MAUDE Adverse Event Report: CRYOLIFE, INC. ¿ KENNESAW BIOGLUE SURGICAL ADHESIVE; GLUE,SURGICAL,ARTERIES

Model Number BG3510-5-J

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Stroke/CVA (1770); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This investigation is currently ongoing.Any additional information will be provided in the follow-up report.

Event Description

According to paper: unexpected intraoperative coronary malperfusion after primary repair of acute type a aortic dissection with surgical glue: during aortic root replacement for acute type a aortic dissection bioglue was placed in the false lumen.After removal of aortic cross-clamp, the wall motion of the entire left ventricle was severely deteriorated due to suspected impaired coronary blood flow.A cabg was performed.The authors assumed the narrowing was due to the dissection extending into the coronary artery."when the false lumen was fixed with glue in the absence of blood flow of the true lumen, the space in the false lumen can be stabilized and results in stenosis against the blood flow of the true lumen." additionally the following information could be found in the "comment" section of the paper."however, when the false lumen was fixed with glue in the absence of blood flow of the true lumen, the space in the false lumen can be stabilized and results in stenosis against the blood flow of the true lumen.Our method using the surgical glue for the aortic root replacement needs to be discussed.Neri et al.[1] recommend to first trim the dissected wall of the sinus of valsalva and then attach the dissected rim of the coronary button with glue.However, the dissected rim of the coronary button is usually difficult to handle.The present case may indicate the risk of secondary stenosis due to an inattentional use of the surgical glue.It may be important to secure the lumen of the coronary arteries before the surgical glue is used for fixating the dissected wall.The insertion of bougies into the coronary lumen may be recommended at the surgical glue fixation site.

Manufacturer Narrative

A review of the available information was performed.According to the journal article, "unexpected intraoperative coronary malperfusion after primary repair of acute type a aortic dissection with surgical glue" (kinoshita et al), during an aortic root replacement for acute type a aortic dissection bioglue was placed in the false lumen.After removal of aortic cross-clamp, the wall motion of the entire left ventricle was severely deteriorated due to suspected impaired coronary blood flow.A coronary artery bypass grafting (cabg) was performed.The authors assumed the narrowing was due to the dissection extending into the coronary artery.It was found that "when the false lumen was fixed with glue in the absence of blood flow of the true lumen, the space in the false lumen can be stabilized and results in stenosis against the blood flow of the true lumen (fig 2)." the authors state that their method of using surgical glue for aortic root replacement needed to be discussed.Trimming the dissected wall of the sinus valsalva and then attaching the dissected rim of the coronary button with glue has been recommended (neri et al 2001).The dissected rim of the coronary button is difficult to handle.They conclude that "the present case may indicate the risk of secondary stenosis due to an inattentional use of the surgical glue.It may be important to secure the lumen of the coronary arteries before the surgical glue is used for fixating the dissected wall.The insertion of bougies into the coronary lumen may be recommended at the surgical glue fixation site".Per the journal article, the surgeon did not realize that the dissection had extended into the coronary artery.Therefore, when placing bioglue into the false lumen an occlusion occurred in the true lumen of the coronary restricting blood flow, leading to a cabg and a drug-eluting stent placement in the left main trunk.The authors state that the "insertion of bougies into the coronary lumen may be recommended at the surgical glue fixation site".There are journal articles that recommend the placement of catheters in the coronary artery to protect it from obstruction.Bhamidipati et al states "similarly, a moist sponge can be used to protect the aortic valve leaflets and the coronary ostia when bioglue is being used to reconstruct a dissected aortic root.The left main coronary artery can also be protected by the gentle insertion of a red-rubber catheter to occlude the ostium".Raanani et al mentioned "it is essential to protect the ostia of the coronary arteries from accidental spillage of glue.This can be accomplished by inserting a fine flexible plastic cannula into the ostia before applying the glue".While the product ifu references using a catheter in the true lumen to keep the shape of the vessel for an aortic dissection procedure, it is not made clear to do the same for the coronary arteries: "the dissected layers of the aorta should be closely approximated by inserting a dilator, sponge, or catheter into the true lumen to preserve the natural architecture of the vessel".The most likely root cause of the reported event is unintentional application of bioglue into a false lumen tracking into a coronary artery.The instruction for use (ifu) does not currently address the hazard of unintentional application of bioglue into a coronary artery dissection.A quality plan was created to evaluate the adequacy of current bioglue information risk controls.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 cryolife is accurate or has been confirmed by cryolife.

Event Description

According to paper: unexpected intraoperative coronary malperfusion after primary repair of acute type a aortic dissection with surgical glue: during aortic root replacement for acute type a aortic dissection bioglue was placed in the false lumen.After removal of aortic cross-clamp, the wall motion of the entire left ventricle was severely deteriorated due to suspected impaired coronary blood flow.A cabg was performed.The authors assumed the narrowing was due to the dissection extending into the coronary artery."when the false lumen was fixed with glue in the absence of blood flow of the true lumen, the space in the false lumen can be stabilized and results in stenosis against the blood flow of the true lumen." see fig.2 in the paper additionally the following information could be found in the "comment" section of the paper."however, when the false lumen was fixed with glue in the absence of blood flow of the true lumen, the space in the false lumen can be stabilized and results in stenosis against the blood flow of the true lumen (fig.2).Our method using the surgical glue for the aortic root replacement needs to be discussed.Neri et al.[1] recommend to first trim the dissected wall of the sinus of valsalva and then attach the dissected rim of the coronary button with glue.However, the dissected rim of the coronary button is usually difficult to handle.The present case may indicate the risk of secondary stenosis due to an inattentional use of the surgical glue.It may be important to secure the lumen of the coronary arteries before the surgical glue is used for fixating the dissected wall.The insertion of bougies into the coronary lumen may be recommended at the surgical glue fixation site.

• Brand Name: BIOGLUE SURGICAL ADHESIVE
• Type of Device: GLUE,SURGICAL,ARTERIES
• Manufacturer (Section D): CRYOLIFE, INC. ¿ KENNESAW; 1655 roberts blvd. nw; kennesaw GA 30155
• MDR Report Key: 8358741
• MDR Text Key: 136786944
• Report Number: 1063481-2019-00007
• Device Sequence Number: 1
• Product Code: MUQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/05/2019

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 Operator: No Information
• Device Model Number: BG3510-5-J
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/05/2019
• Initial Date Manufacturer Received: 02/05/2019
• Initial Date FDA Received: 02/21/2019
• Supplement Dates Manufacturer Received: 02/05/2019
• Supplement Dates FDA Received: 07/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 42 YR