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

Catalog Number ESP100-19

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993); Central Regurgitation (4068)

Patient Problems Endocarditis (1834); Fatigue (1849); Fever (1858); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 03/08/2023

Event Type  Injury  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that on 14 december 2022 a 19mm epic supra valve was implanted in the patient's aortic valve and a 27mm epic valve was implanted in the patient's mitral valve.It was reported on (b)(6) 2023, the patient experienced a fever and malaise due to prosthetic valve endocarditis (pve) on the 27mm epic valve.It was reported the physician attributed the pve occurred to the patient herself.On (b)(6) 2023, a decision was made to perform a double valve replacement procedure and explant the 19mm epic supra valve and the 27mm epic valve.It was then reported an 18mm non-abbott aortic valve was implanted in the patient's aortic valve and a 25mm sjm masters series heart valve w/ teflon cuff was implanted in the patient's mitral valve.The patient status was reported as stable.

Event Description

It was reported that on (b)(6) 2022 a 19mm epic supra valve was implanted in the patient's aortic valve and a 27mm epic valve was implanted in the patient's mitral valve.It was reported on (b)(6)2023, the patient experienced a fever and malaise due to prosthetic valve endocarditis (pve) on the 27mm epic valve.It was reported the physician attributed the pve to patient condition.On(b)(6) 2023, a decision was made to perform a double valve replacement procedure and explant the 19mm epic supra valve and the 27mm epic valve.It was then reported an 18mm non-abbott aortic valve was implanted in the patient's aortic valve and a 25mm sjm masters series heart valve w/ teflon cuff was implanted in the patient's mitral valve.The patient status was reported as stable.

Manufacturer Narrative

An event of endocarditis three months after a double valve replacement was completed and due to the endocarditis and regurgitation on both valves; both valves were explanted was reported.The investigation found that cusp 1 was torn.There was inflow thrombus on cusp 1 which had a microcalcification within it.No inflammation was present.Gram and silver stains were negative for organisms.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Information from the field indicated that the endocarditis was due to the patient.The tear and thrombus noted on the valve could have contributed to the reported regurgitation.There is no indication of a product quality issue with regards to manufacture, design, or labeling.H6 medical device problem code: code 2993 removed.

• Brand Name: EPIC¿ SUPRA VALVE (AORTIC)
• Type of Device: 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: 16704783
• MDR Text Key: 312934516
• Report Number: 2135147-2023-01541
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P040021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ESP100-19
• Device Lot Number: 8561916
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 88 YR
• Patient Sex: Female
• Patient Weight: 44 KG