MAUDE Adverse Event Report: ABBOTT MEDICAL BIOCOR/EPIC SIZER SET; SIZER, HEART-VALVE, PROSTHESIS

Catalog Number EMAX-1000

Device Problem Patient Device Interaction Problem (4001)

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

Event Date 02/22/2024

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 21 february 2024, a 25mm epic max valve was chosen for a procedure using epic max heart valve sizer set.The patient had an non-abbott valve implanted 2 prior and had endocarditis which required a device replacement.The previously implanted non-abbott transcatheter valve was removed.It was noted that the sizer was bulky and it was possible to get the replica end of the 25 mm sizer down to the annulus.The replica end of the sizer subsequently got stuck at the level of the annulus and there was extreme difficulty removing the sizer from the aortic root.The sizer was hard plastic with no flex, it nearly torn the aorta when attempting to remove the sizer.A small segment of patient's ascending aorta had to be replaced with a synthetic graft material using an aortoplasty due to poor native tissue quality (calcification and friable tissue) in order to achieve a hemostatic closure of the aorta.The 25 mm epic max valve was successfully implanted.The physician mentioned there was no issue with the implanted valve.There was a delay of 5-10 minutes in the procedure due to this issue.It took extraordinarily long for the patient's heart to begin contracting normally as they were coming off bypass, i.E.~2 hours.The physician mentioned there was no issue with the implanted valve.The patient was reported as stable.The patient was discharge to a skilled nursing facility in stable condition.

Manufacturer Narrative

An event of sizer set being too bulky was reported.A returned device assessment including a dimensional analysis of the sizer set could not be performed since the device was not returned.Information from the field indicated that the replica end of the sizer subsequently got stuck at the level of the annulus and there was extreme difficulty removing the sizer from the aortic root.Based on the information provided, the cause of the event could not conclusively be determined.

• Brand Name: BIOCOR/EPIC SIZER SET
• Type of Device: SIZER, HEART-VALVE, PROSTHESIS
• 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: 18923502
• MDR Text Key: 337899504
• Report Number: 2135147-2024-01200
• Device Sequence Number: 1
• Product Code: DTI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 03/29/2024

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: EMAX-1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/22/2024
• Initial Date FDA Received: 03/18/2024
• Supplement Dates Manufacturer Received: 03/28/2024
• Supplement Dates FDA Received: 03/29/2024
• Was Device Evaluated by Manufacturer?: No
• 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
• Treatment: EPIC MAX VALVE, EMAX-25
• Patient Age: 69 YR
• Patient Sex: Male