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

Model Number BG UNKNOWN

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

Patient Problem Discharge (2225)

Event Date 10/02/2019

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, "yesterday, i had a meeting with one of the neurosurgeon in the mena region, and he stopped using bioglue, the reason is that he faced some post-operative complications (neurological discharge in 3-4 cases).".

Manufacturer Narrative

The manufacturing records could not be reviewed as a lot number nor a date of surgery was provided.Neither the quanitity of bioglue applied nor the surgical application (i.E., as an adjunct to the sututre, in conjunction with a dural patch material, etc.) are known.Additionally, the surgeon does not describe the nature of the discharge.A foreign body type inflammatory response to bioglue cannot be excluded.In the absence of additional information, it is not possible to definitively determine the cause of the events observed in the patient.There is no statement restricting the use of bioglue for general neurological procedures in canada.Per the ifu (instructions for use), bioglue is contraindicated for use in the cerebrovascular repairs and any intra-luminal areas.There is also the following statement in the ifu, ¿due to clinical reports of ineffective sealing when bioglue is used in the translabyrinthine approach for acoustic neuroma repairs, its use with this surgical approach is not recommended¿.There is insufficient information available to determine a root cause for the reported events.Foreign body inflammatory reactions to bioglue are known to occur and is listed as a potential complication in the 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.

Event Description

According to the initial report, "yesterday, i had a meeting with one of the neurosurgeon in the mena region, and he stopped using bioglue, the reason is that he faced some post-operative complications (neurological discharge in 3-4 cases),".

• Brand Name: BIOGLUE - UNKNOWN CONFIGURATION
• Type of Device: GLUE,SURGICAL,ARTERIES
• Manufacturer (Section D): CRYOLIFE, INC.; 1655 roberts blvd., nw; kennesaw GA 30144
• MDR Report Key: 9145005
• MDR Text Key: 162316781
• Report Number: 1063481-2019-00053
• 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
• Type of Report: Initial,Followup
• Report Date: 11/07/2019

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: Health Professional
• Device Model Number: BG UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 09/02/2019
• Initial Date Manufacturer Received: 09/02/2019
• Initial Date FDA Received: 10/02/2019
• Supplement Dates Manufacturer Received: 09/02/2019
• Supplement Dates FDA Received: 11/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other