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

Model Number BG3510-5-J

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Stenosis (2263)

Event Type  Injury  

Event Description

According to the publication, surgical glue-induced left main trunk stenosis removed by directional coronary atherectomy: a (b)(6) man underwent aortic repair for acute aortic dissection.The pseudolumen of the valsalva sinus was reapproximated with bioglue by placing a sponge inside of it to prevent the bioglue from entering.Postoperative contrast-enhanced computed tomography showed stenosis of the left main trunk.Directional coronary atherectomy was performed; complete release of the stenosis was achieved.Various fragments retrieved from the left main trunk were pathologically consistent with bioglue.When we reapproximated the dissected aortic wall, inserting a sponge into the aorta did not prevent the surgical glue from entering.Directional coronary atherectomy was a good therapeutic option to treat glue-induced coronary artery stenosis.

Event Description

According to the publication, surgical glue-induced left main trunk stenosis removed by directional coronary atherectomy: a 55-year-old man underwent aortic repair for acute aortic dissection.The pseudolumen of the valsalva sinus was reapproximated with bioglue by placing a sponge inside of it to prevent the bioglue from entering.Postoperative contrast-enhanced computed tomography showed stenosis of the left main trunk.Directional coronary atherectomy was performed; complete release of the stenosis was achieved.Various fragments retrieved from the left main trunk were pathologically consistent with bioglue.When we reapproximated the dissected aortic wall, inserting a sponge into the aorta did not prevent the surgical glue from entering.Directional coronary atherectomy was a good therapeutic option to treat glue-induced coronary artery stenosis.

• Brand Name: BIOGLUE SYRINGE 5-PACK, 10 ML, JAPAN
• Type of Device: GLUE,SURGICAL,ARTERIES
• 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: rochelle maney ; 1655 roberts blvd., nw; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 12819840
• MDR Text Key: 281999794
• Report Number: 1063481-2021-00037
• 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,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/19/2022

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 Model Number: BG3510-5-J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/20/2021
• Initial Date Manufacturer Received: 10/20/2021
• Initial Date FDA Received: 11/16/2021
• Supplement Dates Manufacturer Received: 10/20/2021
• Supplement Dates FDA Received: 01/19/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 55 YR
• Patient Sex: Male