MAUDE Adverse Event Report: CRYOLIFE. INC BIOGLUE - UNKNOWN CONFIGURATION; GLUE,SURGICAL,ARTERIES

Model Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Tissue Damage (2104)

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 an email received on (b)(6) 2017, "(b)(6) woman underwent an aortic valve replacement and graft replacement of ascending aorta where bioglue was used.Three (3) months later the patient had an abrupt onset of chest pain.Ct [computed tomography] revealed results which suggested a mpa tear.Re-operation was performed to fix the mpa [main pulmonary artery] tear.During the operation it was noted that the tissue around the tear site was soft, friable, and brownish foreign material was densely adhered to the vessel.The brownish material was identified as bioglue.The authors state that some amount of the bioglue that had been applied to the aortic root spread to the neighboring pulmonary artery and seemingly induced an inflammatory reaction.".

Manufacturer Narrative

Multiple attempts made to obtain additional information to no avail.A review was performed with the available information.Woo et al published a case report ¿delayed pulmonary artery rupture after using bioglue in cardiac surgery.¿ the case report details a (b)(6) woman who underwent an aortic valve replacement and graft replacement of ascending aorta due to severe aortic regurgitation with an ascending aortic aneurysm.Three months later the woman went to the er (emergency room) with abrupt onset of chest pain.The original operation took place at a separate hospital then the admission to the er and subsequent reoperation.A contrast enhanced ct (computed tomography) revealed extravasation of dye from the mpa (main pulmonary artery), suggestion rupture of the mpa and a 77-mm hematoma around the ascending aorta.A re-operation was performed to repair the artery and to evacuate the hematoma.During surgery a 1.5cm longitudinal tear was identified on the mpa.The tissue around the site was soft and friable and brownish foreign material was densely adhered and the neighboring tissue was firm and did not show inflammation or necrotic changes.The necrotic mpa tissue was resected and repaired.The patient was discharged with no further complication.The authors speculate, ¿the adhered material (hematioma with bioglue) between the aortic conduit and mpa was thought to have caused direct pressure on the necrotic portion of the mpa.Consequently, repetitive pressure on the necrotic mpa seemed to induce mpa tearing.¿ information surrounding this adverse event is unknown.The following information is unknown: amount of bioglue applied during the initial surgery, if actions were taken to protect non-target areas from bioglue, and where bioglue was applied.Foreign body reactions have been reported with the use of bioglue.Hewitt et al.Performed an animal study where bioglue was applied to a sheep¿s aorta; histopathologically, bioglue generate only a minimal inflammatory response (hewitt et al 2011).When used properly, histopathological observations with bioglue are consistent with a normal foreign body reaction.Based on the severity of the reaction it can be concluded that a large amount bioglue was used.It is possible that the large amounts of bioglue utilized in this patient resulted in an enhanced or prolonged inflammatory reaction.Additionally, a large quantity of bioglue could produce a mass lesion which compressed and damaged adjacent structures such as the mpa.It should also be noted that the case report references the 2001 kazui et al paper.In the paper grf or bioglue was used and there were 4 cases (7%) of redissection; however, only 1 of the 4 cases was bioglue used or 1.75%.Also the histopathological findings, that were called out in the case report, the original article specifically states that it was at the site of grf glue application (kazui et al 2001).In the bioglue ifu (instructions for use) it warns ¿bioglue should be applied in a thin layer as an adjunct to sutures or staples, and in amounts sufficient to seal the area.Bioglue should not be applied in excess.¿ also it states, ¿apply an even coating of bioglue to target area.In general use an approximately 1.0-3.0 mm thick coating for vessels greater than 2.5 cm in diameter¿¿the ifu lists observed adverse events ¿bioglue applied to non-targeted tissue¿ and ¿inflammatory reaction.¿ there is insufficient information to determine the precise cause of the mpa tear; however, the misuse of bioglue could have been a contributing factor.Since the original was on the aorta, there is no apparent reason for bioglue to have been applied to the mpa.Therefore, it appears that the original surgeon failed to follow the instructions for use by applying too much bioglue and failing to protect adjacent anatomic structures.An inflammatory reaction cannot be excluded however there are adequate precautions and warning provided in the ifu (instructions for use.

Event Description

According to an email received on 12/18/2017, "(b)(6) woman underwent an aortic valve replacement and graft replacement of ascending aorta where bioglue was used.3 months later the patient had an abrupt onset of chest pain.Ct [computed tomography] revealed results which suggested a mpa tear.Re-operation was performed to fix the mpa [main pulmonary artery] tear.During the operation it was noted that the tissue around the tear site was soft, friable, and brownish foreign material was densely adhered to the vessel.The brownish material was identified as bioglue.The authors state that some amount of the bioglue that had been applied to the aortic root spread to the neighboring pulmonary artery and seemingly induced an inflammatory reaction.".

• Brand Name: BIOGLUE - UNKNOWN CONFIGURATION
• Type of Device: GLUE,SURGICAL,ARTERIES
• Manufacturer (Section D): CRYOLIFE. INC; 1655 roberts blvd. nw; kennesaw GA 30144
• MDR Report Key: 7195936
• MDR Text Key: 97398219
• Report Number: 1063481-2018-00001
• 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: foreign,study
• Type of Report: Initial,Followup
• Report Date: 03/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/18/2017
• Date Manufacturer Received: 12/18/2017
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening
• Patient Age: 56 YR