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

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Death (1802); Occlusion (1984)

Event Type  Death  

Event Description

According to the report from the cryolife representative, he spoke with dr.(b)(6) at (b)(6).Dr.(b)(6) asked if we had ever had a report of bioglue getting inside and occluding a coronary artery following an aortic dissection repair.He said he used bioglue over a year ago in an extremely challenging aortic dissection case where without bioglue he may not have been able to save the patient's life.He used bioglue on the proximal end to reapproximate the layers.He protected the true lumen with gauze to ensure the bioglue didn't get intraluminal.The patient came back several months later with an occluded coronary and eventually passed away.He never said it was bioglue that caused the problem and couldn't think of how bioglue would have gotten inside the coronary but was curious if we had ever heard of this happening before.

Event Description

According to the report from the cryolife representative, he spoke with dr.Scholz at aats.Dr.Scholz asked if we had ever had a report of bioglue getting inside and occluding a coronary artery following an aortic dissection repair.He said he used bioglue over a year ago in an extremely challenging aortic dissection case where without bioglue he may not have been able to save the patient's life.He used bioglue on the proximal end to reapproximate the layers.He protected the true lumen with gauze to ensure the bioglue didn't get intraluminal.The patient came back several months later with an occluded coronary and eventually passed away.He never said it was bioglue that caused the problem and couldn't think of how bioglue would have gotten inside the coronary but was curious if we had ever heard of this happening before.Field assurance received an email from dr.Scholz which stated, "in reviewing the final autopsy report there is no mention of bio-glue.Excuse my misunderstanding." if bioglue had been the cause of the occluded coronary artery there would have been mention of it in the final autopsy.

Manufacturer Narrative

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

Manufacturer Narrative

According to the field assurance notification form dr.(b)(6) from (b)(6) stopped by the cryolife booth.He asked if cryolife had ever had a report of bioglue getting inside and occluding a coronary artery following an aortic dissection repair.He said he used bioglue over a year ago in an extremely challenging aortic dissection case where without bioglue he may not have been able to save the patient's life.He used bioglue on the proximal end to reapproximate the layers.He protected the true lumen with gauze to ensure the bioglue didn't get intraluminal.The patient came back several months later with an occluded coronary and eventually passed away.He never said it was bioglue that caused the problem and couldn't think of how bioglue would have gotten inside the coronary but was curious if we had ever heard of this happening before.He is retired now but wanted to stop by to discuss with us.Emails were sent to dr.(b)(6) on (b)(4) 2015 requesting additional information on the event.On (b)(4) 2015 field assurance received an email from dr.(b)(6) which stated, "in reviewing the final autopsy report there is no mention of bio-glue.Excuse my misunderstanding." given these findings, bioglue was not mentioned in the final autopsy report; therefore, the complaint will be voided.

• Brand Name: BIOGLUE SURGICAL ADHESIVE
• Type of Device: SURGICAL ADHESIVE
• 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: 4737628
• MDR Text Key: 5703075
• Report Number: 1063481-2015-00056
• Device Sequence Number: 1
• Product Code: MUQ
• Combination Product (y/n): N
• PMA/PMN Number: P010003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Death