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

Model Number	E200-33M
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Endocarditis (1834); Mitral Valve Insufficiency/ Regurgitation (4451)
Date of Event	11/08/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on an unknown date, a 33mm epic plus valve was successfully implanted in a patient.On (b)(6) 2022, it was noted that the patient was suffering from device related endocarditis.It was also noted that the patient had mitral regurgitation.The decision was made to explant and replace the 33mm epic plus valve is an unknown size non-abbott device.The patient status was reported as unknown.
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 an unknown date, a 33mm epic valve was successfully implanted in a patient.On (b)(6) 2022, it was noted that the patient was suffering from device related endocarditis.It was also noted that the patient had mitral regurgitation.The decision was made to explant and replace the 33mm epic valve with an unknown size non-abbott device.The patient status was reported as unknown.
Additional Manufacturer Narrative
An event of regurgitation secondary to endocarditis was reported.The valve was received for investigation which found that cusps 1 and 2 were torn and contained calcifications.No inflammation was noted.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The cause of the tears could not be conclusively determined; however, one of the tears was associated with calcifications.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• 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 PUERTO RICO, INC. REG#2648612; 20 b st caguas west park; caguas 00725 ; * 00725
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16038099
• Report Number: 2135147-2022-02694
• Device Sequence Number: 12128321
• Product Code: LWR
• UDI-Device Identifier: 05414734055611
• UDI-Public: 05414734055611
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P040021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• 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): 04/18/2023

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: 10/19/2014
• Device Model Number: E200-33M
• Device Catalogue Number: E100-33M-00
• Device Lot Number: 3293641
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/01/2022
• Supplement Date Received by Manufacturer: 04/05/2023
• Initial Report FDA Received Date: 12/22/2022
• Supplement Report FDA Received Date: 04/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2010
• 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: 64 YR
• Patient Sex: Male