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

Catalog Number E100-25M

Device Problems Patient-Device Incompatibility (2682); Material Split, Cut or Torn (4008); Device Stenosis (4066); Central Regurgitation (4068)

Patient Problems Dyspnea (1816); Mitral Valve Stenosis (1965); Heart Failure/Congestive Heart Failure (4446); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 11/21/2023

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 on (b)(6) 2015, a 25mm epic valve was implanted in the patient.On (b)(6) 2023, a periodic follow up check up was conducted and symptoms of heart failure were confirmed by echocardiography.The annular dimensions of the native valve was 25mm.On (b)(6) 2023, a follow up was conducted and patient underwent a semi-urgent operation due to intensified heart failure and dysfunction of valve.The patient had sit-up breathing, severe mitral regurgitation (mr), mean pressure gradient 8hg, doppler velocity index (dvi) was 2.9 the epic valve was explanted and a new 25mm epic valve was implanted as a replacement.Removed epic valve showed pannus formation and tear of the leaflet.The patient's condition was reported stable.

Manufacturer Narrative

Explant due to symptoms of heart failure and severe mitral regurgitation was reported.Also reported that explanted valve showed pannus formation and tear in the cusp.The investigation found that cusps 1 and 3 were torn.The outflow surfaces of cusps 1 and 2 had fibrous pannus limited to the sewing cuff.There was thinning and loss of collagen on all three cusps.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.In the absence of any calcification at the tear site or evidence for infection, the reported event is consistent with a non-calcific leaflet tear.A non-calcific leaflet tear is a form of structural valve deterioration (svd), which is a well-known complication from valve replacement surgery.A non-calcific leaflet tear is commonly attributed to increased operational leaflet stress but may also be related to biological factors which result in tissue degeneration characterized by loss of collagen.In this case, histological evaluation did demonstrate loss of collagen at the tear site.The cause of the leaflet tear 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 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: 18360163
• MDR Text Key: 330931592
• Report Number: 2135147-2023-05591
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/30/2018
• Device Catalogue Number: E100-25M
• Device Lot Number: 4751902
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2014
• 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; Hospitalization
• Patient Age: 83 YR
• Patient Sex: Female