MAUDE Adverse Event Report: ABBOTT MEDICAL EPIC¿ SUPRA VALVE (AORTIC); HEART-VALVE, NON-ALLOGRAFT TISSUE

Catalog Number	ESP200-21
Medical Device Problem Code	Incomplete Coaptation (2507)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2023, a 21mm epic supra valve (serial: (b)(6)) was chosen for implantation into a 23mm native valve.During implantation, after completing the supra annular sutures, when the valve holder cap was removed and valve was tested, one of the leaflets was not attached properly.There was a gap in the leaflet just beyond its attachment.There was no tear in the leaflet or cusp.Leaflet tissue had not been manually manipulated or handled with any unprotected forceps or sharp instruments the valve was explanted and replaced with another 21mm epic supra valve.The patient remained hemodynamically stable throughout the procedure and is reported to be stable.There were no patient consequences and no clinically significant delay.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of a gap in the leaflet was reported.The valve was returned to abbott for analysis and the investigation found one of the leaflet had a tear.All three leaflets had limited mobility when manually manipulated and appeared to be dehydrated which precluded functional testing.Images received from the field appeared to show folded leaflet on the valve.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 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
It was reported that on (b)(6) 2023, a 21mm epic plus valve (serial: (b)(6)) was chosen for implantation into a 23mm native valve.During implantation, after completing the supra annular sutures, when the valve holder cap was removed and valve was tested, one of the leaflets was not attached properly.There was a gap in the leaflet just beyond its attachment.There was no tear in the leaflet or cusp.Leaflet tissue had not been manually manipulated or handled with any unprotected forceps or sharp instruments the valve was removed and replaced with another 21mm epic plus valve.The patient remained hemodynamically stable throughout the procedure and is reported to be stable.There were no patient consequences and no clinically significant delay.

• Brand Name: EPIC¿ SUPRA VALVE (AORTIC)
• 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: 18086060
• Report Number: 2135147-2023-04900
• Device Sequence Number: 6591155
• Product Code: LWR
• UDI-Device Identifier: 05415067033123
• UDI-Public: 05415067033123
• 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): 12/18/2023

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: ESP200-21
• Device Lot Number: BR00035331
• 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: 10/15/2023
• Supplement Date Received by Manufacturer: 12/11/2023
• Initial Report FDA Received Date: 11/07/2023
• Supplement Report FDA Received Date: 12/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2022
• 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
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 52 KG