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

Model Number BG3510-5-J

Device Problem Insufficient Information (3190)

Patient Problem Aneurysm (1708)

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 report, a hemiarch aorta replacement surgery was conducted for acute stanford type a aortic dissection one year ago and bioglue was used.The false aneurysm occurred one year after the surgery and re-operation was conducted.

Manufacturer Narrative

According to the report, a hemiarch aorta replacement surgery was conducted for acute stanford type a aortic dissection one year ago and bioglue was used.The false aneurysm occurred one year after the surgery and re-operation was conducted.Additional information was received which stated the patient was a (b)(6) female.Bioglue was applied to the proximal false lumen and the proximal and distal suture lines.When the computed tomography (ct) scan was performed after the first surgery, approximately 8cm false aneurysm was found in ascending aorta and emergency surgery was performed.When the lesion was confirmed in the re-operation, blood was found oozing from the sinus of valsalva of the non-coronary cusp.The sinus of valsalva was repaired with a synthetic graft.The results of the pathology examination were not available.The surgeon's view was that the cause of the event would not be identified even through the pathology results as the sample sent to pathology was of the blood vessel wall around the pseudoaneurysm and not of the pseudoaneurysm itself.Bioglue was used with great caution such as priming.The exact lot number of bioglue was unknown; cmi was unable to determine possible lot numbers from shipping records as the date of the initial procedure could not be determined.Therefore, a review of the manufacturing records could not be performed.The surgeon (name unknown) commented that the site where the false aneurysm occurred seemed to be affected by tissue toxicity of glutaraldehyde.The delivery device-mediated application is designed to provide reproducible mixing of the components in-vitro.The bioglue instructions for use contains warnings to ensure that bioglue is properly mixed prior to making contact with tissue.Further, based on the clinical safety profile and historic complaint data, there is no evidence to suggest that glutaraldehyde in bioglue contributes to tissue damage.A review was performed on the known complaint information.Pseudoaneurysm is a known potential complication to aortic dissection repair regardless of the procedure or devices used.Based on the information available at the time of the report, a definitive cause of the false aneurysm observed in this patient could not be determined.

Event Description

According to the report, a hemiarch aorta replacement surgery was conducted for acute stanford type a aortic dissection one year ago and bioglue was used.The false aneurysm occurred one year after the surgery and re-operation was conducted.

• Brand Name: BIOGLUE SURGICAL ADHESIVE
• Type of Device: SURGICAL ADHESIVE
• Manufacturer (Section D): CRYOLIFE, INC.; 1655 roberts blvd., nw; kennesaw GA 30144
• Manufacturer (Section G): CRYOLIFE, INC.; 1655 roberts blvd., nw; kennesaw GA 30144
• Manufacturer Contact: sandra o'reilly ; 1655 roberts blvd., nw; kennesaw, GA 30144 ; 7704193355
• MDR Report Key: 3673136
• MDR Text Key: 18709997
• Report Number: 1063481-2014-00006
• Device Sequence Number: 1
• Product Code: MUQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P010003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: BG3510-5-J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 74 YR