MAUDE Adverse Event Report: ARTIVION, INC. BIOGLUE SYRINGE 5-PACK, 5ML, G; GLUE, SURGICAL, ARTERIES

Model Number BG3515-5-G

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

Patient Problem Anaphylactic Shock (1703)

Event Date 04/10/2023

Event Type  Injury  

Event Description

According to the manufacturer incident report (mir) received, "the device (bioglue surgical adhesive) was used as indicated, in this case to reinforce the suture line in the aorta following an aortic valve replacement.When the aortic cross clamp came off, the patient developed serious anaphylaxis which evolved gradually and required ongoing treatment with adrenalin, which went on for several hours post cardiopulmonary bypass.A tryptase rise confirmed the clinical impression of anaphylaxis.Allergy was confirmed on subsequent testing".

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 artivion is accurate or has been confirmed by artivion.

Manufacturer Narrative

A sample evaluation was not performed as no product was explanted or returned.The manufacturing records for 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.Based on the information provided, insufficient evidence is provided to definitively determine what caused the anaphylactic reaction.Additional information shows that the patient has pork-cat syndrome which results in a reaction to non-bovine albumin (cat with cross reactivity to pork).However, a potential cross reactivity reaction to bioglue cannot be excluded.The following is provided in the applicable bioglue instructions for use: ¿bioglue is not for patients with known sensitivity to materials of bovine origin." additionally, the following warning is provided within the ifu: "exercise caution with repeat exposure of bioglue in the same patient.Hypersensitivity reactions are possible upon exposure to bioglue.Sensitization has been observed in animals." the root cause of the observed event is unknown.However, a potential cross reactivity reaction to bioglue cannot be excluded.A review of ifu shows adequate precautions and warnings provided about the potential for allergic reaction.The bioglue surgical adhesive risk file was reviewed.The reported events are addressed in the a/dfmea.No samples were returned and a device history record (dhr) review was performed.No issues were found related to the reported lot number.The root cause of the observed event is unknown.However, a potential cross reactivity reaction to bioglue cannot be excluded.A review of ifu shows adequate precautions and warnings provided about the potential for allergic reaction.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 low 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 SYRINGE 5-PACK, 5ML, G
• Type of Device: GLUE, SURGICAL, ARTERIES
• Manufacturer (Section D): ARTIVION, 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: 18893227
• MDR Text Key: 337520626
• Report Number: 1063481-2024-00004
• Device Sequence Number: 1
• Product Code: MUQ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P010003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/26/2024

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: BG3515-5-G
• Device Lot Number: BG000908
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/21/2024
• Initial Date FDA Received: 03/13/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/18/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 74 YR
• Patient Sex: Male