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

Model Number BG UNK

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

Patient Problem Anaphylactic Shock (1703)

Event Type  Injury  

Event Description

According to the initial report received, patient experienced anaphylactic shock following bioglue use.

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 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.Additional information was provided from the user facility.The procedure was an elective aortic aneurysm with aortic valve repair.This was in 2020.Looking at the notes the operation appears to have been progressing as expected until the application of a biological glue to establish haemostasis around the aorta.There appears to have been a period of profound hypotension/reduced mean arterial pressure prior to attempting to wean from cardiopulmonary bypass.It was also difficult to wean from bypass.According to the notes the myocardial function looked reasonable and increased inotropes and vasopressors were needed to maintain the blood pressure.Some angioedema/swelling had developed and a mast cell tryptase was significantly raised at 70ng/ml (0-11ng/ml normal range).The patient remained ventilated on icu until everything was settled.The patient has been seen several times by the immunology team and the following tests performed: skin prick tests: bioglue negative, bovine gelatin negative; blood tests: specific ige to horse and cow negative (he has allergic rhinitis to horses); fel d 2 - low positive (1.46) ¿ (cat serum albumin).Other relevant investigations include: ckit variant not detected and normal baseline mct (making a mast cell disorder less likely); awaiting results of alpha tryptase gene testing.He has been successfully challenged to flucloxacillin (a dose of which was given during bypass).The immunologists concluded that although the cause of the reaction was still uncertain, the glue was temporally most closely associated with it, and they had excluded some alternative causes.The quantity of bioglue used was unknown.Previous exposure to bioglue was unknown.The patient has made a good recovery.Based on the information provided, insufficient evidence is provided to determine what caused the anaphylactic reaction; however, a potential 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 reaction to bioglue cannot be excluded.A review of the 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 for investigation 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 reaction to bioglue cannot be excluded.A review of the 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
• 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: 19116027
• MDR Text Key: 340275505
• Report Number: 1063481-2024-00006
• 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: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/16/2024

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: BG UNK
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/22/2024
• Initial Date FDA Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: No
• 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