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 Unspecified Tissue Injury (4559)

Event Date 02/09/2024

Event Type  Injury  

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 (b)(6) 2024, a 21mm epic max valve was chosen for implant in a 77-year-old woman.During the procedure, it was noted that the corresponding 21mm epic max replica end of the sizer was difficult to pass through the sinotubular junction (stj) and in the process of forcing the sizer through the stj there was an injury caused to the aorta.Despite the difficulties in passing the 21mm epic max replica end of the sizer through the stj the physician decided to implant an epic max 21mm valve.The physician had difficulty seating the epic max 21mm valve on top of the annulus and had to patch the aorta to fit the valve.When the patient was taken off cardiopulmonary bypass, there were concerns about a blocked right coronary artery, so a saphenous vein graft was taken and bypassed to the right coronary artery.There continued to be difficulty separating from cardiopulmonary bypass so an internal mammary artery was taken and bypassed to the left anterior descending (lad) coronary artery.The patient continued to have difficulty separating from cardiopulmonary bypass, so she was placed on extracorporeal membrane oxygenation (ecmo) and transferred to cardiovascular intensive care unit (cvicu).However, several days later the patient passed away.

Manufacturer Narrative

An event of e1000 sizer was difficult to pass through the sinotubular junction and injury to the aorta was reported.A returned device assessment including a dimensional analysis of the sizer set could not be performed since the device was not returned for analysis.Information from the field indicated that patient had a low lying coronary anatomy and valve may have partially blocked the right coronary, and which may lead to the reported incident.Based on the information provided, the cause of reported incident could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

Event Description

It was reported that on (b)(6)2024, a 21mm epic max valve was chosen for implant.During the procedure, it was noted that the corresponding 21mm epic max replica end of the sizer was difficult to pass through the sinotubular junction (stj) and in the process of forcing the sizer through the stj, there was an injury caused to the aorta.Despite the difficulties in passing the 21mm epic max replica end of the sizer through the stj, the physician decided to implant an epic max 21mm valve.The physician had difficulty seating the epic max 21mm valve on top of the annulus and had to patch the aorta to fit the valve.When the patient was taken off cardiopulmonary bypass, there were concerns about a blocked right coronary artery, so a saphenous vein graft was taken and bypassed to the right coronary artery.There continued to be difficulty separating from cardiopulmonary bypass so an internal mammary artery was taken and bypassed to the left anterior descending (lad) coronary artery.The patient continued to have difficulty separating from cardiopulmonary bypass, so the patient was placed on extracorporeal membrane oxygenation (ecmo) and transferred to cardiovascular intensive care unit (cvicu).However, several days later the patient passed away.

• 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: 18852505
• MDR Text Key: 337070143
• Report Number: 2135147-2024-01028
• 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: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: EMAX-1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/16/2024
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female