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 Problems Inflammation (1932); Pseudoaneurysm (2605)

Event Type  Injury  

Event Description

According to publication, ¿a case of central anastomotic rupture after acute aortic dissection due to bioglue.¿ (b)(6) year-old female underwent aad repair with a thin layer of bioglue applied to false lumen.8 months later ct showed ruptured central anastomotic aneurysm.Urgent pseudoaneurysm resection and closure of rupture was performed.Intraoperative pathological findings at time of reoperation showed infiltration of inflammatory cells that were not confirmed at the original aad repair surgery.The authors speculate that bioglue caused inflammation of tissue around the aorta causing the pseudoaneurysm formation.

• 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: 11944338
• MDR Text Key: 254540243
• Report Number: 1063481-2021-00020
• 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: 08/02/2021

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/11/2021
• Initial Date Manufacturer Received: 05/11/2021
• Initial Date FDA Received: 06/05/2021
• Supplement Dates Manufacturer Received: 05/11/2021
• Supplement Dates FDA Received: 08/02/2021
• 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: 64 YR