MAUDE Adverse Event Report: CRYOLIFE, INC. BIOGLUE - UNKNOWN CONFIGURATION; GLUE, SURGICAL, ARTERIES

Model Number BG UNK

Device Problems Leak/Splash (1354); Off-Label Use (1494)

Patient Problems Cerebrospinal Fluid Leakage (1772); Unspecified Infection (1930); Neurological Deficit/Dysfunction (1982); Blood Loss (2597)

Event Type  Injury  

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 cryolife is accurate or has been confirmed by cryolife.

Event Description

Journal article: wang, w et al.Third ventricle floor bowing: a useful measurement to predict endoscopic third ventriculostomy success in infantile hydrocephalus." acta neurochirugica (2019): epub.A study where 42 hydrocephalic infants with third ventricle floor bowing were treated endoscopically between jan 2013 and apr 2018.To avoid postoperative csf leak and subdural collections, corticle hole was blocked with absorbable gelatin sponge and bioglue.While the article does not conclude that the posteropative complications from the study were attributed to bioglue, the following complications included seizure (2.4%), csf leak (2.4%), and subdural effusion (2.4%).Post operative complications: hemorrhage, infection, csf leak, and new neurological deficit.

Event Description

Journal article: wang, w et al.Third ventricle floor bowing: a useful measurement to predict endoscopic third ventriculostomy success in infantile hydrocephalus." acta neurochirugica (2019): epub.A study where 42 hydrocephalic infants with third ventricle floor bowing were treated endoscopically between jan 2013 and apr 2018.To avoid postoperative csf leak and subdural collections, corticale hole was blocked with absorbable gelatin sponge and bioglue.While the article does not conclude that the posteropative complications from the study were attributed to bioglue, the following complications included seizure (2.4%), csf leak (2.4%), and subdural effusion (2.4%).Post operative complications: hemorrhage, infection, csf leak, and new neurological deficit.

Manufacturer Narrative

Bioglue was used in conjunction with absorbable gelatin sponge to block the cortical hole.Bioglue is not indicated for this use.The ifu (instructions for use) states that bioglue is "indicated for use as an adjunct to standard methods of surgical repair (such as sutures, staples, electrocautery, and/or patches) to bond, seal, and/or reinforce soft tissue.There is insufficient information available to determine a root cause for the reported events.Bioglue is not indicated for the use described in the article.The risk analysis of the reported event has determined the event is adequately addressed in the risk file.There is insufficient information to determine if there is an association between the use of bioglue and the event reported.Each individual hazard is mitigated and reduced as low as possible by design and process.Post-production residual risk is communicated in the product's labeling and ifu.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 - UNKNOWN CONFIGURATION
• Type of Device: GLUE, SURGICAL, ARTERIES
• Manufacturer (Section D): CRYOLIFE, INC.; 1655 roberts blvd; kennesaw GA 30144
• MDR Report Key: 9601466
• MDR Text Key: 176843912
• Report Number: 1063481-2020-00080
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: BG UNK
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization