MAUDE Adverse Event Report: ARTIVION, INC. BIOGLUE SYRINGE 5-PACK, 10 ML, JAPAN; GLUE,SURGICAL,ARTERIES

Model Number BG3510-5-J

Device Problem Material Fragmentation (1261)

Patient Problem Thromboembolism (2654)

Event Type  Injury  

Event Description

According to article, "left main coronary artery embolism caused by bioglue surgical adhesive after type a acute aortic dissection repair: intracoronary imaging and histopathological analysis" keisuke yamamoto, kensaku nishihira, yujiro asada, and yoshisato shibata, "a 78-year-old woman with hypertension was hospitalized for type a acute aortic dissection (panel a, arrows).During emergency surgery, the ascending aorta was replaced with a prosthetic graft after injection of bioglue surgical adhesive into the false lumen to reinforce the anastomotic sites (panel b).Five days after surgery, she developed acute coronary syndrome.Circulation was stabilized after veno-arterial extracorporeal membrane oxygenation.Urgent coronary angiography identified subtotal occlusion of the left main coronary artery (lmca) (panel c, arrowhead; supplementary material online, video s1).Our heart team decided to perform percutaneous coronary intervention.Thrombectomy was repeatedly attempted with an aspiration catheter, but only a tiny amount of material was aspirated.Intravascular ultrasound (ivus) imaging showed a bright structure protruding into the lumen and a posterior acoustic shadow (panel d), without atherosclerosis nearby.On optical coherence tomography (oct) imaging, the structure had irregular margins and posterior signal attenuation (panel e).Although the lesion was dilated with a balloon, the angiographic appearance remained unchanged, so we decided to cover it with a stent.A drug-eluting stent was successfully implanted in the lmca, resulting in an angiographically complete resolution of the filling defect (see supplementary material online, video s2).Histopathological examination revealed that the aspirated materials consisted of thrombus and many bioglue fragments without atherosclerotic components (panel f, arrows).This is the first report showing lmca embolism caused by bioglue surgical adhesive detected with both ivus and oct and histopathological confirmation.This potentially fatal complication might occur after type a acute aortic dissection repair.".

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 ¿ formerly cryolife/jotec is accurate or has been confirmed by artivion ¿ formerly cryolife/jotec.

Manufacturer Narrative

According to article, "left main coronary artery embolism caused by bioglue surgical adhesive after type a acute aortic dissection repair: intracoronary imaging and histopathological analysis" keisuke yamamoto, kensaku nishihira, yujiro asada, and yoshisato shibata, "a 78-year-old woman with hypertension was hospitalized for type a acute aortic dissection (panel a, arrows).During emergency surgery, the ascending aorta was replaced with a prosthetic graft after injection of bioglue surgical adhesive into the false lumen to reinforce the anastomotic sites (panel b).Five days after surgery, she developed acute coronary syndrome.Circulation was stabilized after veno-arterial extracorporeal membrane oxygenation.Urgent coronary angiography identified subtotal occlusion of the left main coronary artery (lmca) (panel c, arrowhead; supplementary material online, video s1).Our heart team decided to perform percutaneous coronary intervention.Thrombectomy was repeatedly attempted with an aspiration catheter, but only a tiny amount of material was aspirated.Intravascular ultrasound (ivus) imaging showed a bright structure protruding into the lumen and a posterior acoustic shadow (panel d), without atherosclerosis nearby.On optical coherence tomography (oct) imaging, the structure had irregular margins and posterior signal attenuation (panel e).Although the lesion was dilated with a balloon, the angiographic appearance remained unchanged, so we decided to cover it with a stent.A drug-eluting stent was successfully implanted in the lmca, resulting in an angiographically complete resolution of the filling defect (see supplementary material online, video s2).Histopathological examination revealed that the aspirated materials consisted of thrombus and many bioglue fragments without atherosclerotic components (panel f, arrows).This is the first report showing lmca embolism caused by bioglue surgical adhesive detected with both ivus and oct and histopathological confirmation.This potentially fatal complication might occur after type a acute aortic dissection repair." no lot number referenced.The following information was received in response to a request for additional information: current patient status? alive.Lot number? unknown.Date of procedure? on (b)(6) 2022.Amount of bg applied? about 1 ml total.Was the target field dry at the time of application? yes.Were other materials used for reinforcement? if yes, specify which materials and where they were used.No.Was bioglue used as an adjunct to sutures? if yes, please provide details about suturing technique.No.Was the vessel or graft clamped and depressurized prior to application of bioglue? yes.Was bioglue used in a contaminated or infected area? no.Please describe the condition/integrity of the native tissue where bioglue was applied: atherosclerosis, calcification, friable, inflammation, or other? only changes in aortic dissection.No other findings.Was the bioglue syringe primed and de-aired? yes.Are any pieces of the explanted material available for return to the manufacturer? no the lot number was provided by the distributor.This investigation will be relegated to bg3510-5-j lot number: bg000503.The manufacturing records for bg3510-5-j, lot number: bg000503 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.A review of the available information was performed.Per the manuscript, a thrombectomy was performed 5 days postoperative and the ¿histopathological examination revealed that the aspirated materials consisted of thrombus and many bioglue fragments without atherosclerotic components¿, however no sample was returned to artivion for evaluation and there is no pathology report available for review.In addition, no surgical reports or medical records are available.Additional information was provided after request, but we have no way to evaluate if the product bioglue was applied per the ifu which covers the proper application of the product with specific instruction for use in aortic dissection surgery.Additionally, thromboembolism is listed as a potential adverse event and, therefore, is not an unexpected event.Embolization of surgical adhesives has been reported in the literature (1,2) and can occur with native tissue as well as prosthetic conduits.Lemaire reported that adhesives can enter vessels and grafts through needle holes even when applied properly.The use of histology to confirm the presence of bioglue as was also reported in this case report.Le maire also addresses mitigation techniques that may limit the risk of adhesive leakage, these match the precautions outlined in the instructions for use (ifu).Two mitigation techniques mentioned are 1) pressurizing the anastomoses before applying the glue and 2) applying the glue after achieving hemostasis as the glue does not adhere to tissue in the setting of active bleeding.For this specific event there is insufficient evidence to determine a definitive root cause as no sample was returned to artivion for evaluation and no pathology or medical records were available for review.It is also unknown if all of the mitigation techniques disclosed in lemaire and the ifu were followed.However, embolization of surgical adhesives has been reported in the literature.As both thromboembolism and occlusion/thrombosis are listed as potential adverse events they are not unexpected events.This case does not show a new adverse event related to the use of bioglue.No action required.A complaint and recall query was performed for bg3510-5-j, lot number: bg000503 to identify previously reported complaints or recalls associated with this lot number.No complaints or recalls were identified for this lot number.Based on the available information, a definitive root cause for this event cannot be determined.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.This event does not identify additional hazards or modify the probability and severity of existing hazards.There is no indication that an error or deficiency occurred at artivion ¿ formerly cryolife/jotec and the ifu adequately communicates risk.This complaint was reviewed for a capa evaluation and a capa is not warranted at this time.Artivion will continue to monitor similar complaints to determine if additional actions are warranted; however, at this time no further actions are necessary.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 ¿ formerly cryolife/jotec.

• Brand Name: BIOGLUE SYRINGE 5-PACK, 10 ML, JAPAN
• 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: 17544012
• MDR Text Key: 321103049
• Report Number: 1063481-2023-00016
• Device Sequence Number: 1
• Product Code: MUQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P010003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/27/2023

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: 08/05/2023
• Device Model Number: BG3510-5-J
• Device Lot Number: BG000503
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/07/2023
• Initial Date FDA Received: 08/14/2023
• Supplement Dates Manufacturer Received: 08/07/2023
• Supplement Dates FDA Received: 10/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female