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

Catalog Number	ESP200-21
Medical Device Problem Code	Perivalvular Leak (1457)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/26/2023
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 05 september 2023, a 21mm epic plus supra was implanted in a patient.On (b)(6) 2023, the device was explanted due to a paravalar leak of 8 mmhg and average gradient of 35 mmhg.A 19mm sjm masters series hemodynamic plus valve was implanted as a replacement.Post implant, it was reported that the patient passed away.The cause and date of the death is unknown.
Event or Problem Description
It was reported that on (b)(6) 2023, a 21mm epic plus supra was implanted in a patient.On (b)(6) 2023, the device was explanted due to a paravalvular leak of 8 mmhg and average gradient of 35 mmhg.A 19mm sjm masters series hemodynamic plus valve was implanted as a replacement.Post implant, it was reported that the patient passed away.The cause and date of the death is unknown.
Additional Manufacturer Narrative
An event of device explant due to paravalvular 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.The device history record was also 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.Related manufacturer reference number: 2135147-2023-04703-00.
Additional Manufacturer Narrative
An event of device explant due to paravalvular leak was reported.The device was received for investigation and no anomalies were found.The device passed functional testing both at the time of manufacturing and upon return to abbott.The device history record was also reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.In the absence of any evidence of valve anomaly that may impact valvular function, the reported event is consistent with a non-structural valve dysfunction.A non-structural valve dysfunction (nsvd) is a known potential complication of valve replacement surgery as outlined in the instructions for use.Nsvd is commonly attributed to implant-related technical factors such as inappropriate sizing or positioning, entrapment by suture, stent deformation, or mishandling of the leaflet tissue.In this case inappropriate sizing, entrapment by suture, or stent deformation could not be confirmed due to the limited information provided.Temporary distortion of the stent due to external forces following aortic closure where the stent is not permanently deformed may also potentially explain the observed intraoperative valvular dysfunction.However, since it is not possible to determine whether there was any temporary intra-operative stent deformation and none of the other potential causes for nsvd could be confirmed except for a pvl, the exact cause of the observed valvular regurgitation cannot be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• 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: 18014074
• Report Number: 2135147-2023-04704
• Device Sequence Number: 7277174
• Product Code: LWR
• UDI-Device Identifier: 05415067033123
• UDI-Public: 05415067033123
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: P040021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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,Followup
• Report Date (Section B): 01/31/2024

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: 06/01/2026
• Device Catalogue Number: ESP200-21
• Device Lot Number: BR00033089
• 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: 10/04/2023
• Supplement Date Received by Manufacturer: 11/30/2023; 01/30/2024
• Initial Report FDA Received Date: 10/26/2023
• Supplement Report FDA Received Date: 12/19/2023; 01/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2022
• 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: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female