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

Catalog Number	E100-29M-00
Medical Device Problem Codes	Calcified (1077); Material Deformation (2976); Device Stenosis (4066)
Health Effect - Clinical Codes	Dyspnea (1816); Mitral Valve Stenosis (1965)
Date of Event	06/11/2024
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 (b)(6) 2021, a 29mm epic valve was implanted in the patient.After the procedure, the patient presented with shortness of breath and echocardiogram showed a gradient of 10mm.The valve was calcified with some leaflet deformity.The valve was explanted and a new non- abbott valve was implanted.The patient was reported stable.
Additional Manufacturer Narrative
An event of valve calcification, leaflet deformity, mitral valve stenosis, and dyspnea was reported.The device was returned to abbott for investigation, and all cusps were noted to have previously been dissected or torn.The outflow surface of one cusp was observed to have a layer of fibrin thrombus which was tethered to the fold of the free edge of the cusp.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met specifications.Based on the available information, the cause of the reported stenosis could not be conclusively determined.However, the thrombus formation and fibrotic thickening noted had the potential to induce increased stress on adjacent leaflets and create an unbalanced stress relief distribution between all leaflets during coaptation.The observed leaflet fold appears to be related to the fibrin thrombus formation tethered to the leaflet.The reported surgical intervention was a result of case-specific circumstances, as the device was explanted, and another valve was implanted.There is no indication of a product quality issue with regards to manufacture design or labeling.
Event or Problem Description
N/a.

• Brand Name: EPIC¿ VALVE (MITRAL)
• 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 #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: 19651834
• Report Number: 2135147-2024-03184
• Device Sequence Number: 6745461
• Product Code: LWR
• UDI-Device Identifier: 05414734055598
• UDI-Public: (01)05414734055598(17)241021(10)BR00026763
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P040021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2024

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: 10/21/2024
• Device Catalogue Number: E100-29M-00
• Device Lot Number: BR00026763
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/11/2024
• Supplement Date Received by Manufacturer: 11/18/2024
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 11/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2020
• 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 Sex: Female