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

Catalog Number	E200-27M
Medical Device Problem Code	Incomplete Coaptation (2507)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2023
Type of Reportable Event	Malfunction
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) 2023, a 27mm epic plus mitral was selected for an implant.At the time of device preparation, the leaflets were moving normally when tested with a saline valve tester.During the procedure, upon saline test it was observed that the movement of the leaflets was not proper.The physician explanted the valve and replaced it with a non-abbott device.Heparin was administered during the procedure.The patient is stable.
Additional Manufacturer Narrative
An event of leaflets coaptation during procedure was reported.The valve was returned to abbott for analysis and the investigation found all three leaflets had limited mobility when manually manipulated and appeared to be dehydrated which precluded functional testing.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received, the root cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.
Event or Problem Description
N/a.

• 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: 18177928
• Report Number: 2135147-2023-05108
• Device Sequence Number: 15366946
• Product Code: LWR
• UDI-Device Identifier: 05415067033062
• UDI-Public: 05415067033062
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P040021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 12/20/2023

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 Catalogue Number: E200-27M
• Device Lot Number: 180763357
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/26/2023
• Supplement Date Received by Manufacturer: 12/11/2023
• Initial Report FDA Received Date: 11/20/2023
• Supplement Report FDA Received Date: 12/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2023
• 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: Required Intervention
• Patient Sex: Unknown