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

Model Number BG UNKNOWN

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

Patient Problems Aortic Regurgitation (1716); Arrhythmia (1721); Death (1802); Pseudoaneurysm (2605)

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 the journal article, ¿modified selective aortic root reconstruction with valve repair for treatment of stanford a aortic dissection" : retrospective observational study included 27 patients who had stanford type a aortic dissection involving the root and underwent modified selective root reconstruction with or without aortic valve repair.The study took place spanning from july 2014 until october 2019.Ptfe patch squeezed in the dissected sinuses, as far down into the root as possible.Before securing patch(es) in place with sutures, bioglue applied to both sides of the patch and both sides of patch.Valve repair then completed to nullify residual aortic regurgitation results: no operative mortality related to operation itself; however, 4 patients died during follow-up period (significant neurological disability, severe aortic regurgitation, pseudoaneurysm at suture line, sudden fatal arrhythmia).

Manufacturer Narrative

The following information was not provided and is unknown: the amount of bioglue applied and the condition of the native tissue during the repair.There is no evidence in the publication which indicates what contribution, if any, bioglue had to do with the post-operative complications.The authors conclude that the results of the modified selective root reconstruction with aortic valve repair technique are ¿excellent¿.They also state that the method is ¿quick, reliable, easily reproducible, and technically undemanding¿.They did not conclude or attribute any of the reported events to the use of bioglue.Per kitamura et al, pseudoaneurysm formation ¿is not a rare late complication late after repair of acute aortic dissection (mohammadi, s et al).The underlying mechanism of pseudoaneurysm formation is considered to be associated with tissue cutting due to the fragility of the dissected aortic wall at the anastomosis and from the chemical reaction to the aldehyde contained in the glue material (bingley, ja et al).¿ perhaps the native tissue was too damaged to be repaired and an aortic replacement with a synthetic graft should have been considered.Furthermore, while surgical glue is helpful in surgery with acute type a dissection, it may also cause late pseudoaneurysm formation or valve deterioration when not used properly (kitamura et al).Dr.Fehrenbacher et al.Performed a retrospective review of 92 consecutive patients who underwent complex operation in which bioglue was used.Postoperative pseudoaneurysm formation occurred in 3.3% of the patients (fehrenbacher 2006).Weiner et al.Presented at 15th world congress of heart disease in vancouver, canada in july 2010 they identified 97 consecutive patients in whom bioglue was used to reinforce thoracic aortic suture lines.During follow-up 2 patients were identified as having a pseudoaneurysm formation (weiner 2010).Ma et al.Reviewed 233 patients with a mean follow-up time of 2.4 years post-operation; a pseudoaneurysm was detected in only 1 patient (0.6%).The authors concluded, ¿the use of bioglue in thoracic aortic surgery was not associated with excess incidence of anastomotic pseudoaneurysm formation following surgical repair of thoracic aortic disease.¿ (ma 2017).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.There is also insufficient information to determine if there is any association between the use of bioglue and the pseudoaneurysms formed in the procedures.Pseudoaneurysm formation is a known complication in standard surgical repair of aortic dissections.The condition of the native aortic tissue at the time of initial surgery is unknown in this case.Pre-existing conditions such as aortic medial necrosis or other intrinsic aortic disease may have contributed to further complications.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 journal article, ¿modified selective aortic root reconstruction with valve repair for treatment of stanford a aortic dissection" : retrospective observational study included 27 patients who had stanford type a aortic dissection involving the root and underwent modified selective root reconstruction with or without aortic valve repair.The study took place spanning from july 2014 until october 2019.Ptfe patch squeezed in the dissected sinuses, as far down into the root as possible.Before securing patch(es) in place with sutures, bioglue applied to both sides of the patch and both sides of patch.Valve repair then completed to nullify residual aortic regurgitation results: no operative mortality related to operation itself; however, 4 patients died during follow-up period (significant neurological disability, severe aortic regurgitation, pseudoaneurysm at suture line, sudden fatal arrhythmia).

• 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: 10446279
• MDR Text Key: 204159435
• Report Number: 1063481-2020-00012
• 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: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model Number: BG UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/27/2020
• Initial Date Manufacturer Received: 07/27/2020
• Initial Date FDA Received: 08/24/2020
• Supplement Dates Manufacturer Received: 07/27/2020
• Supplement Dates FDA Received: 10/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other