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

Catalog Number E100-27M

Device Problems Product Quality Problem (1506); Improper or Incorrect Procedure or Method (2017); Detachment of Device or Device Component (2907); Packaging Problem (3007)

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

Event Date 01/29/2024

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for evaluation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.Na.

Event Description

It was reported that on 29 january 2024, a 27mm epic valve was chosen for implantation into a mitral valve.During preparation, the valve handle could not be inserted to remove the valve from the jar.The valve was removed with forceps.It was noted that one of tabs of the valve holder was unstable and the retaining suture was loose.During procedure, the handle also failed to insert into the holder.The epic valve was still able to be implanted utilizing forceps.The patient remained hemodynamically stable throughout the procedure.There were no patient consequences or clinically significant delay.The patient is reported to be stable.

Manufacturer Narrative

An event of difficulty inserting the valve handle and removing valve from jar was reported.It was reported that the valve was removed with forceps.The investigation confirmed the device met specifications when analyzed at abbott.The returned handle was able to fit into the valve holder when tested using a test plug.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 holder plug is in place and that the valve holder is correctly placed on the valve during the manufacturing and final valve packaging.The cause of the reported event could not be conclusively.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Please note that per the instructions for use, "do not handle the valve with unprotected forceps or sharp instruments.Never handle the leaflet tissue.".

• Brand Name: EPIC¿ VALVE (MITRAL)
• 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 #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: 18744190
• MDR Text Key: 336749338
• Report Number: 2135147-2024-00777
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05414734027526
• UDI-Public: (01)05414734027526(17)270816(10)9231054
• 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: 04/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: E100-27M
• Device Lot Number: 9231054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2023
• 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