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

Model Number BG UNK

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

Patient Problem 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.This report is being submitted as required by 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

Per journal article ¿cutaneous-pericardial fistula: rare complication of transapical aortic valve replacement-case report and literature review" a (b)(6) patient with severe aortic stenosis underwent tavr via the ta approach.Bioglue was used "for complete hemostasis due to persistent mild bleeding".6 months after discharge the patient returned "complaining about left chest pain and chronic draining sinus localized on the left thoracotomy scar".Ct showed "hour-glass"-shape fistula connecting heart's apex and chest wall, with "small apical collection (13mm) with adjacent inflammatory infiltration involving pledget sutures".The aseptic abscess included residual depots of bioglue and pledget sutures.Cavity was drained and wound closed.No recurrence observed 12 months from discharge."cutaneous-pericardial fistula is a rare complication of ta-tavr, which can be preceded by an extensive array of both intrinsic (obesity, diabetes, and copd) and extrinsic (bio-glue usage) risk factors.The surgical approach is a treatment of choice for cutaneous-pericardial fistula with good postoperative results."".

Event Description

The author of the article, answered the following questions and provided additional feedback: date of original surgery? (b)(6) 2018 (trans-apical tavi).Date of surgical intervention? (b)(6) 2019 (pericardial fistula excision).Product code and lot number of bioglue used? unfortunately, i wasn't able to identify the product code and lot number, the label of the product is glued to the patient chart and the entire paper archive was evacuated from the main hospital building because of fire.I found out that we don't have this information in the digital archive.I will still try to find this information for you but maybe it will take more time.Amount of bioglue applied on the site? [surgeon], who performed the procedure mentioned that he applied approximately 2 to 3 ml of bioglue.Was the target field dry at the time of application? after ligation of the pledget sutures and administration of protamine, the bleeding from the insertion site on the apex of the heart stopped not as fast as usual.We used bioglue as an additional precaution after this delay in hemostasis but the operation field was dry already.Was the bioglue allowed to polymerize for a full two minutes? the bioglue had more than 2 minutes to polymerize.Was bioglue previously used in the patient? the patient underwent in 2005 cabg procedure but at that moment the bioglue was not used, at least it is not mentioned in the existing records.Are you a frequent user of bioglue? we use bioglue in all cases of acute aortic dissection and in some cases of free wall cardiac ruptures, i can say that the department has a good experience in bioglue usage but in transapical tavi it was used for the first time.On behalf of [surgeon], i want to tell that he associates this unpleasant complication with the comorbidities of the patient, his poor physical status, and complicated post-operative period.Regarding bioglue, maybe it played a role but definitely less important.

Manufacturer Narrative

Clinical/medical reviewed the available information.Per the article, the patient had a medical history of obesity, arterial hypertension, diabetes, prior coronary artery bypass grafting, and reduced left ventricular ejection fraction (35%).The authors conclude that "cutaneous-pericardial fistula is a rare complication of ta-tavr, which can be preceded by an extensive array of both intrinsic (obesity, diabetes, and copd) and extrinsic (bio-glue usage) risk factors.The surgical approach is a treatment of choice for cutaneous-pericardial fistula with good postoperative results." per the surgeon¿s statement, while bioglue may have played a ¿less important¿ role in the observed events, the complications were mainly due to ¿the comorbidities of the patient, his poor physical status, and complicated post-operative period¿.The department has had a ¿good experience¿ with using bioglue for acute aortic dissection cases as well as some cases of free wall cardiac ruptures.Based on the available information provided in the case report, the observed events per the surgeon¿s statement were primarily a result of the patient¿s comorbidities and poor health however a reaction to bioglue cannot be ignored.While the surgeon could not confirm if bioglue contributed to the observed events, the surgeon believes it did not play a major role.Should additional information become available, it will be reviewed and a need for investigation will be determined then.Risk management reviewed the available information.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.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 will continue to be monitored for trends.Based on the available information provided in the case report, the observed events per the surgeon¿s statement were primarily a result of the patient¿s comorbidities and poor health.However, a reaction to bioglue cannot be ignored.While the surgeon could not confirm if bioglue contribute to the observed events, the surgeon believes it did not play a major role.The root cause of this event cannot be established as there is no evidence to suggest that bioglue contributed to the reported adverse event within the publication; however, a potential cause could be patient sensitivity.There is no indication that an error or deficiency occurred at cryolife and all risks identified have been mitigated as far as possible and residual risk is acceptable.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.

• Brand Name: BIOGLUE - UNKNOWN CONFIGURATION
• Type of Device: GLUE,SURGICAL,ARTERIES
• Manufacturer (Section D): CRYOLIFE, INC. - KENNESAW; 1655 roberts blvd. nw; kennesaw GA 30144
• MDR Report Key: 10773582
• MDR Text Key: 216837330
• Report Number: 1063481-2020-00028
• 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: 01/06/2021

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/27/2020
• Initial Date FDA Received: 11/02/2020
• Supplement Dates Manufacturer Received: 10/27/2020
• Supplement Dates FDA Received: 01/06/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other