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

Model Number	EMAX-19
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2026, a 19mm epic max valve was chosen for a minimally invasive aortic valve replacement (mics avr) procedure.During procedure, the valve was seated into the annulus and the operation was completed using a non-abbott suture device.However, during follow-up, bleeding was identified because the tip of the non-abbott suture device had penetrated the aortic wall, and therefore a reoperation was performed with a new 21mm epic max valve.A redo avr (with annular enlargement) was conducted, and the procedure was completed.The cause of bleeding remains unclear whether the adverse event resulted from oversizing of the epic max valve or from the orientation of the non-abbott device.The patient was reported stable.
Additional Manufacturer Narrative
The device is not returning for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of bleeding identified after 6-days of epic valve implant was reported.Also reported that a reoperation was performed with a new 21 mm epic max valve.To manage bleeding the aortic wall was reinforced using a bovine pericardial patch.A returned device assessment could not be performed as the device remains implanted and 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 reported bleeding appears consistent with non-abbott suture device penetrating aortic valve.However, this cannot be confirmed.The exact cause could not be conclusively determined.The surgical intervention was a result of reoperation performed to managing bleeding.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Codes removed: health effect- impact code: 4614.
Event or Problem Description
It was reported that on (b)(6) 2026, a 19mm epic max valve was chosen for a minimally invasive aortic valve replacement (mics avr) procedure.During procedure, the valve was seated into the annulus and the operation was completed using a non-abbott suture device.On(b)(6) 2026, during follow-up a bleeding was identified because the tip of the non-abbott suture device had penetrated the aortic wall, and therefore a reoperation was performed with a new 21mm epic max valve.To manage bleeding the aortic wall was reinforced using a bovine pericardial patch.The patient's activated clotting time (act) levels were 480s and the international normalized ratio (inr) was 2.0.A redo avr (with annular enlargement) was conducted, and the procedure was completed.The cause of bleeding remains unclear whether the adverse event resulted from oversizing of the epic max valve or from the orientation of the non-abbott device.The patient was reported stable.

• 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: 24349417
• Report Number: 2135147-2026-00946
• Device Sequence Number: 11999946
• Product Code: LWR
• UDI-Device Identifier: 05415067045461
• UDI-Public: (01)05415067045461(17)290714
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2026

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 Model Number: EMAX-19
• Device Catalogue Number: EMAX-19
• Device Lot Number: BR00053507
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2026
• Supplement Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 02/16/2026
• Supplement Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/15/2025
• 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: Other; Required Intervention
• Patient Sex: Unknown