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 Problem 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

According to the initial report, "doctor used bioglue for aortic root replacement and formation of false aneurysm was confirmed as a postoperative outcome on the distal suture line.Patient's been recovered.Doctor does not think bioglue is attributable to false aneurysm.Distributor has made multiple attempt to gain additional information, but no further information has been obtained.Bioglue was applied to both proximal end of false lumen as well as proximal and distal suture lines.As postoperative outcome.Formation of false aneurysm has been reported on the distal suture line and re-operation followed.Date of surgery is unknown.".

Manufacturer Narrative

Cryolife was given surgeon's names as additional information received by the distributor.The initial contact information will not be updated as the information was provided to cryolife via the distributor.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 initial report, "doctor used bioglue for aortic root replacement and formation of false aneurysm was confirmed as a postoperative outcome on the distal suture line.Patient's been recovered.Doctor does not think bioglue is attributable to false aneurysm.Distributor has made multiple attempt to gain additional information, but no further information has been obtained.Bioglue was applied to both proximal end of false lumen as well as proximal and distal suture lines.As postoperative outcome.Formation of false aneurysm has been reported on the distal suture line and re-operation followed.Date of surgery is unknown." according to the distributor, "specific date of first surgery is unknown, but it took place in year 2017.".

Manufacturer Narrative

A review of manufacturing records could not be performed as lot numbers are unknown.Additionally, a query could not be performed for potential lot numbers shipped to the hospital prior to implant as date of implant is unknown.A review of the available information was performed.During an aortic root replacement for acute type a aortic dissection, bioglue was applied to the proximal end of the false lumen, proximal suture line, and distal suture line.Exact date of original surgery is unknown however we do know it was in 2017.An unspecified amount of time later, a false aneurysm was reported on the distal suture line.The patient underwent a re-operation.  doctor does not think bioglue attributed to false lumen.Information surrounding the initial operation, pseudoaneurysm formation, and reoperation is unknown; in particular the following information: the time between the initial operation and the false aneurysm, if bioglue was properly de-aired and primed, and amount of bioglue applied.Pseudoaneurysm formation is a known complication in standard surgical repair.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 (b)(6) 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).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) the root cause of the reported event is unknown however the surgeon did not attribute the pseudoaneurysm formation to bioglue.The ifu lists anastomotic pseudoaneurysm as a potential complication associated with the use of bioglue.

• 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: 7127735
• MDR Text Key: 95178074
• Report Number: 1063481-2017-00046
• 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,health pr
• Type of Report: Initial,Followup,Followup
• Report Date: 03/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: BG3510-5-J
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/04/2017
• Date Manufacturer Received: 12/04/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other