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

Catalog Number E100-29M

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 04/08/2023

Event Type  malfunction  

Event Description

It was reported that on (b)(6) 2023, a 29mm epic mitral valve was chosen for implant.During procedure when descending the valve into the patient's anatomy, the plastic support valve holder broke into 2-3 pieces.One of the pieces fell into the left ventricle.The piece was removed without difficulty, and the valve was and to be successfully implanted.There were no adverse consequences for the patient.There was no clinically significant delay in the procedure and the patient remained hemodynamically stable throughout.The patient is stable and in conventional hospitalization.

Manufacturer Narrative

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

Manufacturer Narrative

An event valve holder being damaged and broken during the procedure was reported.The valve holder was returned to abbott, and the investigation confirmed that the spool and plug were reversed on the base, with the spool in the location of the plug and the plug in the location of the spool.How or when the spool and plug became reversed could not be conclusively determined; however, it is consistent with the spool and plug being replaced in the incorrect location after the valve holder was disassembled in the field.There was damage noted in the hex cavity of both the spool and the plug.How or when the damage occurred could not be conclusively determined; however, it is consistent with damage during the implant procedure.Even though this could not be confirmed, the pattern of damage in the hexagonal cavity of the holder appears consistent with the use of an alternative tool.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications at the time of commercialization, which includes inspection of the holder and inspection of the final valve assembly.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: 16950477
• MDR Text Key: 315446852
• Report Number: 2135147-2023-02161
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 08/29/2023

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: E100-29M
• Device Lot Number: 8823209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/25/2023
• Initial Date FDA Received: 05/17/2023
• Supplement Dates Manufacturer Received: 08/22/2023
• Supplement Dates FDA Received: 08/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2022
• 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