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 Problems Anaphylactic Shock (1703); Urticaria (2278)

Event Date 08/17/2022

Event Type  Injury  

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.

Event Description

According to the manufacturer incident report (mir) received, "patient became vasoplegic on rewarming from cardiopulmonary bypass, after the aortic clamp was removed.This persisted despite incremental and high doses of vasoconstrictor drugs (noradrenalin and vasopressin) and ultimately only resolved when adrenalin was administered and then infused.A marked urticarial rash was noted on removing the drapes.Bioglue had been applied to the aortic suture line to seal the suture line prior to the clamp removal.This would be in line with the normal expectation and indications for use.This was the only new substance which had been introduced to the patient/bypass circuit/surgical field in over 2 hours.A tryptase rise to 54 ng/ml, settling to a normal baseline (7 ng/ml) 24 hours later confirms the clinical impression of anaphylaxis.Allergy investigation confirmed marked skin prick test positivity both to the pre-mixed bovine component and the post-mixed ( 'activated') component.Histamine release assay confirmed sensitisation to the premixed component.There was no evidence of alpha-gal or gelofusin or similar specific ige, however fel d2 (a cat allergen, positive in cat-pork syndrome) was positive.The patient reports significant cat allergy.".

Manufacturer Narrative

The manufacturing records for bg3515-5-g, lot bguk0530 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, the patient appears to have a bovine allergy.Additional information shows that the patient has cat-pork syndrome which results in a reaction to nonbovine 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.¿ hypersensitivity reactions are possible upon exposure to bioglue.Sensitization has been observed in animals.¿ the root cause of the observed event is not definitively known.However, a potential cross reactivity reaction to bioglue cannot be excluded.Furthermore, this patient has a known sensitization to bovine agents as shown in the skin prick test positivity.A review of the ifu shows adequate precautions and warnings provided about the potential for allergic reaction.No updates to the rmf (risk management file) 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 is accurate or has been confirmed by artivion.

Event Description

According to the manufacturer incident report (mir) received, "patient became vasoplegic on rewarming from cardiopulmonary bypass, after the aortic clamp was removed.This persisted despite incremental and high doses of vasoconstrictor drugs (noradrenalin and vasopressin) and ultimately only resolved when adrenalin was administered and then infused.A marked urticarial rash was noted on removing the drapes.Bioglue had been applied to the aortic suture line to seal the suture line prior to the clamp removal.This would be in line with the normal expectation and indications for use.This was the only new substance which had been introduced to the patient/bypass circuit/surgical field in over 2 hours.A tryptase rise to 54 ng/ml, settling to a normal baseline (7 ng/ml) 24 hours later confirms the clinical impression of anaphylaxis.Allergy investigation confirmed marked skin prick test positivity both to the pre-mixed bovine component and the post-mixed ( 'activated') component.Histamine release assay confirmed sensitisation to the premixed component.There was no evidence of alpha-gal or gelofusin or similar specific ige, however fel d2 (a cat allergen, positive in cat-pork syndrome) was positive.The patient reports significant cat allergy.".

• Brand Name: BIOGLUE SYRINGE 5-PACK, 5ML, G
• Type of Device: GLUE,SURGICAL,ARTERIES
• Manufacturer (Section D): ARTIVION, INC.; 1655 roberts boulevard nw; kennesaw GA 30144
• Manufacturer (Section G): ARTIVION, INC.; 1655 roberts boulevard nw; kennesaw GA 30144
• Manufacturer Contact: rochelle maney ; 1655 roberts boulevard nw; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 18789308
• MDR Text Key: 336344199
• Report Number: 1063481-2024-00003
• 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: 05/03/2024

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 Expiration Date: 08/19/2023
• Device Model Number: BG3515-5-G
• Device Lot Number: BGUK0530
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/31/2024
• Initial Date FDA Received: 02/27/2024
• Supplement Dates Manufacturer Received: 01/31/2024
• Supplement Dates FDA Received: 05/03/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/19/2022
• 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: 20 YR
• Patient Sex: Male