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

Catalog Number	E100-27M-00
Medical Device Problem Code	Perivalvular Leak (1457)
Health Effect - Clinical Codes	Anemia (1706); Hemolysis (1886)
Date of Event	05/21/2024
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) 2020, a 27mm epic valve was successfully implanted in a patient.On (b)(6) 2023, it was noted that the patient's lab results were consistent with moderate hemolysis.On (b)(6) 2023, a transesophageal echocardiogram was performed and revealed a perivalvular leak (pvl) of the 27mm epic valve.On (b)(6) 2023, the decision was made to implant a 12x3mm amplatzer valvular plug 3 for closure of the pvl.The patient reports intermittent fatigue and dyspnea on exertion at the time of report.The patient is pending a follow up with cardiothoracic surgery to discuss/schedule further intervention.The cause of the pvl is attributed to mitral annular calcification.
Event or Problem Description
It was reported that on (b)(6) 2020, a 27mm epic valve was successfully implanted in a patient.On (b)(6) 2023, it was noted that the patient's lab results were consistent with moderate hemolysis.On (b)(6) 2023, a transesophageal echocardiogram was performed and revealed a perivalvular leak (pvl) of the 27mm epic valve.On (b)(6) 2023, the decision was made to implant a 12x3mm amplatzer valvular plug 3 for closure of the pvl.The patient reports intermittent fatigue and dyspnea on exertion at the time of report.The patient is pending a follow up with cardiothoracic surgery to discuss/schedule further intervention.The cause of the pvl is attributed to mitral annular calcification.
Additional Manufacturer Narrative
An event of perivalvular leak 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.No implant-related factors could be confirmed as information related to the implant procedure was not provided from the account.Information from the field indicated that the physician believed that the cause of the reported leak was due to the breakdown of annular tissue.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with respect to labeling, design, or manufacturing of the device.

• 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: 19656268
• Report Number: 2135147-2024-03205
• Device Sequence Number: 12399474
• Product Code: LWR
• UDI-Device Identifier: 05414734055574
• UDI-Public: (01)05414734055574(17)231110(10)BR00022976
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P040021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2024

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: 11/10/2023
• Device Catalogue Number: E100-27M-00
• Device Lot Number: BR00022976
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/07/2024
• Supplement Date Received by Manufacturer: 08/12/2024
• Initial Report FDA Received Date: 07/02/2024
• Supplement Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/11/2019
• 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: Unknown