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

Device Problems Device Operates Differently Than Expected (2913); Positioning Problem (3009)

Patient Problem Regurgitation (2259)

Event Type  Injury  

Event Description

According to the emailed report, the surgeon said that bioglue has been behaving differently than he expected.He had a re-operation for regurgitation a few weeks ago where he found bioglue on the leaflets.Once it was removed, the patient's regurgitation issue stopped and he believes bioglue was the cause for the re-operation.He said the bioglue does not seem as thick and he feels it is going through the suture holes (which he never found before).

Manufacturer Narrative

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

Manufacturer Narrative

According to the emailed report, the surgeon said that bioglue has been behaving differently than he expected.He had a re-operation for regurgitation a few weeks ago where he found bioglue on the leaflets.Once it was removed, the patient's regurgitation issue stopped and he believes bioglue was the cause for the re-operation.He said the bioglue does not seem as thick and he feels it is going through the suture holes (which he never found before).Additional information was requested from the surgeon regarding the initial procedure, details on how bioglue was used and stored, and timeline of events, among other information; however, the surgeon contacted the cryolife representative and stated that he would not respond to any request for information and would not be giving additional details of the event.Manufacturing records for possible lot numbers were reviewed and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.Based on the information available at the time of this report, the cause of the regurgitation observed in this patient or the bioglue found on the valve leaflets upon reoperation could not definitively be determined.The surgeon has stated that he is not sure if the syringe was primed prior to patient application.It is important that bioglue is applied to a well-constructed suture line; however, the condition of the tissue or the anastomosis is unknown.It is unknown if de-airing (air space removal) and priming were performed, which are necessary to ensure that bioglue that is completely mixed in the correct ratio of bsa to glutaraldehyde is dispensed.It is also unknown if there was negative pressure present (i.E., left ventricular [lv] vent on) during bioglue application which could cause bioglue to be pulled into the true lumen through the suture holes and/or through a gap in the suture line.In addition, the surgeon stated that he was not sure if the staff had properly primed the syringe.This statement implies that the surgeon did not personally prime the syringe immediately prior to use.Improper priming may lead to inconsistent viscosity of the bioglue during application.There have been no recent changes in the bioglue formulation.Adequate precautions and warnings regarding the use of an lv vent and product priming are provided in the instructions for use.

Event Description

According to the emailed report, the surgeon said that bioglue has been behaving differently than he expected.He had a re-operation for regurgitation a few weeks ago where he found bioglue on the leaflets.Once it was removed, the patient's regurgitation issue stopped and he believes bioglue was the cause for the re-operation.He said the bioglue does not seem as thick and he feels it is going through the suture holes (which he never found before).

• 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: 4055949
• MDR Text Key: 15364209
• Report Number: 1063481-2014-00038
• Device Sequence Number: 1
• Product Code: MUQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2014
• 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