe valve regurgitation.A 25mm sjm masters series mechanical heart valve was implanted as a replacement device.The patient remain stable.

• 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 LTDA. REG#3001883144; 1301rua profvieira demendonça; bairro engenho nogueira 31.31 0-26; BR 31.310-260
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17878735
• MDR Text Key: 325015420
• Report Number: 2135147-2023-04343
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: MX
• 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,Followup
• Report Date: 03/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/03/2023
• Device Model Number: E100-29M
• Device Catalogue Number: E100-29M
• Device Lot Number: BR00020710
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2019
• 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
• Patient Age: 26 YR
• Patient Sex: Male