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

Model Number BG3510-5-US; BG3502-5-US

Device Problem Device Damaged by Another Device (2915)

Patient Problem Obstruction/Occlusion (2422)

Event Date 04/18/2022

Event Type  Injury  

Event Description

According to the initial report, an on-x valve was explanted 4-days post-op because bioglue impeded the function of the valve.

Manufacturer Narrative

Two potential lot numbers were identified for this event and are included in this investigation.The manufacturing records for bg3510-5-us, lot bg000507 and bg3502-5-us, lot bg000495 and 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 found to be related to the complaint.Bioglue was applied during the implantation of an on-x valve, to augment anastomosis of the ascending aorta and sinotubular junction.According to the sales representative, ¿bioglue leaked through the anastomosis and gummed up the leaflets, causing one to freeze closed.¿ per miyata, the most common causes of mechanical aortic valve dysfunction are pannus formation, entrapment of the leaflet by thrombus, vegetation, and subvalvular tissue.Pannus, thrombus and vegetation are unlikely to arise immediately after implantation of the aortic valve.According to the case report by miyata, the stuck leaflet was a rare case caused by residual suture materials.The bioglue ifu lists mitigation techniques that may limit the risk of adhesive leakage.The explanted valve was not available for examination and no testing was performed to determine if bioglue was present in or around the leaflet; therefore, there is insufficient evidence or information to determine the root cause.It was noted that gauze was placed to keep the bioglue from entering any unwanted areas, and the bioglue was allowed to polymerize for 2 minutes.But it is unknown if the other mitigation techniques described in the ifu, intended to prevent inadvertent leakage or spillage into unplanned anatomic sites, were followed.The amount of bioglue used in this case is also unknown.The bioglue a/dfmea was reviewed and the reported event is addressed.The occurrence rating based on the previous 18-months did not increase as a result of this event.The reported events will continue to be monitored for trends.No updates to the rmf are needed in response to this complaint.Risk has been reduced as far as possible and overall residual risk is acceptable.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 artivion- formerly cryolife/jotec is accurate or has been confirmed by artivion.

• Brand Name: BIOGLUE
• Type of Device: GLUE, SURGICAL, ARTERIES
• Manufacturer (Section D): CRYOLIFE, INC; 1655 roberts blvd. nw; kennesaw GA 30144
• Manufacturer (Section G): ARTIVION, INC.; 1655 roberts blvd. nw; kennesaw GA 30144
• Manufacturer Contact: rochelle maney ; 1655 roberts blvd. nw; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 15052727
• MDR Text Key: 296142705
• Report Number: 1063481-2022-00012
• Device Sequence Number: 1
• Product Code: MUQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P01003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/08/2022

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 Model Number: BG3510-5-US; BG3502-5-US
• Device Lot Number: BG000507; BG000495
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/21/2022
• Initial Date FDA Received: 07/19/2022
• Supplement Dates Manufacturer Received: 06/21/2022
• Supplement Dates FDA Received: 09/08/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR
• Patient Sex: Female