MAUDE Adverse Event Report: CRYOLIFE, INC. BIOGLUE SURGICAL ADHESIVE; GLUE,SURGICAL,ARTERIES

Model Number BG3510-5-J

Device Problem Insufficient Information (3190)

Patient Problems Fistula (1862); Pseudoaneurysm (2605)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2014, the patient underwent surgery for acute aortic dissection.On (b)(6) 2019 the patient required an ascending aorta replacement.A pseudoaneurysm was confirmed at the aortic root, and a fistula developed in the pulmonary artery adjacent to the aortic root.Blood flow was also confirmed between the aorta and the pulmonary artery due to the fistula.Bioglue was not visible from the previous surgery.Both the pseudoaneurysm and fistula were confirmed at the site where bioglue was previously applied.It looked like blood flowed from the fistula going into the false lumen led to the development of pseudoaneurysm.The patient has recovered and been discharged.

Manufacturer Narrative

A review of the available information was performed.According to the report, on (b)(6) 2014, a patient underwent surgery for acute aortic dissection (bioglue was applied to the false lumen and suture line).On (b)(6) 2019, pseudoaneurysm was confirmed at the aortic root, and fistula developed in the pulmonary artery adjacent to the aortic root.Blood flow was also confirmed between the aorta and the pulmonary artery due to the fistula.The surgeon reported that something formed a mass, but couldn¿t specify what it was.¿ furthermore, ¿the patient required an ascending aorta replacement in (b)(6) 2019.Bioglue was not visible and the mass was not identified to be bioglue by the doctor.The patient has recovered and been discharged.The physician's opinion: both the pseudoaneurysm and fistula were confirmed at the site where bioglue was previously applied.It looked like blood flowed from the fistula going into the false lumen led to the development of pseudoaneurysm; however, doctor has given comment it is unclear if the events are directly related to the use of bioglue.¿ the following information is unknown: the condition of the native tissue before surgery, how much bioglue was used in the procedure, or if the syringe was primed and de-aired.The nature of the ¿mass¿ noted by the surgeon remains unknown.The development of an aorto-pulmonary fistula suggests either a mechanical or inflammatory process that eroded the media of both vessels.The absence of identifiable bioglue at reoperation neither implicates nor excludes bioglue as a contributory factor in the reported event.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 for acute type a aortic 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 97consecutive patients in whom bioglue was used to reinforce thoracic aortic suture lines.During follow-up 2 patients were identified as having a pseudoaneurysm, the control group, without bioglue use, had similar incidences of 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).There is insufficient information to determine if there is an association between the use of bioglue and the pseudoaneurysm and fistula formed.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.No further action recommended.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 SURGICAL ADHESIVE
• Type of Device: GLUE,SURGICAL,ARTERIES
• Manufacturer (Section D): CRYOLIFE, INC.; 1655 roberts blvd. nw; kennesaw GA 30144
• MDR Report Key: 8870181
• MDR Text Key: 153560990
• Report Number: 1063481-2019-00047
• 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: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 09/10/2019

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: BG3510-5-J
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/25/2019
• Initial Date Manufacturer Received: 07/25/2019
• Initial Date FDA Received: 08/07/2019
• Supplement Dates Manufacturer Received: 07/25/2019
• Supplement Dates FDA Received: 09/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention