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

Catalog Number	E200-29M
Medical Device Problem Codes	Incomplete Coaptation (2507); Patient Device Interaction Problem (4001); Device Stenosis (4066)
Health Effect - Clinical Codes	Mitral Valve Stenosis (1965); Thrombosis/Thrombus (4440)
Date of Event	09/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2023, a 29mm epic plus mitral valve was implanted in the patient.Three months ago, a valve failure was diagnosed, patient had severe dysfunction, severe stenosis.On (b)(6) 2024, transesophageal echocardiogram showed patient had a thrombus in the mitral valve and the valve leaflets were dysfunctional.An explanation procedure will be performed on (b)(6) 2024 and the valve was replaced with a 29mm non-abbott valve.The pateit was reported stable and recovering from the surgery.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
Added patient code 4624 (surgical intervention, surgical removal of device).An event of thrombus, leaflet incomplete coaptation, mitral valve stenosis, and hospitalization was reported.Possible causes of stenosis include calcification (from patient conditions predisposing to elevated calcium like renal disease etc.), immobilizing thrombus, or pannus formation reducing valve diameter.The device was returned to abbott for investigation and the cusps were noted to have limited mobility when manually manipulated and the sewing cuff was observed to be torn.There was fibrous pannus ingrowth on the inflow surface extending 1 to 2 mm onto the base of cusp 3.Thrombus was observed in all of the outflow cusps.The device history record was also reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Based on the available information and device analysis, it appears the observed pannus ingrowth and thrombus formation on the cusps could have contributed to the stenosis.The cause of the thrombus could not be conclusively determined.However, the valve had pannus ingrowth on the inflow surface extending 1 to 2 mm onto the base of cusp 3, potentially interfering with blood flow and reducing the cusp opening area.If the cusp does not fully open, there is potential for stasis to occur on the outflow surface of the cusp and ultimately result in a thrombus formation.The reported hospitalization and surgical intervention were result of case-specific circumstances as the patient was admitted, the valve was explanted, and another valve was implanted.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
Event or Problem Description
N/a.

• 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: 20343861
• Report Number: 2135147-2024-04810
• Device Sequence Number: 7880047
• Product Code: LWR
• UDI-Device Identifier: 05415067033086
• UDI-Public: (01)05415067033086(17)261004(10)BR00035948
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: P040021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/04/2026
• Device Catalogue Number: E200-29M
• Device Lot Number: BR00035948
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/06/2024
• Supplement Date Received by Manufacturer: 11/11/2024
• Initial Report FDA Received Date: 10/01/2024
• Supplement Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/05/2022
• 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; Hospitalization
• Patient Sex: Unknown