MAUDE Adverse Event Report: CRYOLIFE, INC. BIOGLUE SURGICAL ADHESIVE; SURGICAL GLUE

Model Number BG3510-5-J

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Chest Pain (1776); Vascular Dissection (3160)

Event Type  Injury  

Event Description

According to the report, "an aortic dissection was reached until aortic root and left coronary artery." bioglue was used in an ascending aorta replacement surgery for the aortic dissection and was applied to the proximal false lumen.Bioglue was also applied around the coronary ostia.The surgeon inserted a nelaton catheter into the lumen of the left main trunk (lmt), but because the lmt was larger than the diameter of the catheter, bioglue may have caused compression/stenosis of the coronary ostia.As the patient complained of chest pain, percutaneous coronary intervention was performed and the patient recovered.

Manufacturer Narrative

This investigation is currently ongoing.Any additional information will be provided in the follow-up report.

Manufacturer Narrative

Corrected date: "date of report", was corrected to 12/17/2013.According to the report, "an aortic dissection was reached until aortic root and left coronary artery." bioglue was used in an ascending aorta replacement surgery for the aortic dissection and it was applied to proximal false lumen.Bioglue was also applied around the coronary ostia.The surgeon inserted a nelaton catheter into the lumen of the left main trunk (lmt), but because the lmt was larger than the diameter of the catheter, bioglue may have caused compression/stenosis of the coronary ostia.As the patient complained of chest pain, percutaneous coronary intervention was performed and the patient recovered.A review of possible lot numbers was performed and it was confirmed that all records were controlled, available for review and met all specifications.A review of available information was performed.From the information provided, it appears that bioglue entered the false lumen extending into the left main coronary artery, causing compression of the coronary ostium and/or the lumen of the left main coronary artery resulting in obstructed coronary bloodflow.The provided information indicates that the surgeon attempted to protect the coronary artery with a catheter.However, it was smaller than the coronary artery diameter.The intent of using a catheter in the coronary artery is to maintain patency of the true lumen by preventing bioglue entry into the false lumen.In order to accomplish this, the catheter must be of sufficient size to fill the true lumen and close off the false lumen.Instructions are included in bioglue's instructions for use describing use of a catheter to protect the coronary arteries.

Event Description

According to the report, "an aortic dissection was reached until aortic root and left coronary artery." bioglue was used in an ascending aorta replacement surgery for the aortic dissection and it was applied to proximal false lumen.Bioglue was also applied around the coronary ostia.The surgeon inserted a nelaton catheter into the lumen of the left main trunk (lmt), but because the lmt was larger than the diameter of the catheter, bioglue may have caused compression/stenosis of the coronary ostia.As the patient complained of chest pain, percutaneous coronary intervention was performed and the patient recovered.

• Brand Name: BIOGLUE SURGICAL ADHESIVE
• Type of Device: SURGICAL GLUE
• Manufacturer (Section D): CRYOLIFE, INC.; 1655 roberts blvd., nw; kennesaw GA 30144
• Manufacturer (Section G): CRYOLIFE, INC.; 1655 roberts blvd., nw; kennesaw GA 30144
• Manufacturer Contact: sandra o'reilly ; 1655 roberts blvd., nw; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 3548783
• MDR Text Key: 4053788
• Report Number: 1063481-2014-00001
• Device Sequence Number: 1
• Product Code: MUQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P010003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/17/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: BG3510-5-J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/17/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other