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

Model Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Meningitis (2389)

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 uses bioglue for expanded endonasal skull base procedures - pituitary, encephalocele repair, meningioma.Bioglue was used directly on dura after duraplasty in the posterior fossa; it caused a severe prolonged chemical meningitis.

Manufacturer Narrative

Additional information received indicates that the patient recovered from the meningitis; no long term consequences of the bioglue use; surgery in 2015.A re-do surgery was performed to remove bioglue and supportive care provided.It was also reported that the surgeon has used and will continue to use bioglue for her transphenoidal procedures, the patient in question made a good recovery with no ill effects from the use of the glue.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 uses bioglue for expanded endonasal skull base procedures - pituitary, encephalocele repair, meningioma.Bioglue was used directly on dura after duraplasty in the posterior fossa, it caused a severe prolonged chemical meningitis.

Event Description

According to the initial report, "the surgeon uses bioglue for expanded endonasal skull base procedures - pituitary, encephalocele repair, meningioma.Bioglue was used directly on dura after duraplasty in the posterior fossa, it caused a severe prolonged chemical meningitis.

Manufacturer Narrative

Based on the information available at the time of this report, we are unable to definitively determine the root cause of the chemical meningitis observed in this patient or if bioglue, the patch material, and/or suture contributed to the observed event.It is possible that the surgeon used the bioglue alone, rather than as an adjunct to sutures, which could result in application of bioglue into unintended areas such as intradurally.Intradural bioglue could potentially cause an inflammatory reaction exhibited as chemical meningitis.There is no indication that an error or deficiency occurred at cryolife.The risk management file thoroughly identifies the process and product hazards for approved indications.Each individual hazard is mitigated and reduced as low as possible by design and process.The ifu (instructions for use) indicates the following potential adverse events may occur with the use of bioglue: inflammatory, immune systemic allergic reaction.This event does not identify additional hazards or modify the probability and severity of existing hazards.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 SURGICAL ADHESIVE
• Type of Device: GLUE, SURGICAL, ARTERIES
• Manufacturer (Section D): CRYOLIFE, INC.; 1655 roberts blvd., nw; kennesaw GA 30144
• MDR Report Key: 8212213
• MDR Text Key: 131912720
• Report Number: 1063481-2019-00001
• 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,Followup
• Report Date: 03/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/05/2018
• Date Manufacturer Received: 12/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other