MAUDE Adverse Event Report: CRYOLIFE, INC. ¿ KENNESAW BIOGLUE - UNKNOWN CONFIGURATION; GLUE,SURGICAL,ARTERIES

Model Number BG UNK

Device Problem Insufficient Information (3190)

Patient Problem Reaction to Medicinal Component of Device (4574)

Event Type  Injury  

Event Description

According to publication, "sterile peri-graft abscess formation following aortic replacement: a word of caution for usage of bioglue" nurcan yilmaz , tornike sologashvili, christoph huber and mustafa cikirikcioglu, "bioglue was applied to the anastomotic suture line during an ascending aortic and hemiarch replacement for acute type a aortic dissection and subsequently developed a fever and inflammatory reaction resulting in further interventions including draining of the peri-graft site with a histopathologic analysis of the peri-graft process showing a fibrin-inflammatory reaction without microorganisms.Ten days after intervention the remainder of the recovery was uneventful.".

• Brand Name: BIOGLUE - UNKNOWN CONFIGURATION
• Type of Device: GLUE,SURGICAL,ARTERIES
• Manufacturer (Section D): CRYOLIFE, INC. ¿ KENNESAW; 1655 roberts blvd. nw; kennesaw GA 30144
• Manufacturer (Section G): CRYOLIFE, INC. ¿ KENNESAW; 1655 roberts blvd. nw; kennesaw GA 30144
• Manufacturer Contact: rochelle maney ; 1655 roberts blvd; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 12804996
• MDR Text Key: 282525283
• Report Number: 1063481-2021-00036
• Device Sequence Number: 1
• Product Code: MUQ
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P010003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/10/2022

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: BG UNK
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 10/21/2021
• Initial Date Manufacturer Received: 10/21/2021
• Initial Date FDA Received: 11/12/2021
• Supplement Dates Manufacturer Received: 10/21/2021
• Supplement Dates FDA Received: 01/10/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male