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

Model Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Aortic Dissection (2491); Pericardial Effusion (3271)

Event Date 08/15/2017

Event Type  Death  

Manufacturer Narrative

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

Event Description

According to initial reports, patient expired (b)(6) 2017.A hospital representative communicated the following: patient had fragile x syndrome, multisystem organ failure, oxygen levels dropped, dnr.Date of death was (b)(6) 2017.The hospital representative was unable to provide cause of death.Multiple attempts have been made for cause of death, however all attempts have gone unmet.According to operative notes: preoperative diagnosis: dissection of the ascending aorta with a pericardia effusion postoperative diagnosis: dissection of the ascending aorta with extension into the right main coronary artery with mild aortic regurgitation and bloody pericardial effusion operation/procedure: bentall reconstruction of the aortic root and ascending aorta using a 23 mm on-x composite graft to reconstruct the aorta with reimplantation of the left main coronary artery, oversewing of the right main coronary artery with bypass from the graft to the right main coronary artery using a length of reverse autogenous saphenous vein graft from the left groin, reconstructing the ascending aorta with a 28 mm hemashield graft using moderately profound hypothermic total cardiopulmonary bypass and arrest with arterial cannulation of the right subclavian artery and venous cannulation of the right femoral and superior vena cava using intermittent cold blood retrograde cardioplegia for cardiac arrest anesthesia: general endotracheal anesthesia complications: none apparent at the completion of the procedure findings: as anticipated, the patient had dissection of the ascending aorta.Upon opening the aorta, the dissection appeared clean; that is, there was no obvious reentry point.The dissection seemed to be limited to the distal ascending and proximal arch.It did not appear grossly to involve the takeoffs of the cervical vessels.The right main coronary was dissected, and the intima completely came out of the artery when trying to reconstruct the button.The artery was oversewn and bypassed individually with a length of saphenous vein.At the completion of the procedure, contractility was preserved.There was about a 200-300 ml pericardial effusion when we opened the chest.There was no bleeding to explain this upon opening the chest, and no bleeding from the myocardium per se around the annulus as we came off pump.Poppets on the valve, which was a mechanical valve, appeared to work nicely.Summary of use of bioglue: the intima was attached to the adventitia, placing felt inside and outside of the aortic wall and in between the medial and adventitial layers, suturing these triple layer felt in place with a running 3-0 prolene suture.The 28 mm graft was then brought into the field, tailored to fit, and end-to-end was performed with a running 3-0 suture there as well.The anastomosis was sealed with bioglue.The retrograde catheter was removed from the right atrium, and it was closed with a running 5-0 prolene suture.The two ends of the graft were tailored to fit and closed with a running 4-0 prolene suture.The vent was removed from the left atrial appendage and stapled with an echelon stapler.It was sealed with bioglue.The anastomosis of the left coronary button and the area around the valve was sealed with bioglue.The graft anastomosis was sealed with bioglue.A defect was made in the ascending aorta graft, the proximal end of the vein graft tailored to fit, and using running 5-0 prolene suture, end-to-side anastomosis was performed.

Manufacturer Narrative

The device history records were reviewed and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.As a date of implant was provided but a lot number of bioglue used was not provided, shipping records were queried for lots of bioglue shipped to the hospital in the 6-months prior to the date of implant.The search returned the following batch numbers: 17mut002, 17mut004, and 17mut006.One non-conformance was issued; however, it was determined to be unrelated to the reported events.A review of the available information was performed.The (b)(6) male preoperative diagnosis was dissection of ascending aorta with a pericardial effusion.On (b)(6) 2017 the patient underwent a ¿bentall reconstruction of the aortic root and ascending aorta using a 23 mm on-x composite graft to reconstruct the aorta with reimplantation of the left main coronary artery, oversewing of the right main coronary artery with bypass from the graft to the right main coronary artery using a length of reverse autogenous saphenous vein graft from the left groin, reconstructing the ascending aorta with a 28 mm hemashield graft.¿ the operative notes also states, ¿the two ends of the graft were tailored to fit and closed with a running 4-0 prolene suture.The vent was removed from the left atrial appendage and stapled with an echelon stapler.It was sealed with bioglue.The anastomosis of the left coronary button and the area around the valve was sealed with bioglue.The graft anastomosis was sealed with bioglue." additional information indicated that the patient expired on (b)(6) 2017; information is unavailable regarding the official cause of death.Hospital reported the patient had, ¿fragile x syndrome, multisystem organ failure, oxygen levels dropped.Patient had dnr.¿ no additional information is available.It is unclear based on the available information the sequence of events preceding the patient¿s death.Based on the information given by the hospital of ¿multisystem organ failure¿ there is no information which would attribute the patient¿s death to bioglue.Death is a potential adverse event related to cardiac and vascular procedures.In 1998 cryolife began a clinical trial investigating the use of bioglue as an adjunct in the surgical repair of acute, stanford type a aortic dissections.A total of 175 patients were enrolled in this study.This included 54 non-randomized (lead-in) patients, 60 patients randomized to standard surgery plus bioglue, and 61 patients randomized to standard surgery only.An interim analysis was performed after the 100th patient was enrolled into the randomized portion of the trial and had completed the 30-day follow-up period.There was no statistically significant difference in early mortality between the two groups (bioglue summary of safety and effectiveness).A prospective randomized control trial between bioglue and standard surgical repair for anastamotic sealing showed no difference in rates of death between the bioglue and control groups (coselli et al.2003).Based on the information provided by the hospital it is likely that the patient¿s death was due to multisystem organ failure (unknown cause) and subsequent respiratory failure.There is not enough information to determine what, if any, relationship the death of the patient had to do with bioglue.No further action required.

Event Description

According to initial reports, patient expired (b)(6) 2017.A hospital representative communicated the following: patient had fragile x syndrome, multisystem organ failure, oxygen levels dropped, dnr.Date of death was (b)(6) 2017.The hospital representative was unable to provide cause of death.Multiple attempts have been made for cause of death, however all attempts have gone unmet.According to operative notes: preoperative diagnosis: 1.Dissection of the ascending aorta with a pericardia effusion postoperative diagnosis: 1.Dissection of the ascending aorta with extension into the right main coronary artery with mild aortic regurgitation and bloody pericardial effusion operation/procedure: 1.Bentall reconstruction of the aortic root and ascending aorta using a 23 mm on-x composite graft to reconstruct the aorta with reimplantation of the left main coronary artery, oversewing of the right main coronary artery with bypass from the graft to the right main coronary artery using a length of reverse autogenous saphenous vein graft from the left groin, reconstructing the ascending aorta with a 28 mm hemashield graft using moderately profound hypothermic total cardiopulmonary bypass and arrest with arterial cannulation of the right subclavian artery and venous cannulation of the right femoral and superior vena cava using intermittent cold blood retrograde cardioplegia for cardiac arrest anesthesia: general endotracheal anesthesia complications: none apparent at the completion of the procedure findings: as anticipated, the patient had dissection of the ascending aorta.Upon opening the aorta, the dissection appeared clean; that is, there was no obvious reentry point.The dissection seemed to be limited to the distal ascending and proximal arch.It did not appear grossly to involve the takeoffs of the cervical vessels.The right main coronary was dissected, and the intima completely came out of the artery when trying to reconstruct the button.The artery was oversewn and bypassed individually with a length of saphenous vein.At the completion of the procedure, contractility was preserved.There was about a 200-300 ml pericardial effusion when we opened the chest.There was no bleeding to explain this upon opening the chest, and no bleeding from the myocardium per se around the annulus as we came off pump.Poppets on the valve, which was a mechanical valve, appeared to work nicely.Summary of use of bioglue: the intima was attached to the adventitia, placing felt inside and outside of the aortic wall and in between the medial and adventitial layers, suturing these triple layer felt in place with a running 3-0 prolene suture.The 28 mm graft was then brought into the field, tailored to fit, and end-to-end was performed with a running 3-0 suture there as well.The anastomosis was sealed with bioglue.The retrograde catheter was removed from the right atrium, and it was closed with a running 5-0 prolene suture.The two ends of the graft were tailored to fit and closed with a running 4-0 prolene suture.The vent was removed from the left atrial appendage and stapled with an echelon stapler.It was sealed with bioglue.The anastomosis of the left coronary button and the area around the valve was sealed with bioglue.The graft anastomosis was sealed with bioglue.A defect was made in the ascending aorta graft, the proximal end of the vein graft tailored to fit, and using running 5-0 prolene suture, end-to-side anastomosis was performed.

• Brand Name: BIOGLUE SURGICAL ADHESIVE
• Type of Device: GLUE, SURGICAL ADHESIVE
• Manufacturer (Section D): CRYOLIFE, INC.; 1655 roberts blvd. nw; kennesaw GA 30144
• Manufacturer (Section G): CRYOLIFE, INC.; 1655 roberts blvd; kennesaw GA 30144
• Manufacturer Contact: rochelle maney ; 1655 roberts blvd., nw; kennesaw, GA 30144
• MDR Report Key: 7379718
• MDR Text Key: 103771666
• Report Number: 1063481-2018-00010
• Device Sequence Number: 1
• Product Code: MUQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/08/2018
• Date Manufacturer Received: 03/08/2018
• 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): Death
• Patient Age: 40 YR