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

Model Number BG3510-5-J

Device Problem Unintended Movement (3026)

Patient Problem Thromboembolism (2654)

Event Type  Injury  

Event Description

Per the article ¿bioglue cerebral embolism following acute type a aortic dissection repair¿ (yamasaki m et al, 2021): ¿the case of a (b)(6) male with ataad who successfully underwent total arch replacement.Five days after the surgery, he collapsed due to right hemiplegia.We immediately performed cerebral thrombectomy and removed the thrombotic embolus caused by bioglue, which was used to obliterate the false lumen of the dissected aorta during ataad repair.¿ pathology reports revealed the material with fresh thrombus to be consistent with bioglue.The authors believe ¿secondary mobilization of glue particles through suture-line needle holes¿ may have caused the event even though they state they cannot prove it.The lot number is unknown.

• 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
• 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: 12365505
• MDR Text Key: 268065741
• Report Number: 1063481-2021-00025
• Device Sequence Number: 1
• Product Code: MUQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/18/2021

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?: No
• Distributor Facility Aware Date: 07/28/2021
• Initial Date Manufacturer Received: 07/28/2021
• Initial Date FDA Received: 08/25/2021
• Supplement Dates Manufacturer Received: 07/28/2021
• Supplement Dates FDA Received: 10/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 61 YR