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 Problem Cyst(s) (1800)

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 cryolife is accurate or has been confirmed by cryolife.

Event Description

According to the publication titled: aseptic mediastinal cyst caused by bioglue 7 months after cardiac surgery by a.Szfranek reported a (b)(6) year old male who underwent coronary artery bypass grafting and removal of thrombus from the apex of the left ventricle was readmitted to the hospital 7 months after the original operation complaining of a cystic swelling of sudden onset in the lower part of the sternotomy scar.The ultrasonographic report was suggestive of false aneurysmal dilatation of one of the intercostal arteries, and chest computed tomographic scanning was performed for the venous and arterial phase, which showed that there was a collection in the anterior mediastinum.All radiologic features were suggestive of an abscess.Microbiological analysis of the gray color fluid removed by needle aspiration was without bacterial growth.The fluid contained predominantly polymorphic leucocytes.Thoracoscopic exploration was performed after the cyst became full and tender again.Thick creamy fluid was drained from the subcutaneous cyst.Partial resection of the xiphoid allowed for the insertion of a 5mm telescope into the retrosternal cavity which contained clear fluid and a dark, hard irregular mass of artificial material.This mass was removed.A third chest ct scan was performed 1 month after the second operation, which showed complete absence of the mediastinal collection.Bioglue was used to reinforce the suture line of the left apical ventriculotomy before going off of bypass.The patient had an uneventful recovery and was discharged home on the 7th postoperative day.When the patient returned 7 months after the operation with a probable abscess over the lower sternal incision, we were confident that the patient would require debridement because of the mediastinitis.Having performed microbiologic and radiologic diagnostics.We decided to explore the cyst with the least invasive technique.A thoracoscopic technique allowed us to drain the cyst, and we found a foreign body within the cavity.There are a variety of responses to bioglue; a few authors describe massive foreign-body inflammation response in the surroundings of the glue, with histiocytes and granulocytes full of glue remnant.From recently published articles describing histologic reaction to glue, it is still not clear whether this response has any adverse effect on patients.This patient had to be exposed to surgical intervention again, and fortunately, his symptoms were limited to only pain and discomfort.Dr.(b)(6) replied "this publication is at least 10 years old i am sorry but i don't think i can assist you with answers to your questions.".

Manufacturer Narrative

The amount of bioglue used during the procedure is unknown.In the bioglue ifu it warns ¿bioglue should be applied in a thin layer as an adjunct to sutures or staples, and in amounts sufficient to seal area.Bioglue should not be applied in excess.¿ inflammatory reaction is listed as an observed and potential adverse event in the ifu as well.Foreign body reactions have been reported with the use of bioglue.Hewitt et al.Performed an animal study where bioglue was applied to a sheep¿s aorta; histopathologically, bioglue generate only a minimal inflammatory response (hewitt et al 2001).When used properly, histopathological observations with bioglue are consistent with a normal foreign body reaction.Coselli et al.Found 2.6% of bioglue patients developed inflammatory, immune systemic allergic reaction (coselli 2003).The exact amount of bioglue used is unknown; however, if a large amount was utilized it could result in an enhanced or prolonged inflammatory reaction.Per the article, in tissues with cells having less collagen and elastin, a massive inflammation and fluid collection can be a reactive response (furst w, banerjee a.).However, that reaction seems to be dependent on the individual.The authors of the publication conclude that ¿in some cases glue might help to avoid longer operation time, blood product transfusion, and complications related to bleeding; however, it should be limited to cases in which it is absolutely indicated.¿ the description of the cystic lesion, cytologic findings, and remnants of bioglue are consistent with a sterile abscess, likely resulting from a foreign-body type inflammatory response to bioglue.Allergic reaction, inflammatory and immune response to bioglue are known possible complications and adequate precautions and warning are present in the ifu.Risk performed a review of the available information.The bioglue a/dfmea was reviewed.The reported event is addressed in step/id # 3, 4, 5, 9, 13, 15, 47, 49, 63, 64, 65, 66, 134, 135, 136, 137, 142, and 143.The reported event could not be confirmed.No sample was returned, and the lot number is unknown.A potential cause of the event is patient sensitivity and/or foreign body reaction.The amount of bioglue used during the procedure is unknown.In the bioglue ifu it warns ¿bioglue should be applied in a thin layer as an adjunct to sutures or staples, and in amounts sufficient to seal the area.Bioglue should not be applied in excess¿.Inflammatory reaction is listed as an observed and potential adverse event in the ifu as well.No new risks were identified during the course of the risk management departmental complaint investigation.All risks identified have been mitigated as far as possible and residual risk is acceptable.Complaints and clinical publications will continue to be monitored for trends.

Event Description

According to the publication titled: aseptic mediastinal cyst caused by bioglue 7 months after cardiac surgery by (b)(6) reported a 66 year old male who underwent coronary artery bypass grafting and removal of thrombus from the apex of the left ventricle was readmitted to the hospital 7 months after the original operation complaining of a cystic swelling of sudden onset in the lower part of the sternotomy scar.The ultrasonographic report was suggestive of false aneurysmal dilatation of one of the intercostal arteries, and chest computed tomographic scanning was performed for the venous and arterial phase, which showed that there was a collection in the anterior mediastinum.All radiologic features were suggestive of an abscess.Microbiological analysis of the gray color fluid removed by needle aspiration was without bacterial growth.The fluid contained predominantly polymorphic leucocytes.Thoracoscopic exploration was performed after the cyst became full and tender again.Thick creamy fluid was drained from the subcutaneous cyst.Partial resection of the xiphoid allowed for the insertion of a 5mm telescope into the retrosternal cavity which contained clear fluid and a dark, hard irregular mass of artificial material.This mass was removed.A third chest ct scan was performed 1 month after the second operation, which showed complete absence of the mediastinal collection.Bioglue was used to reinforce the suture line of the left apical ventriculotomy before going off of bypass.The patient had an uneventful recovery and was discharged home on the 7th postoperative day.When the patient returned 7 months after the operation with a probable abscess over the lower sternal incision, we were confident that the patient would require debridement because of the mediastinitis.Having performed microbiologic and radiologic diagnostics.We decided to explore the cyst with the least invasive technique.A thoracoscopic technique allowed us to drain the cyst, and we found a foreign body within the cavity.There are a variety of responses to bioglue; a few authors describe massive foreign-body inflammation response in the surroundings of the glue, with histiocytes and granulocytes full of glue remnant.From recently published articles describing histologic reaction to glue, it is still not clear whether this response has any adverse effect on patients.This patient had to be exposed to surgical intervention again, and fortunately, his symptoms were limited to only pain and discomfort.Dr.(b)(6) replied "this publication is at least 10 years old i am sorry but i don't think i can assist you with answers to your questions.".

• 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: 10815503
• MDR Text Key: 215469056
• Report Number: 1063481-2020-00032
• 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: company representative,litera
• Type of Report: Initial,Followup
• Report Date: 01/13/2021

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: BG UNK
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/03/2020
• Initial Date FDA Received: 11/10/2020
• Supplement Dates Manufacturer Received: 11/03/2020
• Supplement Dates FDA Received: 01/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention