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

Model Number BG3510-5-J

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

Patient Problems Death (1802); Aortic Dissection (2491); 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 initial report the patient had an aortic dissection.Bioglue was used to false lumen proximal end.The condition/integrity of the native tissue is unknown.Post operatively a pseudoaneurysm was confirmed on the false lumen proximal end close to rcc (right coronary cusp).(b)(6) operation followed as intervention.After the reoperation, endocarditis infective was confirmed; however patient refused to receive another operation.Patient's outcome: death.It is supposed from the doctor's experience in using bioglue that the appropriate amount was applied, the field was kept dry, and there was no problem in the actual use of the product.It is unknown if bioglue was used as an adjunct to sutures and if the vessel was clamped and depressurized prior to application of bioglue.Additional information according to the doctor, the tissue of the vessels was rather fragile for this patient.Causal relationship to the device is unknown, but cannot be completely denied either.

Event Description

According to the initial report the patient had an aortic dissection.Bioglue was used to false lumen proximal end.The condition/integrity of the native tissue is unknown.Post operatively a pseudoaneurysm was confirmed on the false lumen proximal end close to rcc (right coronary cusp).David operation followed as intervention.After the reoperation, endocarditis infective was confirmed; however patient refused to receive another operation.Patient's outcome: death.It is supposed from the doctor's experience in using bioglue that the appropriate amount was applied, the field was kept dry, and there was no problem in the actual use of the product.It is unknown if bioglue was used as an adjunct to sutures and if the vessel was clamped and depressurized prior to application of bioglue.Additional information according to the doctor, the tissue of the vessels was rather fragile for this patient.Causal relationship to the device is unknown, but cannot be completely denied either.

Manufacturer Narrative

A review of the available information was performed.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 anastaomsis and from the chemical reaction to the aldehyde contained in the glue material (bingley, ja et al).¿ given the additional information from the doctor, bioglue was applied to tissue that ¿was rather fragile¿, and this raises 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.Furthermore, while surgical glue is helpful in surgery for acute type a aortic dissection, it may also cause late psuedoaneurysm 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 patients (fehrenbacher 2006).Weiner et al.Presented at the 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 pseudoaneurysn 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 no evidence to indicate an association between the use of bioglue and the pseudoanuerysm formed.Pseudoaneurysm formation is a known complication in standard surgical repair.The possible application of bioglue to the extremely fragile tissue raises the question of whether attempted salvage of the native aorta was the correct surgical decision.Additionally, as bioglue is terminally sterilized through a validated process it is unlikely that bioglue contributed to the reported endocarditis.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.; kennesaw GA 30144
• MDR Report Key: 8539279
• MDR Text Key: 142731027
• Report Number: 1063481-2019-00022
• 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: 06/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: BG3510-5-J
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NO INFORMATION; NO INFORMATION; NO INFORMATION
• Patient Outcome(s): Death; Hospitalization; Life Threatening; Required Intervention