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

Model Number BG3510-5-G

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

Patient Problem Reaction (2414)

Event Date 09/29/2020

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, (b)(6)-year-old male underwent replacement of his aortic root/ascending aorta and pulmonary vein isolation.After 3 hours on crossclamp bioglue was applied to the aortic graft anastomosis and he suffered an anaphylactic shock within 10 minutes.This took time to reverse and extended his operating time and hospital stay.He is now recovered and discharged.This complaint is in reference to bg3510-5-g, lot 19egx006.

Manufacturer Narrative

The manufacturing records for bg3510-5-g lot 19egx006 were reviewed and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.All lots passed functional testing and met release specifications.During the investigation no non-conformances or deviations were noted that could have been related to the complaint.A clinical researcher and medical director reviewed the available information.It is unknown if bioglue had been used on the patient in a prior procedure, and whether there was a known pre-existing bovine allergy.The described clinical symptoms are consistent with an anaphylactic reaction.Based on the information provided, a potential anaphylactic reaction to bioglue cannot be ruled out.Inflammation and immune response as well as allergic reaction are listed as possible adverse events in the instructions for use (ifu).The root cause of the observed event is unknown.However, an allergic reaction to bioglue cannot be excluded.The bioglue a/dfmea was reviewed and the reported event was found to be addressed.The reported event could not be confirmed.No sample was returned and review of the dhr did not indicate any issues that could have contributed to the reported event.Potential causes of the event are use in a contaminated area or improper aseptic technique.No new risks were identified during the course of the risk management departmental complaint investigation.All risks identified have been mitigated as far as possible and residual risk is acceptable.This complaint was reviewed for a capa evaluation.The root cause of the observed event is unknown.However, an allergic reaction to bioglue cannot be excluded.Other potential causes of the event could be use in a contaminated area or improper aseptic technique.This event does not identify additional hazards or modify the probability and severity of existing hazards.There is no indication that an error or deficiency occurred at cryolife and the ifu adequately communicates risk; therefore, a capa evaluation by the capa department is not warranted at this time.Field assurance will continue to monitor similar complaints to determine if additional actions are warranted; however, at this time no further actions are necessary.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
• Type of Device: GLUE, SURGICAL, ARTERIES
• Manufacturer (Section D): CRYOLIFE, INC.; 1655 roberts blvd. nw; kennesaw GA 30144
• MDR Report Key: 10733854
• MDR Text Key: 213010175
• Report Number: 1063481-2020-00027
• Device Sequence Number: 1
• Product Code: MUQ
• Combination Product (y/n): N
• PMA/PMN Number: P01003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/11/2020

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: No Information
• Device Model Number: BG3510-5-G
• Device Lot Number: 19EGX006
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/02/2020
• Initial Date FDA Received: 10/26/2020
• Supplement Dates Manufacturer Received: 10/02/2020
• Supplement Dates FDA Received: 12/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR