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

Model Number BG3510-5-J

Device Problems Material Separation (1562); Patient Device Interaction Problem (4001)

Patient Problems Aneurysm (1708); Inflammation (1932)

Event Type  Injury  

Event Description

An abstract from the publication, haijima n, et al ¿ ¿giant anastomotic aneurysm associated with albumin/glutaraldehyde sealant as a late complication after acute aortic dissection surgery: report of a case¿ stating, "a 74-year-old woman was taken to our hospital with a chief complaint of chest and back pain.She was diagnosed with stanford type a acute aortic dissection and underwent ascending aortic replacement.Fifteen months after surgery, a giant anastomotic aneurysm was found at the proximal and distal anastomoses on chest computed tomography (ct), and reoperation was indicated.Following sternal re-entry, anastomotic dehiscence was found where bioglue, albumin/glutaraldehyde sealant, had been applied during the previous surgery, and caused aneurysm.Severe postoperative adhesion precluded extensive surgery, and redo replacement of the ascending aorta was carried out.Histopathological examination revealed extensive necrosis of smooth muscle cells in the aortic wall at the anastomotic site and a marked inflammatory cell infiltration around the aortic wall and the artificial graft, and association of bioglue use was suggested.The use of appropriate tissue adhesives to reinforce the dissected aortic wall is important, as well as careful long-term follow-up.".

Manufacturer Narrative

This investigation is currently ongoing.Any additional information will be provided in the follow-up report.This report is being submitted as required by federal regulations and does not constitute an admission that the device caused or contributed to the reported event.Furthermore, this report reflects the event as alleged by the complainant and does not imply that the information reported to artivion is accurate or has been confirmed by artivion.

Event Description

The following questions were answered: 1.Lot number of bioglue used.Unknown.We only obtained the information that this surgery was performed 3 years ago.2.Amount of bioglue applied per site.Small amount.Bg was used in the false lumen and the anastomosis site.3.Was the bioglue used as an adjunct to sutures? if so, please provide details about the suturing technique.Please see the image.4.Is the surgeon a frequent user of bioglue? yes, the surgeon has used bg 100 times or more.

Manufacturer Narrative

The manufacturing records could not be reviewed as no lot numbers were provided and the exact surgery dates are unknown.Foreign body reactions have been reported with the use of bioglue.Hewitt et al.Performed an animal study where bioglue was applied to a sheep¿s aorta; histopathologically, bioglue generates only a minimal inflammatory response (hewitt et al.2001).When used properly, histopathological observations with bioglue are consistent with a normal foreign body reaction.Coselli et al.Found 2.6% of bioglue patients developed inflammatory, immune systemic allergic reaction (coselli et al.2003).The instructions for use list inflammatory and immune response as possible adverse incidents.The bioglue risk management file was reviewed.The reported events are addressed.No samples were returned.Based on the available information provided in the report, we are unable to definitively determine the cause of the events observed.Inflammatory response related to the use of bioglue cannot be excluded in relation to the reported event.Allergic reaction, inflammatory and immune response to bioglue are known possible complications and adequate precautions and warning are present in the ifu.Based on the information available, we are unable to determine the root cause of the events described by the surgeon.Bioglue has been used for over 20 years with all types of sutures with no confirmed reports of suture erosion caused by bioglue.This event does not identify additional hazards or modify the probability and severity of existing hazards.There is no indication that an error or deficiency occurred at artivion- formerly cryolife/jotec and the ifu adequately communicates risk.This report is being submitted as required by federal regulations and does not constitute an admission that the device caused or contributed to the reported event.Furthermore, this report reflects the event as alleged by the complainant and does not imply that the information reported to artivion is accurate or has been confirmed by artivion.

• Brand Name: BIOGLUE SYRINGE 5-PACK, 10 ML, JAPAN
• Type of Device: GLUE,SURGICAL,ARTERIES
• Manufacturer (Section D): ARTIVION, INC.; 1655 roberts blvd. nw; kennesaw GA 30144
• Manufacturer (Section G): ARTIVION, INC.; 1655 roberts blvd. nw; kennesaw GA 30144
• Manufacturer Contact: rochelle maney ; 1655 roberts blvd. nw; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 15962023
• MDR Text Key: 305327402
• Report Number: 1063481-2022-00025
• 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: 02/14/2023

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: Lay User/Patient
• Device Model Number: BG3510-5-J
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/16/2022
• Initial Date FDA Received: 12/12/2022
• Supplement Dates Manufacturer Received: 11/16/2022
• Supplement Dates FDA Received: 02/14/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 74 YR
• Patient Sex: Female