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

Model Number	E100-27M-00
Medical Device Problem Codes	Perivalvular Leak (1457); Intravalvular regurgitation (4068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2022
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) 2022, a 27mm epic mitral valve was implanted.After the valve was implanted, it was observed on echocardiogram that there was a leak from the valve.The decision was made to remove the valve and replace it with another valve.The patient status was unknown.
Additional Manufacturer Narrative
An event leakage during the valve implantation was reported.The device was returned back to abbott for investigation and the sewing cuff is fully intact and the leaflet 1 was folded.No anomalies were found with the valve cusps.The valves performance was noted to be limited during functional testing upon return to abbott, however functional testing at the time of manufacturing indicated the valve functioned normally.This test ensures proper cuspal coaptation and hemodynamic performance.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications, including inspection for proper coaptation and effective orifice area.The cause of the reported event could not be conclusively determined, however it is possible the valve structure was damaged during implant or explant of the valve, which could have impacted the coaptation of the leaflets and led to the lowered valve performance.H6 medical device problem code: code 1457 removed.
Event or Problem Description
It was reported that on (b)(6) 2022, a 27mm epic mitral valve was implanted.After the valve was implanted, it was observed on echocardiogram that there was a leak from the valve.The decision was made to remove the valve and replace it with another valve.The patient status was unknown.Subsequent to the previously filed report, additional information was received that: the leak was observed through the valve itself.The unknown size replacement was implanted, and the procedure was finished without incident.Patient remained on bypass for the entire procedure.There was no clinically significant delay and no adverse effects.

• Brand Name: EPIC STENTED PORCINE HEART VALVE
• 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 #3014918977; edificio #44 calle 0, ave. 2; el coyol alajuela 1897- 4050; CS 1897-4050
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 15420143
• Report Number: 2135147-2022-01197
• Device Sequence Number: 19488111
• Product Code: LWR
• UDI-Device Identifier: 05414734055574
• UDI-Public: 05414734055574
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P040021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/01/2023
• Device Model Number: E100-27M-00
• Device Catalogue Number: E100-27M-00
• Device Lot Number: BR00021100
• 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: 08/22/2022
• Supplement Date Received by Manufacturer: 11/30/2022
• Initial Report FDA Received Date: 09/14/2022
• Supplement Report FDA Received Date: 12/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/02/2019
• 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