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

Catalog Number	EMAX-21
Medical Device Problem Codes	Material Deformation (2976); Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Mitral Valve Insufficiency/ Regurgitation (4451); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2024
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 13 june 2024, a 21mm epic max valve was chosen for a procedure.During procedure, the valve was implanted and when the pump was off a leak was noted, they mentioned something wrong with the leaflets.The physician went back on pump and the valve was removed and a new 21mm epic max valve was implanted.The patient remained hemodynamically stable throughout the procedure.There was a delay in the procedure but not hemodynamically compromised.The patient was reported stable and discharged.
Event or Problem Description
It was reported that on 13 june 2024, a 21mm epic max valve was chosen for a procedure.During procedure, the valve was implanted and when the pump was off a leak was noted, they mentioned something wrong with the leaflets.The physician went back on pump and the valve was removed and a new 21mm epic max valve was implanted.The patient remained hemodynamically stable throughout the procedure.There was a delay in the procedure but not hemodynamically compromised.The patient was reported stable and discharged.
Additional Manufacturer Narrative
An event of central regurgitation and material deformation during implant was reported.Device returned to abbott and found the sewing cuff was intact and contained blood/body fluids.One of the leaflet noted to have an hole on it.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications, including functional testing prior to release form abbott.This test ensures proper cuspal coaptation and hemodynamic performance.Other possible causes of regurgitation post implant include non-structural valve dysfunction.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.It is very unlikely this kind of damage in the leaflet not would not be noticed by the inspectors.Besides the visual inspection, this product would not be approved on the steady flow tester presenting this hole in the leaflet.Based on the information associated with this complaint, it seems to me this damaged could be caused by a sharp instrument.This instrument could cause a tear and consequently the hole in this leaflet.Therefore, it is unlikely to have the product leaving the manufacturing facility in this condition.H6 health effect - clinical code: code 4582 removed.

• Brand Name: EPIC MAX 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: 19698354
• Report Number: 2135147-2024-03292
• Device Sequence Number: 7674075
• Product Code: LWR
• UDI-Device Identifier: 05415067045447
• UDI-Public: (01)05415067045447(17)270816(10)BR00040206
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2024

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 Catalogue Number: EMAX-21
• Device Lot Number: BR00040206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/13/2024
• Supplement Date Received by Manufacturer: 07/19/2024
• Initial Report FDA Received Date: 07/09/2024
• Supplement Report FDA Received Date: 08/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2023
• 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 Sex: Unknown