MAUDE Adverse Event Report: ABBOTT MEDICAL EPIC PLUS; HEART-VALVE, NON-ALLOGRAFT TISSUE

Catalog Number	E200-29M
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	03/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on 16 feb.2024, a 29mm epic plus mitral valve was implanted in a patient.On (b)(6) 2024, the patient was diagnosed with thrombosis of the mitral valve and it was necessary to use an anticoagulant to treat the problem.Transesophageal echocardiogram in addition to the transthoracic examination carried out on (b)(6) 2024 showed anomalous movement of the interventricular septum.Preserved myocardial contractility of the other segments of the left ventricle.Preserved biventricular systolic function.Biological prosthesis in mitral position with thin leaflets, preserved opening (av = 2.1 cm²).Doppler does not show reflux.Maximum dg of 15 mmhg, average dg of 5mmhg.A heterogeneous image is observed, with anechoic points inside it and small mobile components adhered to its surface adjacent to the medial prosthetic ring, extending from the left atrial wall to the lower portion of the interatrial septum, measuring 14x5mm.Another slightly heterogeneous image can be seen on the lateral portion of the prosthetic ring, measuring 3.6x8mm.Such findings may correspond to abscess formation.The patient is stable.
Additional Manufacturer Narrative
An event of patient device interaction problem (thrombus) was reported.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.Information from the field indicated that a epic plus mitral valve was implanted in a patient.Later on, the patient was diagnosed with thrombosis of the mitral valve and an anticoagulant medication was used to treat the problem.The patient is stable.Based on the information received, a 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.

• Brand Name: EPIC PLUS
• Common Device Name: 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: 19221087
• Report Number: 2135147-2024-01914
• Device Sequence Number: 7166124
• Product Code: LWR
• UDI-Device Identifier: 05415067033086
• UDI-Public: 05415067033086
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P040021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: E200-29M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/10/2024
• Supplement Date Received by Manufacturer: 06/07/2024
• Initial Report FDA Received Date: 05/01/2024
• Supplement Report FDA Received Date: 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 33 YR
• Patient Sex: Unknown