MAUDE Adverse Event Report: CRYOLIFE, INC. ¿ KENNESAW BIOGLUE SYRINGE 5-PACK, 10 ML, JAPAN; GLUE,SURGICAL,ARTERIES

Model Number BG3510-5-J

Device Problems Insufficient Information (3190); Migration (4003)

Patient Problem Embolus (1830)

Event Type  Injury  

Event Description

According to the initial report, the patient complained of precordial pain and came to the hospital because of suspicion of ischemic heart disease.Echocardiography revealed a false lumen image in the ascending aorta, and ct revealed a false lumen thrombotic occlusion type debakey ii acute aortic dissection.On the second day of hospitalization, chest and back pain appeared, and ct revealed a re-deviation, and surgery was performed.A crack was found on the dorsal side of the ascending aortic lumen, false lumen was fixed with bioglue, the excess portion was removed, and a band-like felt was fixed inside and outside the aortic wall to form a stump, and an artificial blood vessel was sewn on.Then, ascending aortic artificial blood vessel replacement was performed.On the 5th day after the operation, a negative t wave was detected in v2 to v6 on the electrocardiogram, echocardiography revealed asystole of the left ventricular apex, and a severe stenosis was observed on the left anterior descending branch on contrast ct.Intravascular echo on coronary angiography the embolus was not a thrombus or atheroma, but the internal echo was uniform and it seemed to be an artificial one.It was considered as a fragment of bioglue filled in the false lumen, which was consistent with the in vitro findings.The patient was discharged from the hospital on the 23rd day after surgery, and is now well without any problems in their daily life.

Manufacturer Narrative

According to the initial report, a 70-year-old female patient complained of precordial pain and went to the hospital due to suspicion of ischemic heart disease.An echocardiography revealed a false lumen image in the ascending aorta, and a ct revealed a false lumen thrombotic occlusion type debakey ii acute aortic dissection.On the second day of hospitalization, chest and back pain appeared, and ct revealed a re-deviation, and aortic replacement surgery was performed with bioglue applied within the false lumen.On the 5th day after the operation, echocardiography revealed asystole of the left ventricular apex, and a severe stenosis was observed on the left anterior descending branch on contrast ct.¿the embolus was not a thrombus or atheroma, but the internal echo was uniform and it seemed to be an artificial one.It was considered as a fragment of bioglue filled in the false lumen, which was consistent with the in vitro findings.¿ reoperation was performed, and she was discharged 23 days after surgery, and doing will without any issues.The following information about the reported event is unknown: if negative pressure was avoided during application and polymerization, and if the false lumen was overfilled.The report does not specify how or if the true lumen was protected during bioglue application.Protection by inserting sterile gauze to prevent bioglue from dripping into the true lumen or a balloon catheter to define a distal terminus is recommended to prevent bioglue from entering the true lumen via a distal re-entry point; bioglue that enters the true lumen may embolize to other vessels.Warning in the ifu states, ¿do not allow bioglue in either the uncured or polymerized form to contact circulation blood.Bioglue entering the circulation can result in local or vascular obstruction.¿ vessel obstruction is also listed in the ifu as a potential adverse event.There is insufficient information available to determine a definitive root cause for the reported event.However, obstruction of the left anterior descending artery caused by bioglue tracking along a false lumen extending into the coronary artery or embolization into the coronary true lumen remains a possibility.This report is being submitted as required by federal regulations and does not constitute an admission that the device caused or contributed to the reported event.Furthermore, this report reflects the event as alleged by the complainant and does not imply that the information reported to cryolife is accurate or has been confirmed by cryolife.

• Brand Name: BIOGLUE SYRINGE 5-PACK, 10 ML, JAPAN
• Type of Device: GLUE,SURGICAL,ARTERIES
• Manufacturer (Section D): CRYOLIFE, INC. ¿ KENNESAW; 1655 roberts blvd. nw; kennesaw GA 30144
• MDR Report Key: 10466228
• MDR Text Key: 204917140
• Report Number: 1063481-2020-00016
• 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: distributor,literature
• Type of Report: Initial,Followup
• Report Date: 10/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: BG3510-5-J
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/18/2020
• Initial Date FDA Received: 08/28/2020
• Supplement Dates Manufacturer Received: 08/18/2020
• Supplement Dates FDA Received: 10/05/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other