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

Model Number	E200-25M
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2026, a 25mm epic plus mitral valve was chosen for a procedure.During procedure, a sewing ring tear was noted.
Event or Problem Description
It was reported that on (b)(6) 2026, a 25mm epic plus mitral valve was chosen for a procedure.During procedure, a sewing ring tear was noted.A new 25mm epic plus mitral valve was chosen and completed the procedure.There was no delay in the procedure.The patient was reported discharged.
Additional Manufacturer Narrative
An event of sewing ring tear was reported.The device was returned to abbott for evaluation, and the sewing cuff was noted to have a torn damage.All three stent posts were normal in appearance.No other anomalies were found.The device history record was also reviewed to verify that all manufacturing and inspection steps were completed and that the product met applicable specifications.Field indicated that the tear was observed during the procedure.Possible contributing factors may include excessive suture tension, multiple re-suturing attempts and/or inadvertent handling-related stress on the cuff during the procedure.There is no indication of a product quality issue related to manufacturing, design, or labeling.

• 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: 24648939
• Report Number: 2135147-2026-01750
• Device Sequence Number: 18615644
• Product Code: LWR
• UDI-Device Identifier: 05415067033048
• UDI-Public: (01)05415067033048(17)290219
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 05/14/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: E200-25M
• Device Catalogue Number: E200-25M
• Device Lot Number: BR00051056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2026
• Supplement Date Received by Manufacturer: 05/08/2026
• Initial Report FDA Received Date: 03/20/2026
• Supplement Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2025
• 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
• Patient Sex: Unknown