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

Model Number BG3510-5-J

Device Problem Clumping in Device or Device Ingredient (1095)

Patient Problem Thromboembolism (2654)

Event Type  Injury  

Event Description

According to publication, "bioglue coronary embolism during open heart surgery", patient underwent type a aortic dissection, bioglue was used in the false lumen.Patient developed shock following the discontinuation of cardio-pulmonary bypass.Several additional procedures were performed.The surgeon performed thrombus aspiration with a thrombectomy catheter and retrieved a tiny amount of material; however the thrombus was not completely removed.Blood pressure increased and patient recovered from shock.Histologic examinations revealed that no atherosclerotic components, such as cholesterol or foam cells, were present in the embolic materials and they were consistent with histologic specimens of bioglue.As a result, the removed material was confirmed to be possibly fragments of the bioglue that had been used to repair the aortic dissection." lot number and date of event are unknown.

• Brand Name: BIOGLUE SYRINGE 5-PACK, 10 ML, JAPAN
• Type of Device: GLUE,SURGICAL,ARTERIES
• Manufacturer (Section D): ARTIVION, INC. ¿ KENNESAW; 1655 roberts blvd. nw; kennesaw GA 30144
• Manufacturer (Section G): ARTIVION, INC. ¿ KENNESAW; 1655 roberts blvd. nw; kennesaw GA 30144
• Manufacturer Contact: rochelle maney ; 1655 roberts blvd; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 14316853
• MDR Text Key: 293854854
• Report Number: 1063481-2022-00005
• 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,Study,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/22/2022

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?: No
• Distributor Facility Aware Date: 04/11/2022
• Initial Date Manufacturer Received: 04/11/2022
• Initial Date FDA Received: 05/07/2022
• Supplement Dates Manufacturer Received: 04/11/2022
• Supplement Dates FDA Received: 06/22/2022
• 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; Required Intervention
• Patient Age: 86 YR
• Patient Sex: Female