MAUDE Adverse Event Report: ABBOTT MEDICAL EPIC SUPRA VALVE W/FLEXFIT; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number	ESP200-23
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dyspnea (1816); Endocarditis (1834); Heart Failure/Congestive Heart Failure (4446)
Date of Event	01/20/2023
Type of Reportable Event	Death
Event or Problem Description
It was reported that on (b)(6) 2022, a 23mm epic plus valve was successfully implanted.On (b)(6) 2023, the patient reported to the hospital with shortness of breath and a new york heart association (nyha) functional classification of iv.The patient was admitted to the hospital with an infection and vegetation.The patient was diagnosed with endocarditis.Intravenous antibiotics were administered, followed by surgical replacement.On an unknown date, the patient died.No additional information was able to be provided by the hospital.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.Date of death is estimated to (b)(6) 2023 as the date of death was not provided.
Additional Manufacturer Narrative
An event of shortness of breath, infection, vegetation, endocarditis and patient death was reported.A more comprehensive assessment, including histopathological examination of the valve tissue could not be performed as the device remained implanted and was not returned for analysis.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.

• Brand Name: EPIC SUPRA VALVE W/FLEXFIT
• 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: 16395704
• Report Number: 2135147-2023-00566
• Device Sequence Number: 5543603
• Product Code: LWR
• UDI-Device Identifier: 05415067033130
• UDI-Public: 05415067033130
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P040021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 04/07/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/13/2026
• Device Model Number: ESP200-23
• Device Catalogue Number: ESP200-23
• Device Lot Number: BR00033438
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/20/2023
• Supplement Date Received by Manufacturer: 03/31/2023
• Initial Report FDA Received Date: 02/17/2023
• Supplement Report FDA Received Date: 04/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2022
• 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: Death
• Patient Sex: Unknown