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

Catalog Number	E200-27M
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Perforation (2001); Heart Failure/Congestive Heart Failure (4446)
Date of Event	07/02/2024
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 (b)(6) 2024, a 27mm epic plus valve was implanted.After the cardiopulmonary bypass operation, the patient experienced a decrease in left ventricular contractile force, and it was discovered that the left heart had ruptured.It was believed that the cause of the heart rupture was due to weakness of the free wall of the left ventricle.The patient was returned to surgery to have the epic valve removed.The valve was replaced with another 27mm epic plus valve.A pericardial patch was applied to the free wall of the left ventricle.After the second operation, the patient again experienced a decrease in left ventricular contractile force, and it was discovered that the cardiac rupture had recurred.The patient was returned to surgery, and the second valve was removed.The physician believed that the cause of the heart rupturing again was due to not enough reinforcement from the pericardial patch.The valve was replaced with a 25mm epic plus mitral valve, and the procedure was completed.The patient was reported to be recovering.The patient was reported as stable.
Additional Manufacturer Narrative
An event of left ventricle rupture was reported after implant.Information from field indicated that the cause of the heart rupture was due to weakness of the free wall of the left ventricle.The investigation found that sewing cuff was intact and contained blood/body fluids with sutures on it.All three stent posts were normal in appearance.All three leaflets were flexible and contained no tears, perforations or anomalies.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.The cause of the reported event could not be conclusively determined.However, it was noted that valve did not caused or contributed to the rupture.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) 2024, a 27mm epic plus valve was implanted.The native mitral annulus diameter was 34mm.After the cardiopulmonary bypass operation, the patient experienced a decrease in left ventricular contractile force, and it was discovered that the left heart had ruptured.It was believed that the cause of the heart rupture was due to weakness of the free wall of the left ventricle.The patient was returned to surgery to have the epic valve removed.The valve was replaced with another 27mm epic plus valve.A pericardial patch was applied to the free wall of the left ventricle.After the second operation, the patient again experienced a decrease in left ventricular contractile force, and it was discovered that the cardiac rupture had recurred.The patient was returned to surgery, and the second valve was removed.The physician believed that the cause of the heart rupturing again was due to not enough reinforcement from the pericardial patch.The valve was replaced with a 25mm epic plus mitral valve, and the procedure was completed.The patient was reported to be recovering.The patient was reported as stable.

• 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: 19841424
• Report Number: 2135147-2024-03642
• Device Sequence Number: 12679049
• Product Code: LWR
• UDI-Device Identifier: 05415067033062
• UDI-Public: (01)05415067033062(17)280310(10)BR00043665
• 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: 2024
• Device Explanted Year: 2024
• 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): 08/23/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: E200-27M
• Device Lot Number: BR00043665
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/03/2024
• Supplement Date Received by Manufacturer: 08/07/2024
• Initial Report FDA Received Date: 07/26/2024
• Supplement Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/11/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: EPIC PLUS MITRAL VALVE, E200-27M, SN (B)(6).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male