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

Model Number	E200-31M
Medical Device Problem Codes	Nonstandard Device (1420); Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Heart Failure/Congestive Heart Failure (4446)
Date of Event	03/06/2025
Type of Reportable Event	Death
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) 2025, a 31mm epic valve was selected for implant.During the procedure, after parachuting the valvue down into the annulus, and removing the valve from the holder, it was noted that there was a bent leaflet on the valve.The fold was noted on the free edge of the veil, near its junction with the pole.It was attributed that this was due to the calcification of the native valve.The valve was removed and another abbott valve was used to complete the procedure.The physician alleged that there was "hardening" on the abbott valve.The patient remained hemodynamically stable throughout the procedure.The physician doesn't believe the patient or user experienced adverse health consequences due to the performance of the product.On the same day, the patient passing away.The physician classifies this death as being related to the procedure and the patient¿s comorbidities.The implanter does not classify that the death is related to the function/performance of the implanted device.
Additional Manufacturer Narrative
It was reported that after removing the holder when parachuting the epic mitral valve it was discovered that there was a fold in the epic mitral valve leaflet with calcification.The valve was replaced with another 31 mm epic valve.However, the patient expired on the same day.Also reported that the physician doesn't believe the patient or user experienced adverse health consequences due to the performance of the product.The physician classified patient death as being related to the procedure and the patient¿s comorbidities.The device was returned to abbott for investigation and no anomalies were found with the valve cusps.The valve was sent for pathological testing and the investigation found that there was a possible fold and incomplete coaptation at cusp 1.The inflow and outflow surfaces of all three cusps have scattered non-adherent fungal hyphae.There was no inflammation or significant calcifications present.The valve was sent for functional testing at the engineering test lab.Hydrodynamic examination indicated the valve met functional specification.A review of functional hydrodynamic testing of the returned valve was performed and showed normal valve function with normal symmetrical full opening of all three cusps and symmetrical coaptation with no evidence of a central gap.Based on the review of the video during hydrodynamic testing all three leaflets appeared normal and functioning normally despite the appearance of a fold on photography.During functional testing the fold was no longer present.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, including functional testing to ensure proper leaflet coaptation and hemodynamic performance, and the product met all specifications.Based on the medical review performed at abbott, the exact cause of patient death cannot be determined from the information provided.The cause of the reported leaflet deformation and patient death could not be conclusively determined.However, it was reported that the patient death was related to the procedure and patient comorbidities.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
Event or Problem Description
It was reported that on (b)(6) 2025, a 31mm epic valve was selected for implant.During the procedure, after parachuting the valve down into the annulus, and removing the valve from the holder, it was noted that there was a bent leaflet on the valve.The fold was noted on the free edge of the veil, near its junction with the pole.It was attributed that this was due to the calcification of the native valve.The valve was removed and another abbott valve was used to complete the procedure.The physician alleged that there was "hardening" on the abbott valve.The patient remained hemodynamically stable throughout the procedure.The physician doesn't believe the patient or user experienced adverse health consequences due to the performance of the product.On the same day, the patient passing away.The physician classifies this death as being related to the procedure and the patient¿s comorbidities.The implanter does not classify that the death is related to the function/performance of the implanted 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: 21885752
• Report Number: 2135147-2025-02131
• Device Sequence Number: 18167242
• Product Code: LWR
• UDI-Device Identifier: 05415067033093
• UDI-Public: (01)05415067033093(17)270305
• 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: 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): 07/29/2025

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: E200-31M
• Device Catalogue Number: E200-31M
• Device Lot Number: BR00037113
• 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: 03/27/2025
• Supplement Date Received by Manufacturer: 07/21/2025
• Initial Report FDA Received Date: 04/22/2025
• Supplement Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2023
• 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: Death
• Patient Sex: Unknown