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

Model Number BG UNK

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

Patient Problems Inflammation (1932); Pseudoaneurysm (2605); Valvular Stenosis (2697)

Event Type  Injury  

Event Description

According to the publication titled: complications of bioglue post surgery for aortic dissections and aortic valve replacement by a.Luk et al details four cases of bioglue use found at redo surgery, after the formation of pseudoaneurysm and aortic stenosis.Additional information from the publication detailed four cases of excised aortic tissue and/or aortic valves with previous bioglue use at initial operation.All specimens were excised at the second surgery, and sent for pathological examination.The presence of bioglue and inflammatory cells were evaluated.Four patients underwent redo surgery for ascending aortic arch repair and/or coronary artery bypass surgery.Three patients original surgeries were for type i aortic dissection while one patient had aortic valve replacement (avr) due to bicuspid aortic valve.Redo surgery was required due to pseudoaneurysm formation in three patients, and one of these patients also had aortic insufficiency.One patient presented with syncope and aortic stenosis.Serial echocardiograms or ct scans detected pseudoaneurysms, aortic insufficiency and severe aortic stenosis.Three patients underwent aortic root replacement alone, and one a bentall procedure.All patients were discharged.One patient who had repair of a persistent aortic root aneurysm with ai had evidence of bioglue found within the false lumen, and no inflammatory reaction found directly around the bioglue.Two patients, both with repair of type 1 aortic dissection, had islands of inflammatory infiltrates in the aortic tissue, as well as surrounding areas of bioglue.One patient with persistent as underwent redo valve replacement where there were large annular abscesses filled with necrotic debris surrounding the prosthesis and pannus at the sewing cuff.With in vitro and in vivo experiments, it has been proposed that the polymerized bioglue can still release glutaraldehyde that has shown to cause cytotoxic effects to neighboring tissue including aortic tissue by inducing inflammation, edema formation and necrosis at the site of application.This is the likely cause of pseudoaneurysm formation in two of the patients.Following manufacturer's instructions may prevent the complications of pseudoaneurysm.We believe the inflammatory reaction to bioglue may have contributed to pseudoaneurysm and sterile abscess formation.The judicious use of bioglue and close follow-up of patients is an integral part of avoiding complications.

Event Description

According to the publication titled: complications of bioglue post surgery for aortic dissections and aortic valve replacement by a.Luk et al details four cases of bioglue use found at redo surgery, after the formation of psuedoaneurysm and aortic stenosis.Additional information from the publication detailed four cases of excised aortic tissue and/or aortic valves with previous bioglue use at initial operation.All specimens were excised at the second surgery, and sent for pathological examination.The presence of bioglue and inflammatory cells were evaluated.Four patients underwent redo surgery for ascending aortic arch repair and/or coronary artery bypass surgery.Three patients original surgeries were for type i aortic dissection while one patient had aortic valve replacement (avr) due to bicuspid aortic valve.Redo surgery was required due to pseudoaneurysm formation in three patients, and one of these patients also had aortic insufficiency.One patient presented with syncope and aortic stenosis.Serial echocardiograms or ct scans detected psuedoaneurysms, aortic insufficiency and severe aortic stenosis.Three patients underwent aortic root replacement alone, and one a bentall procedure.All patients were discharged.One patient who had repair of a persistent aortic root aneurysm with ai had evidence of bioglue found within the false lumen, and no inflammatory reaction found directly around the bioglue.Two patients, both with repair of type 1 aortic dissection, had islands of inflammatory infiltrates in the aortic tissue, as well as surrounding areas of bioglue.One patient with persistent as underwent redo valve replacement where there were large annular abscesses filled with necrotic debris surrounding the prosthesis and pannus at the sewing cuff.With in vitro and in vivo experiments, it has been proposed that the polymerized bioglue can still release glutaraldehyde that has shown to cause cytotoxic effects to neighboring tissue including aortic tissue by inducing inflammation, edema formation and necrosis at the site of application.This is the likely cause of pseudoaneurysm formation in two of the patients.Following manufacturer's instructions may prevent the complications of pseudoaneurysm.We believe the inflammatory reaction to bioglue may have contributed to pseudoaneurysm and sterile abscess formation.The judicious use of bioglue and close follow-up of patients is an integral part of avoiding complications.

• Brand Name: BIOGLUE-UNKNOWN CONFIGURATION
• Type of Device: GLUE, SURGICAL, ARTERIES
• Manufacturer (Section D): CRYOLIFE, INC.; 1655 roberts blvd. nw; kennesaw GA 30144
• MDR Report Key: 12259244
• MDR Text Key: 264500465
• Report Number: 1063481-2021-00024
• Device Sequence Number: 1
• Product Code: MUQ
• Combination Product (y/n): N
• PMA/PMN Number: P010003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: BG UNK
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/28/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other