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

Model Number BG3510-5-J

Device Problem Material Fragmentation (1261)

Patient Problems Embolus (1830); Ischemia (1942)

Event Type  Injury  

Event Description

According to the report, a bentall procedure and total arch replacement were performed on a patient with acute aortic dissection in (b)(6) 2013.The bioglue was applied on proximal and distal false lumen and distal suture lines.The patient had symptoms of ischemia in lower limb in middle of (b)(6) 2013.When a lower limb artery thrombectomy was performed at the end of 2013, a piece of bioglue was found.The embolus was pathologically equivalent to bioglue.

Manufacturer Narrative

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

Manufacturer Narrative

According to the report, a bentall procedure and total arch replacement were performed on a patient with acute aortic dissection in (b)(6) 2013.The bioglue was applied on proximal and distal false lumen and distal suture lines.The patient had symptoms of ischemia in lower limb in middle of (b)(6) 2013.When a lower limb artery thrombectomy was performed at the end of 2013, a piece of bioglue was found.The embolus was pathologically equivalent to bioglue.The patient was recently discharged from the hospital.It is the surgeon's view that the "bioglue used for the distal suture line flew to lower limb in a few months later." the amount of applied bioglue was two pieces.One piece was used in the proximal and distal false lumen.The other piece was used on the proximal and distal suture lines.Bioglue was used with great caution such as priming and protecting with wet gauze.The lv vent was turned off during bioglue application.The surgeon considers that a part of the bioglue which was applied to the false lumen of the distal side peeled off and then went into the bloodstream from re-entry and because of that the patient had lower limb embolism.It is uncertain but the surgeon thinks that re-entry area was between distal side of arch aorta and distal aorta.Bioglue was used adequately and the site was protected with gauze in accordance with the ifu.A review of possible lot numbers was performed and it was confirmed that all records were controlled, available for review, and met all specifications per the device master record.A review of available information was performed.The information received suggests that bioglue applied to the distal false lumen of the aortic dissection may have migrated and entered the systemic circulation at a re-entry point in the abdominal aorta.This is possible if the false lumen was not fully cleaned of any thrombus/debris and/or if bioglue was not applied to a temporary dry field.If bioglue was applied to a properly prepared field, the covalent bonds created between the bioglue and the tissue would be too strong for bioglue peel away from the tissue.This is a known potential complication of bioglue use in aortic dissection.Precautions are included in the instructions for use (ifu) to take actions to prevent re-entry of bioglue.Examples of such actions include use of a balloon catheter or gauze to define the distal limit of bioglue application.It does not appear that a balloon catheter was used in this case.

Event Description

According to the report, a bentall procedure and total arch replacement were performed on a patient with acute aortic dissection in (b)(6) 2013.The bioglue was applied on proximal and distal false lumen and distal suture lines.The patient had symptoms of ischemia in lower limb in middle of (b)(6) 2013.When a lower limb artery thrombectomy was performed at the end of 2013, a piece of bioglue was found.The embolus was pathologically equivalent to bioglue.

• 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: 3567443
• MDR Text Key: 4075890
• Report Number: 1063481-2014-00003
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2014
• 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: 01/07/2014
• 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