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

Model Number BG UNK

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Aneurysm (1708); Pseudoaneurysm (2605)

Event Type  Injury  

Event Description

According to the initial report received, "while this was published in the journal of japanese society of vascular surgery.2021;30(supplement), it looks like these cases were presented at the 49th annual meeting of the japanese society of vascular surgery.Bioglue used for central amputation stump plasty in all 3 cases.Case 1: (b)(6) year-old female.Ascending arch aortic replacement.Ct scan 2 years later showed pseudoaneurysm.No reoperation needed, pseudoaneurysm has not enlarged or ruptured.Case 2: (b)(6) year-old female.Ascending partial arch aortic replacement.One year, 7 months later a root pseudoaneurysm formed and emergency surgery was performed.Case 3: (b)(6) year-old male.Ascending arch aortic replacement.3 years later ct scan showed root aneurysm.Reoperation was performed 4 years and 3 months after the original procedure.".

• 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: 12372048
• MDR Text Key: 268458568
• Report Number: 1063481-2021-00026
• 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: literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: BG UNK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/31/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other