MAUDE Adverse Event Report: ABBOTT MEDICAL EPIC PLUS; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number	E200-27M
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	11/13/2025
Type of Reportable Event	Death
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 (b)(6) 2025, a 27mm epic plus mitral valve was chosen for a mitral valve replacement (mvr) surgery performed due to mitral valve stenosis (ms).After implanting the valve, a left ventricular rupture was confirmed.The valve was removed and a new sjm masters series valve expanded cuff was implanted.After the procedure, the heart rate and blood pressure did not recover and the patient was subsequently died.At the time of confirming the left ventricular rupture, multiple tears were observed in the ventricular wall.Although definitive evidence was lacking, it was possible that the stent post of 27mm epic plus mitral valve was struck the wall and caused the rupture.The cause of death was left ventricular rupture.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
Explant due to a left ventricular rupture with multiple tears after implantation of 27 mm epic plus mitral valve was reported.A new sjm masters series valve expanded cuff was implanted.However, the heart rate and blood pressure did not recover and the patient passed away.A returned device assessment 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 and medical review, the patient death appears to be related to procedural condition (a left ventricular rupture and multiple tears).However, it is difficult to determine with certainty the exact cause of the left ventricular rupture with multiple tears and whether procedural conditions contributed to it.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• Brand Name: EPIC PLUS
• 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: 23791141
• Report Number: 2135147-2025-07314
• Device Sequence Number: 5712782
• Product Code: LWR
• UDI-Device Identifier: 05415067033062
• UDI-Public: (01)05415067033062(17)290305
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P040021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 01/27/2026

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: E200-27M
• Device Catalogue Number: E200-27M
• Device Lot Number: BR00052153
• 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: 11/18/2025
• Supplement Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 01/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/06/2025
• 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: Required Intervention; Death
• Patient Age: 75 YR
• Patient Sex: Female