MAUDE Adverse Event Report: CRYOLIFE, INC. BIOGLUE SYRINGE 5-PACK, 10 ML, JAPAN; GLUE,SURGICAL,ARTERIES

Model Number BG3510-5-J

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

Patient Problems Fistula (1862); Hypoxia (1918); Necrosis (1971); Pseudoaneurysm (2605)

Event Date 04/04/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the initial report, "proximal anastomotic pseudoaneurysm and right pulmonary artery fistula were confirmed 5 months after the initial operation in a patient who underwent total arch replacement using bioglue for acute type a dissection.Pathological examination of the pseudoaneurysm revealed tissue necrosis"."aortic root reconstruction surgery (modified bentall procedure), surgical closure of right pulmonary artery aneurysm were performed.After the surgery, oxygenation decreased in the lungs, ventilator weaning took a long time and rehabilitation was conducted for the disuse syndrome during that period".

Event Description

According to the initial report, "proximal anastomotic pseudoaneurysm and right pulmonary artery fistula were confirmed 5 months after the initial operation in a patient who underwent total arch replacement using bioglue for acute type a dissection.Pathological examination of the pseudoaneurysm revealed tissue necrosis." "aortic root reconstruction surgery (modified bentall procedure), surgical closure of right pulmonary artery aneurysm were performed.After the surgery, oxygenation decreased in the lungs, ventilator weaning took a long time and rehabilitation was conducted for the disuse syndrome during that period.".

Manufacturer Narrative

A definitive lot number could not be obtained, however the following lot numbers were shipped to this hospital from 2015 to nov 2016: 14mjx020, 14mjx033, 15mjx004, 15mjx007, 15mjx017, 15mjx014, 15mjx016, 15mjx018, 15mjx023, 16mjx001, 16mjx003, 16mjx005, and 16mjx007.The manufacturing records for all lots 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.According to the initial report, a proximal anastomotic pseudoaneurysm and right pulmonary artery fistula were confirmed five months after the initial operation in which the patient underwent total arch replacement due to an acute type a dissection.Bioglue was used during that operation.An aortic root reconstruction surgery using the modified bentall procedure was then performed and surgical closure of the right pulmonary artery aneurysm.Following the re-operation, ¿oxygenation decreased in the lungs, ventilator weaning took a long time, and rehabilitation was conducted for the disuse syndrome during that period.¿ the pathological examination of the pseudoaneurysm revealed tissue necrosis.The following is unknown: the amount of bioglue used in the initial operation, whether bioglue syringe was primed/deaired properly, and if bioglue was applied at the site where the pseudoaneurysm was found.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, la et al).¿ if bioglue was applied to extremely fragile tissue, this would raise the question of whether attempted salvage of the native aorta was an appropriate surgical decision.Perhaps the native tissue was too damaged to be repaired and an aortic replacement with a synthetic graft should have been considered for this case.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 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, the control group, without bioglue use, had similar incidences of pseudoaneurysm formation (weiner 2010).There is no definitive correlation between the use of bioglue and pseudoaneurysm formation.Pseudoaneurysm formation is a known complication in standard aortic dissection surgical repair.The possible application of bioglue to extremely fragile tissue raises the question whether attempted salvage of the native aorta was the correct surgical decision.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 SYRINGE 5-PACK, 10 ML, JAPAN
• Type of Device: GLUE,SURGICAL,ARTERIES
• Manufacturer (Section D): CRYOLIFE, INC.; 1655 roberts blvd., nw; kennesaw GA 30144
• MDR Report Key: 8552245
• MDR Text Key: 143220655
• Report Number: 1063481-2019-00023
• 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: 07/26/2019

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: Health Professional
• Device Model Number: BG3510-5-J
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/09/2019
• Initial Date Manufacturer Received: 04/09/2019
• Initial Date FDA Received: 04/25/2019
• Supplement Dates Manufacturer Received: 04/09/2019
• Supplement Dates FDA Received: 07/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other