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 Embolism/Embolus (4438)

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

Event Description

According to article, "in vivo optical coherence tomography visualization of coronary artery embolism caused by bioglue in a middle-aged woman with marfan syndrome who underwent the bentall procedure: a case report" yukihiro hamaguchi, soichiro enomoto, hirokazu kondo, toshihiro tamura."a 47-year-old woman underwent ascending aortic replacement and coronary artery bypass grafting (cabg) for type a acute aortic dissection involving the right coronary artery ostium in 2017.Subsequently, she was diagnosed with marfan syndrome.Five years later in 2022, she underwent aortic arch replacement, the bentall procedure, and repeat cabg because of aortic root enlargement and aortic regurgitation progression.Twelve days after surgery, coronary computed tomography angiography (ccta) revealed left anterior descending (lad) artery stenosis, whereas pre-operative ccta was normal.On post-operative day 13, coronary angiography revealed 99% lad artery stenosis.Intravascular ultrasound (ivus) showed a non-echoic mass with clear margins, and optical coherence tomography (oct) demonstrated a crystalloid mass.Both images suggested that the embolus was inorganic matter, suspected as being the surgical adhesive bioglue.We could not remove the embolus by repeated thrombectomy; therefore, drug-eluting stent implantation was performed.Seven months after surgery, she had no symptoms, and ccta confirmed stent patency.".

Manufacturer Narrative

According to article, "in vivo optical coherence tomography visuali[s]ation of coronary artery embolism caused by bioglue in a middle-aged woman with marfan syndrome who underwent the bentall procedure: a case report" yukihiro hamaguchi, soichiro enomoto, hirokazu kondo, toshihiro tamura."a 47-year-old woman underwent ascending aortic replacement and coronary artery bypass grafting (cabg) for type a acute aortic dissection involving the right coronary artery ostium in 2017.Subsequently, she was diagnosed with marfan syndrome.Five years later in 2022, she underwent aortic arch replacement, the bentall procedure, and repeat cabg because of aortic root enlargement and aortic regurgitation progression.Twelve days after surgery, coronary computed tomography angiography (ccta) revealed left anterior descending (lad) artery stenosis, whereas pre-operative ccta was normal.On post-operative day 13, coronary angiography revealed 99% lad artery stenosis.Intravascular ultrasound (ivus) showed a non-echoic mass with clear margins, and optical coherence tomography (oct) demonstrated a crystalloid mass.Both images suggested that the embolus was inorganic matter, suspected as being the surgical adhesive bioglue.We could not remove the embolus by repeated thrombectomy; therefore, drug-eluting stent implantation was performed.Seven months after surgery, she had no symptoms, and ccta confirmed stent patency." the lot number for this event is unknown.A review of manufacturing records could not be performed as a definitive lot number and date of surgery were not provided by the complainant.A review of the available information was performed.Per the manuscript, a thrombectomy was attempted 13 days postoperative and the ¿intravascular ultrasound (ivus) showed a non-echoic mass with clear margins, and optical coherence tomography (oct) demonstrated a crystalloid mass.Both images suggested that the embolus was inorganic matter, suspected as being the surgical adhesive bioglue, however the embolus could not be removed.Therefore, 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.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 and the suspected embolus was never collected and confirmed to be bioglue.Consequently, 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 thromboembolism is listed as a potential adverse event, this is not an unexpected event.This case does not show a new adverse event related to the use of bioglue.No actions are required at this time.Based on the available information, there is insufficient evidence to determine a definitive root cause and the suspected embolus was never collected and confirmed to be bioglue.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; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 18327953
• MDR Text Key: 330554289
• Report Number: 1063481-2023-00022
• 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: 02/07/2024

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: BG3510-5-J
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 12/07/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/14/2023
• Supplement Dates Manufacturer Received: 12/07/2023
• Supplement Dates FDA Received: 02/07/2024
• 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; Required Intervention
• Patient Age: 47 YR
• Patient Sex: Female