MAUDE Adverse Event Report: CRYOLIFE, INC. BIOGLUE SURGICAL ADHESIVE; GLUE, SURGICAL, ARTERIES

Model Number BG3502-5-G

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the initial report, another case occurred by similar this mass effect has popped up and [the surgeon] reviewed this patient who had neuro surgery of spinal tumor at lumbar spine before.According to the report the operating surgeon relays that this patient had a decompressive laminotomy for spinal stenosis where bioglue was used.The bioglue was applied to the dura after suturing.The area was dry when the bioglue was applied.It was then discovered that the bioglue had formed a mass.The patient still had persistent leg pain after the decompression.

Manufacturer Narrative

This is the second case reported by this surgeon regarding a mass forming after the use of bioglue at the dura suture site to prevent csf leak after surgery.This case reports persistent left pain after decompression.The following information is unknown: how much bioglue was used, how it was applied (drops, thin layer, etc.), information surrounding the circumstances of the bioglue application (priming, etc.), and how much time had passed before the mass was discovered.There is no photo of the mass for this case, nor information regarding how the surgeon determined that it contained bioglue.In the 2014 journal article written by miscusi et al regarding bioglue being used to reinforce a dural repair site, the authors state "it is essential that a very thin layer of bioglue is applied; the application of larger quantities may create a pooling of glue, potentially leading to serious side effects, such as compression of the spinal cord and nerve roots (woo ej 2012)".The authors also conclude, "in all our patients, in both cranial and spinal surgery, we have never experienced complications directly related to its use".They found bioglue to be effective in intraoperative dural tears repair without resulting complications (miscusi et al 2014).Based on the available information, a definitive cause cannot be determined.Additionally, it is unknown how the bioglue was applied and if a thin layer was used.The pooling of bioglue creating a mass lesion resulting in neuro compression remains a possibility.The instructions for use warning states that "polymerized bioglue has occupying properties.When used improperly, or applied incorrectly, serious adverse events have been reported relating to compression of adjacent anatomic structures".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.

Event Description

According to the initial report, another case occurred by similar this mass effect has popped up and [the surgeon] reviewed this patient who had neuro surgery of spinal tumor at lumbar spine before.According to the report the operating surgeon relays that this patient had a decompressive laminotomy for spinal stenosis where bioglue was used.The bioglue was applied to the dura after suturing.The area was dry when the bioglue was applied.It was then discovered that the bioglue had formed a mass.The patient still had persistent leg pain after the decompression.

• Brand Name: BIOGLUE SURGICAL ADHESIVE
• Type of Device: GLUE, SURGICAL, ARTERIES
• Manufacturer (Section D): CRYOLIFE, INC.; 1655 roberts blvd nw; kennesaw GA 30144
• MDR Report Key: 8429762
• MDR Text Key: 139111034
• Report Number: 1063481-2019-00011
• 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: consumer,foreign,user facilit
• Type of Report: Initial,Followup
• Report Date: 06/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: BG3502-5-G
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other