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

Model Number BG3510-5-J

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

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, in approximately (b)(6) 2012, bioglue was used for the hemiarch aorta replacement surgery for acute aortic dissection.It was applied to the proximal false lumen and the proximal suture line.Fifteen months after the first case ((b)(6) 2014), it was found that the recanalization had occurred at the proximal suture line and the patient underwent the re-hemiarch aorta replacement surgery.During the second surgery, it was found that bioglue had remained directly at the back of the proximal false lumen.The patient recovered and was discharged from the hospital.Bioglue was used with great caution such as priming and protection with wet gauze.The application site was an adequately dry condition.

Manufacturer Narrative

According to the report, in approximately (b)(6) 2012, bioglue was used for the hemiarch aorta replacement surgery for acute aortic dissection.It was applied to the proximal false lumen and the proximal suture line.Fifteen months after the first case ((b)(6) 2014), it was found that the recanalization had occurred at the proximal suture line and the patient underwent the re-hemiarch aorta replacement surgery.During the second surgery, it was found that bioglue had remained directly at the back of the proximal false lumen.The patient recovered and was discharged from the hospital.Bioglue was used with great caution such as priming and protection with wet gauze.The application site was an adequately dry condition.Information was received from (b)(4), the manufacturer of record for bioglue in (b)(4), that this event was erroneously twice-reported by the surgeon.The event was previously investigated as the event in 1063481-2013-00029.

Event Description

According to the report, in approximately (b)(6) 2012, bioglue was used for the hemiarch aorta replacement surgery for acute aortic dissection.It was applied to the proximal false lumen and the proximal suture line.Fifteen months after the first case ((b)(6) 2014), it was found that the recanalization had occurred at the proximal suture line and the patient underwent the re-hemiarch aorta replacement surgery.During the second surgery, it was found that bioglue had remained directly at the back of the proximal false lumen.The patient recovered and was discharged from the hospital.Bioglue was used with great caution such as priming and protection with wet gauze.The application site was an adequately dry condition.

• 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: 3658707
• MDR Text Key: 18708041
• Report Number: 1063481-2014-00005
• 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,User Facility,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2014
• 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: 02/27/2014
• 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