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

Model Number BG3502-5-G

Device Problem Insufficient Information (3190)

Patient Problems Weakness (2145); Reaction (2414)

Event Date 12/31/2018

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, [the surgeon] has done redo the patient, who had neuro surgery of spinal tumor at thoracic spine using bg 2ml for dural repair in last (b)(6), due to mass formation of bioglue.Additional information from the operating surgeon relays that on (b)(6) 2018 the patient had a meningioma (intradural extramedullary type) removed from the thoracic spine.The bioglue was applied after the dura was sutured with prolene.The area was dry where the bioglue was applied.The mass was located just over the dura mater.An mri (magnetic resonance imaging) was performed before surgery on (b)(6) 2019 to remove the bioglue mass.The bioglue mass was diagnosed about 3 months after the initial surgery.After the removal of the tumor, the patient felt leg weakness was improving.But the patient feels the leg weakness is becoming worse recently.

Manufacturer Narrative

The initial report states that 2ml of bioglue was used during the procedure, however it was not reported how it was applied.The material in the provided image is grossly consistent with polymerized bioglue admixed with blood.The concaved surface is consistent with application on a curved surface, such as, the dura overlying the spinal cord.In the 2004 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 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 resuting in complications (miscusi et al 2014).Based on the available information and photos provided, the gross appearance of the mass is consistent with bioglue admixed with blood.It is unknown how bioglue was applied, however the bioglue mass is suggestive of a large pooled quantity of bioglue.The neurological complications were likely a result of compression from the bioglue mass.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, [the surgeon] has done redo the patient, who had neuro surgery of spinal tumor at thoracic spine using bg 2ml for dural repair in last december, due to mass formation of bioglue.Additional information from the operating surgeon relays that on (b)(6) 2018 the patient had a meningioma (intradural extramedullary type) removed from the thoracic spine.The bioglue was applied after the dura was sutured with prolene.The area was dry where the bioglue was applied.The mass was located just over the dura mater.An mri (magnetic resonance imaging) was performed before surgery on (b)(6) 2019 to remove the bioglue mass.The bioglue mass was diagnosed about 3 months after the initial surgery.After the removal of the tumor, the patient felt leg weakness was improving.But the patient feels the leg weakness is becoming worse recently.

• 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: 8429746
• MDR Text Key: 139110273
• Report Number: 1063481-2019-00010
• 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: foreign,user facility
• 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): Hospitalization; Other; Required Intervention