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

Catalog Number E200-33M

Device Problem Material Puncture/Hole (1504)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/20/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that on (b)(6) 2023, a 33mm epic plus mitral valve was chosen for implant during a mitral valve replacement.The valve size was chosen after epic plus heart valve sizer set was used to size the mitral annulus.After the valve was successfully implanted, saline testing was conducted, and it was noted that there was a leak in one of the leaflets towards the annular area.The leak was believed to be caused by a needle prick.The valve was explanted and replaced with a 31mm epic plus mitral valve.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.The patient status was reported as stable and was discharged.

Event Description

It was reported that on (b)(6) 2023, a 33mm epic plus mitral valve was chosen for implant during a mitral valve replacement.The valve size was chosen after epic plus heart valve sizer set was used to size the mitral annulus.After the valve was successfully implanted, saline testing was conducted, and it was noted that there was a leak in one of the leaflets towards the annular area.The leak was believed to be caused by a needle prick as there was a hole seen in the leaflet.There were no instruments in contact with the valve apart from the valve holder during the procedure.The valve was explanted and replaced with a 31mm epic plus mitral valve.The patient remained hemodynamically stable throughout the procedure.There was no clinically significant delay in procedure and no adverse patient effects.The patient status was reported as stable and was discharged.Subsequent to the previously filed report, additional information was received that there was a hole seen in the leaflet during saline testing during the procedure.There were no instruments in contact with the valve apart from the valve holder during the procedure.

Manufacturer Narrative

An event of hole seen in the leaflet could not confirm.The device was returned to abbott for investigation.The investigation found that the sewing cuff was be fully intact and all cusps were mobile.All three stent posts were normal in appearance.No tears were observed.The valve was sent for functional testing at the engineering test lab.Functional testing revealed leaflet function was considered abnormal as one of the leaflets appeared to be co-apting low along with an apparent central jet.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.This includes a check to ensure the valve during the manufacturing and final valve packaging.The cause of the reported event could not be conclusively.

• Brand Name: EPIC PLUS
• Type of Device: 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: 17541596
• MDR Text Key: 321079684
• Report Number: 2135147-2023-03535
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05415067033109
• UDI-Public: 05415067033109
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P040021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/13/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: E200-33M
• Device Lot Number: BR00033508
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/20/2023
• Initial Date FDA Received: 08/14/2023
• Supplement Dates Manufacturer Received: 10/06/2023
• Supplement Dates FDA Received: 10/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1