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

Catalog Number	ESP200-21
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Heart Failure/Congestive Heart Failure (4446)
Date of Event	08/08/2023
Type of Reportable Event	Death
Event or Problem Description
It was reported that on an unknown day in (b)(6) 2022, a 21mm epic tissue heart valve was implanted in a patient.After a year on an unknown date, the patient had thrombosis of the valve that caused its deterioration which was seen on coronary angiotac and echocardiogram.The patient did not have any hematologic disorders or systemic illness that could contribute to a hypercoagulability.On (b)(6) 2023 an explant procedure of the device was carried out and a 21mm epic plus supra was implanted as a replacement.It was reported that the patient passed away due to ventricular dysfunction post explant.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of thrombosis of the valve causing deterioration and patient death was reported.It was reported that the valve was explanted and the patient expired due to ventricular dysfunction post explant.The patient had medical history of aortic stenosis.A returned device assessment and histopathological examination could not be performed as the device remains implanted and was not returned for analysis.Information from field indicated that the patient did not have any hematologic disorders or systemic illness that could contribute to a hypercoagulability.Field also indicated that the patient did not receive any treatment/medication that could contribute to thrombus formation.Biological factors such as calcification (from patient conditions predisposing to elevated calcium like renal disease), immobilizing thrombus, or pannus formation reducing the valve diameter which could contribute to device stenosis could not be confirmed as the valve was not returned for histopathological examination.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: EPIC¿ SUPRA VALVE (AORTIC)
• 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: 17703892
• Report Number: 2135147-2023-03899
• Device Sequence Number: 15303589
• Product Code: LWR
• UDI-Device Identifier: 05415067033123
• UDI-Public: 05415067033123
• Combination Product (Y/N): N
• Initial Reporter Country: EC
• PMA/510(K) Number: P040021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2023

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 Catalogue Number: ESP200-21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/14/2023
• Supplement Date Received by Manufacturer: 10/06/2023
• Initial Report FDA Received Date: 09/07/2023
• Supplement Report FDA Received Date: 10/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Age: 75 YR
• Patient Sex: Male