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

Catalog Number E100-31M

Device Problem Incomplete Coaptation (2507)

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

Event Date 07/27/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that on (b)(6) 2023, a 31mm epic mitral valve was chosen for implant.The valve was implanted, but the shape of one of the valve cusps was distorted, and there was an incomplete coaptation with the cusp.The valve was removed and replaced with a 29mm non-abbott valve, and the operation was completed successfully.There was no clinically significant delay in procedure and no adverse patient effects reported.

Manufacturer Narrative

An event of distorted cusp and incomplete coaptation was reported.The investigation found that all three cusps were mobile.A central jet was found during functional testing upon return of the valve to abbott.Functional testing at the time of manufacturing indicated the valve functioned normally.The photographs received from field appeared to show the inflow side of the mitral valve in-situ after valve seating but prior to knot tying as well as after valve removal.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 form abbott.The cause of the reported event could not be conclusively determined.It is possible the valve structure was damaged during implant or explant of the valve, which could have impacted the coaptation of the cusps, causing the central jet noted.There is no indication of a product quality issue with respect to labeling, design, or manufacturing of the device.

• 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: 17586518
• MDR Text Key: 321566892
• Report Number: 2135147-2023-03636
• 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: 11/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: E100-31M
• Device Lot Number: BR00034082
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2022
• 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
• Patient Age: 84 YR
• Patient Sex: Male