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

Model Number BG3510-5-J

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

Patient Problem Inflammation (1932)

Event Type  Injury  

Manufacturer Narrative

This investigation is currently ongoing.Any additional information will be provided in the follow-up report.

Event Description

Inflammatory reaction (creation of thick constructs, reportedly "tissue") has been reported at the sites where bioglue was previously applied.No intervention has been required yet, and this inflammatory reaction and creation of 'tissue' were confirmed based on the ct scan.The surgeon later admitted there was some inappropriate use of the device and noted this probably led to the reported incident.Bioglue was applied to both proximal and distal suture lines, during the placement of the hemi arch.The surgeon repeatedly applied bioglue to the same sites and tissue around the suture lines until one syringe was used up.

Event Description

Inflammatory reaction (creation of thick constructs, reportedly "tissue") has been reported at the sites where bioglue was previously applied.No intervention has been required yet, and this inflammatory reaction and creation of 'tissue' were confirmed based on the ct scan.The surgeon later admitted there was some inappropriate use of the device and noted this probably led to the reported incident.Bioglue was applied to both proximal and distal suture lines, during the placement of the hemi arch.The surgeon repeatedly applied bioglue to the same sites and tissue around the suture lines until one syringe was used up.A lot number was not provided by the distributor.

Manufacturer Narrative

A review of the available information was performed.According to the report, bioglue was applied to the proximal and distal suture lines during a hemiarch replacement procedure.An inflammatory reaction (creation of thick constructs, reportedly "tissue") was observed at the sites where bioglue was previously applied.No intervention has been required yet, and this inflammatory reaction and creation of tissue were confirmed based on the ct scan.The ¿surgeon later admitted there was some inappropriate use of the device for this case as well and commented this probably led to the reported incident.He also said the amount of tissue created seemed to be way more in amount to believe bioglue was simply denatured¿."excessive amount of bg [bioglue] was used; after applied to both proximal and distal suture lines, surgeon repeatedly applied bg to the same sites and tissue around the suture lines until one syringe was used up." the following is unknown: how much bioglue was used during the procedure, how much time passed before the inflammatory reaction was observed, and if any other materials/surgical glues were used.In the bioglue ifu it warns ¿bioglue should be applied in a thin layer as an adjunct to sutures or staples, and in amounts sufficient to seal the area.Bioglue should not be applied in excess.¿ inflammatory reaction is listed as an observed and potential adverse event in the ifu as well.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 generate 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 2003).The exact amount of bioglue used is unknown; however, the surgeon states ¿there was some inappropriate use of the device for this case¿.If a large amount was utilized it could result in an enhanced or prolonged inflammatory reaction.The root cause of the observed events is due to the excessive application of bioglue as stated by the surgeon.Secondary inflammation and fibrosis may have also been contributing factors.Inflammatory reactions to bioglue are known to occur and adequate precautions and warning are present in the ifu.All risks identified have been mitigated as far as possible by design and process and residual risk is acceptable.No further action recommended.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 cryolife is accurate or has been confirmed by cryolife.

• Brand Name: BIOGLUE SYRINGE 5-PACK, 10ML
• Type of Device: GLUE,SURGICAL,ARTERIES
• Manufacturer (Section D): CRYOLIFE, INC.; 1655 roberts blvd. nw; kennesaw GA 30144
• MDR Report Key: 8754916
• MDR Text Key: 149844483
• Report Number: 1063481-2019-00038
• Device Sequence Number: 1
• Product Code: MUQ
• Combination Product (y/n): N
• PMA/PMN Number: P010003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 08/26/2019

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
• Distributor Facility Aware Date: 06/07/2019
• Initial Date Manufacturer Received: 06/07/2019
• Initial Date FDA Received: 07/02/2019
• Supplement Dates Manufacturer Received: 06/07/2019
• Supplement Dates FDA Received: 08/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other