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 Death (1802); Unspecified Infection (1930)

Event Type  Death  

Manufacturer Narrative

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

Event Description

Article, "bleeding control in type i aortic dissection" (authors tüysüz and gül) reports a retrospective study of 34 consecutive patients undergoing type 1 aortic dissection repair.Group 1: n = 20 no bioglue, median age: 63.Group 2: n = 14 bioglue, median age: 54.Dacron graft replaced aortic segment where dissection developed with bioglue being applied to anastomosis in group 2.Statistically significant difference in respiratory problems (group 1 = 0% vs group 2 = 21.4%), total mortality (group 1 = 40% vs group 2 = 7.1%), and mortality during surgery (group 1 = 30% vs group 2 = 0%).No significant difference in terms of bleeding severity, transfusion requirement, or need for reoperation.Authors mention that the reason for higher total mortality and intraoperative mortality may be associated with advancing age of group 1 where the degeneration in the aortic wall increases with age.Post-operative complications included: arrhythmia, respiratory problems, neurological problems, bleeding, infection, and mortality.".

Manufacturer Narrative

In the publication ¿bleeding in type i aortic dissection¿ (tuysuz and gul), a retrospective study was conducted of 34 consecutive patients undergoing type 1 aortic dissection repair.Group 1: n = 20 no bioglue, median age: 63.Group 2: n = 14 bioglue, median age: 54.Dacron graft replaced aortic segment where dissection developed with bioglue being applied to anastomosis in group 2.Statistically significant difference in respiratory problems (group 1 = 0% vs group 2 = 21.4%), total mortality (group 1 = 40% vs group 2 = 7.1%), and mortality during surgery (group 1 = 30% vs group 2 = 0%).No significant difference in terms of bleeding severity, transfusion requirement, or need for reoperation.Authors mention that the reason for higher total mortality and intraoperative mortality may be associated with advancing age of group 1 where the degeneration in the aortic wall increases with age.Post-operative complications included: arrhythmia, respiratory problems, neurological problems, bleeding, infection, and mortality.Additional information was received from the authors relayed via the distributor, "both dr.Gul and dr.Tuysuz repeatedly declared that they both are so pleased to use bioglue in every case.They are pleased to use bioglue in every case especially in risky cases tho, and they say they will continue to use bioglue." the manufacturing records were reviewed and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.All lots passed functional testing and met release specifications.There is no evidence in the publication which indicates what contribution, if any bioglue had to do with the post-operative complications.Per the publication, ¿both groups were evaluated in terms of bleeding severity, transfusion requirement, and the need for reoperation, no statistically significant difference was identified.¿ they conclude that bleeding could ¿result in heart failure, arrhythmia, infection, hemorrhagic shock and cardiac tamponade (yorganciogiu et al).¿ pulmonary complications were thought to be due to bleeding and the use of blood transfusions independently of the use of bioglue.While this publication states there is no significant difference in the bleeding severity between the use of bioglue and no bioglue, coselli et al (2003) reports on a prospective randomized control trial between bioglue and standard surgical repair for anastomotic sealing.The paper showed a statistically significant higher rate of successful intra-operative hemostasis with the use of bioglue when compared to the control group on both per patient and per anastomotic site basis.Reoperation for anastomotic site bleeding only occurred in 1 standard surgical repair patient.According to report, the doctors state there is no connection between bioglue and mortality in the study.They conclude that the mortality rates were increased due to other reasons, including that mortality in cardiovascular surgery increases with age.Furthermore, 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).There is no evidence to suggest that bioglue contributed to any of the reported adverse events within the publication.These reported events are common complications of aortic dissection surgery.They did not make any connection between mortality and the use of bioglue.The doctors state that they use bioglue and were ¿very pleased to use it in their cases.¿ a risk assessment was performed.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.This event does not identify additional hazards or modify the probability and severity of existing hazards.There is no indication that an error or deficiency occurred at cryolife and the ifu adequately communicates risk; therefore, corrective and preventive action is not warranted at this time.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.; 1655 roberts blvd. nw; kennesaw GA 30144
• MDR Report Key: 10077173
• MDR Text Key: 191657749
• Report Number: 1063481-2020-00004
• 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: 07/08/2020

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: 04/29/2020
• Initial Date FDA Received: 05/20/2020
• Supplement Dates Manufacturer Received: 04/29/2020
• Supplement Dates FDA Received: 07/08/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other