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

Catalog Number ESP100-21

Device Problem Incomplete Coaptation (2507)

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

Event Date 02/11/2023

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 21mm epic supra valve was selected for implantation.During the procedure, part of the valve cusps turned up while rinsing.The valve was deemed acceptable, and was placed into the annulus.It was noted that the cusps did no coapt properly, and the device was replaced with a 19mm epic supra valve.It was noted the 19mm device valve cusps also turned up prior to implantation.The 19mm device was implanted successfully, but after the procedure, it was noted by transesophageal echocardiogram (tee) that the patient had moderate to severe regurgitation.The physician was about to explant the valve when the regurgitation spontaneously resolved.The patient had been monitored and no additional complications.It is believed that the leaflet creased prior to implant, causing the regurgitation, and after implantation, the crease dissolved and the valve began functioning properly.The patient is reported to be stable.There was no clinically significant delay in procedure and no adverse patient effects.No additional information was provided.

Manufacturer Narrative

An event of the valve leaflets not being coapting properly was reported.A returned device assessment to see if there were any valve abnormalities could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications, including functional testing, prior to release from abbott.This functional test ensures proper cuspal coaptation and hemodynamic performance before commercial release.The free state of the leaflets, without physiological pressure applied, is not indicative of actual leaflet coaptation or valve function.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• Brand Name: EPIC¿ SUPRA VALVE (AORTIC)
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16505431
• MDR Text Key: 311040571
• Report Number: 2135147-2023-01071
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 03/23/2023

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 Expiration Date: 03/04/2024
• Device Catalogue Number: ESP100-21
• Device Lot Number: BR00024459
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/13/2023
• Initial Date FDA Received: 03/08/2023
• Supplement Dates Manufacturer Received: 03/19/2023
• Supplement Dates FDA Received: 03/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2020
• 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