MAUDE Adverse Event Report: ABBOTT MEDICAL EPIC PLUS; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number E200-33M

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 04/15/2023

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2023, an unknown mitral ring was chosen for implant.It was determined that the unknown ring was not effective and it was decided to implant a 31mm epic plus mitral valve instead.However, it was observed that the temperature indicator was activated on the valve.The physician decided to use a new 33mm epic mitral valve because they had only that size available.When they tried to use that valve, the holder of the valve was defective and it was not staying on the introducer.The valve fell off the holder prior to putting sutures through it and they are not able to push the valve into position as it kept falling off.So the physician decided to replace the valve with a new 29mm epic valve.The patient ended up with much longer bypass and cross clamp run and the patient was highly unstable coming off bypass and remained critically ill.A smaller size new 29mm epic valve was successfully implanted.The patient remained hemodynamically stable throughout the procedure.The patient was reported as stable.

Manufacturer Narrative

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

Manufacturer Narrative

An event of the valve holder being defective was reported.It was also reported that there was valve as fell off the holder prior to putting sutures and there was difficulty noted when placing the valve.The investigation found that the valve, valve holder and button holder had no anomalies when analyzed at abbott.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 determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• Brand Name: EPIC PLUS
• 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 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: 16904986
• MDR Text Key: 314936501
• Report Number: 2135147-2023-02031
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 05415067033109
• UDI-Public: 05415067033109
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: E200-33M
• Device Catalogue Number: E200-33M
• Device Lot Number: BR00034699
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/13/2022
• 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 Outcome(s): Other