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

Model Number BG UNK

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

Patient Problems Coma (2417); Embolism/Embolus (4438)

Event Type  Injury  

Event Description

According to the article, ¿cerebral embolic shower secondary to bioglue use in triple valve surgery¿ rajan vka, et al., a 49-year-old lady, with rheumatoid arthritis and type 2 diabetes mellitus, was diagnosed with rheumatic heart disease, severe mitral regurgitation, moderate aortic regurgitation, moderate tricuspid regurgitation, and a left ventricular ejection fraction of 40%.She was in atrial fibrillation with no intracardiac thrombus.She underwent aortic valve replacement and following aortic cross-clamp release, there was bleeding from the aortic suture line posteriorly which could not be controlled with pledgetted polypropylene sutures from outside.The posterior tear was probably due to extension of the aortotomy incision while placing the mechanical aortic valve.The aorta was re-clamped, aortotomy was opened, and the posterior tear was repaired from the inside of the aorta with continuous running 5-0 polypropylene sutures.The aortotomy was closed and the cross-clamp was released.There was minimal persistent bleeding from the posterior aorta.Bioglue was applied as a film over the posterior aortic suture line and the transverse sinus was packed with oxidized cellulose polymer.Bleeding was controlled successfully and the patient was weaned off cardiopulmonary bypass.The patient was unresponsive for 48 h.Magnetic resonance imaging (mri) with angiography (mra) of the brain revealed multiple punctate scattered foci of acute infarcts in the bilateral frontal lobe, parietal lobe, centrum semiovale, right occipital lobe, frontal periventricular region, bilateral caudate nuclei, left lentiform nucleus, left thalamus, and splenium of the corpus callosum suggestive of an embolic shower.Considering the infarct extent and her immediate postoperative status, she was not a candidate for neuro-intervention.A computed tomography (ct) of the brain repeated 72 h later revealed no interval increase in the infarct extent.She remained comatose and was tracheostomized on the seventh postoperative day.She regained consciousness on the fifteenth postoperative day.Repeat mri done a month later revealed no interval change.With intense neuro-rehabilitation and physiotherapy over the following 6 weeks, she progressed remarkably and was weaned off the ventilator, and the tracheostomy was decannulated on the 59th postoperative day.She was discharged with no residual neurological deficits on the 61st postoperative day.She remained neurologically normal at her 6-month follow-up.

Manufacturer Narrative

Multiple attempts to obtain additional information were made with no response.The manufacturing records were not reviewed since the publication did not list a bioglue lot number or any dates of procedure.It is unknown the amount of bioglue used, and if any steps were taken to avoid leakage into the aorta.Bioglue embolization has been previously reported.Guidance related to prevention of bioglue embolism is provided in the product¿s instructions for use and include, but is not limited to, avoiding negative pressure during bioglue application to prevent bioglue from crossing through suture holes into the patient¿s cardiovascular system.Root cause of the reported event is unknown.However, guidance for prevention of bioglue embolism during application is provided in the product¿s instructions for use (ifu).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 article, ¿cerebral embolic shower secondary to bioglue use in triple valve surgery¿ rajan vka, et al., a 49-year-old lady, with rheumatoid arthritis and type 2 diabetes mellitus, was diagnosed with rheumatic heart disease, severe mitral regurgitation, moderate aortic regurgitation, moderate tricuspid regurgitation, and a left ventricular ejection fraction of 40%.She was in atrial fibrillation with no intracardiac thrombus.She underwent aortic valve replacement and following aortic cross-clamp release, there was bleeding from the aortic suture line posteriorly which could not be controlled with pledgetted polypropylene sutures from outside.The posterior tear was probably due to extension of the aortotomy incision while placing the mechanical aortic valve.The aorta was re-clamped, aortotomy was opened, and the posterior tear was repaired from the inside of the aorta with continuous running 5-0 polypropylene sutures.The aortotomy was closed and the cross-clamp was released.There was minimal persistent bleeding from the posterior aorta.Bioglue was applied as a film over the posterior aortic suture line and the transverse sinus was packed with oxidized cellulose polymer.Bleeding was controlled successfully and the patient was weaned off cardiopulmonary bypass.The patient was unresponsive for 48 h.Magnetic resonance imaging (mri) with angiography (mra) of the brain revealed multiple punctate scattered foci of acute infarcts in the bilateral frontal lobe, parietal lobe, centrum semiovale, right occipital lobe, frontal periventricular region, bilateral caudate nuclei, left lentiform nucleus, left thalamus, and splenium of the corpus callosum suggestive of an embolic shower.Considering the infarct extent and her immediate postoperative status, she was not a candidate for neuro-intervention.A computed tomography (ct) of the brain repeated 72 h later revealed no interval increase in the infarct extent.She remained comatose and was tracheostomized on the seventh postoperative day.She regained consciousness on the fifteenth postoperative day.Repeat mri done a month later revealed no interval change.With intense neuro-rehabilitation and physiotherapy over the following 6 weeks, she progressed remarkably and was weaned off the ventilator, and the tracheostomy was decannulated on the 59th postoperative day.She was discharged with no residual neurological deficits on the 61st postoperative day.She remained neurologically normal at her 6-month follow-up.

• Brand Name: BIOGLUE - UNKNOWN CONFIGURATION
• 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: 15250407
• MDR Text Key: 298143630
• Report Number: 1063481-2022-00015
• Device Sequence Number: 1
• Product Code: MUQ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P010003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/02/2022

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: BG UNK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/22/2022
• Initial Date Manufacturer Received: 07/22/2022
• Initial Date FDA Received: 08/18/2022
• Supplement Dates Manufacturer Received: 07/22/2022
• Supplement Dates FDA Received: 11/02/2022
• 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): Hospitalization; Life Threatening
• Patient Age: 49 YR
• Patient Sex: Female