MAUDE Adverse Event Report: CRYOLIFE, INC. ¿ KENNESAW BIOGLUE SURGICAL ADHESIVE; GLUE,SURGICAL,ARTERIES

Model Number UNKNOWN

Device Problem Insufficient Information (3190)

Patient Problems HIV, Human Immunodeficiency Virus (2197); Chronic Obstructive Pulmonary Disease (COPD) (2237); Reaction (2414)

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 reports, surgeon commented adverse reaction possibly due to use of bioglue.A male, (b)(6) years old, copd, (b)(6), upper third lobectomy, right lung.Strong inflammatory reaction maintained in the suture area (in parenchyma), preventing sealing of the air leak.Sometime around 2017/2018.3 to 5 cc.With rigid cannula.Aerial leak, reoperated at 19/21 days by minithoracotomy, the field is observed directly.The intervention took place at christmas 2017, surgical intervention took place after the holidays (about two weeks or so).Surgeon remembered "the tissue at the scarred edges of the distal area (on which he had applied bioglue), presented signs of inflammation, observed the edge of the mechanical suture, applied previously with a manual suture (polypropylene monofilament), to approximate the edges.Again used bioglue as sealant (about 3cc), after a few minutes of drying, proceeded to make a test sealing (vasalva), resulting satisfactory; after a few days of observation, patient was discharged from hospital.

Event Description

According to reports, surgeon commented adverse reaction possibly due to use of bioglue.A male, 57 years old, copd, hiv +, upper third lobectomy, right lung.Strong inflammatory reaction maintained in the suture area (in parenchyma), preventing sealing of the air leak.Sometime around 2017/2018.3 to 5 cc.With rigid cannula.Aerial leak, reoperated at 19/21 days by minithoracotomy, the field is observed directly.The intervention took place at christmas 2017, surgical intervention took place after the holidays (about two weeks or so).Surgeon remembered "the tissue at the scarred edges of the distal area (on which he had applied bioglue), presented signs of inflammation, observed the edge of the mechanical suture, applied previously with a manual suture (polypropylene monofilament), to approximate the edges.Again used bioglue as sealant (about 3cc), after a few minutes of drying, proceeded to make a test sealing (vasalva), resulting satisfactory; after a few days of observation, patient was discharged from hospital.

Manufacturer Narrative

Correction to patient identifier: (b)(6).A review of the available information was performed.An adverse event was reported a surgeon participating in the post market follow-up survey.Per the survey answers, the surgeon used bioglue for pulmonary procedures approximately 2-3 times a month last year with pulmonary resection being the most common procedure.Additional information was received from the physician regarding this event: ¿male, 57 years old, copd, hiv +, upper third lobectomy, right lung, strong inflammatory reaction maintained in the suture area (in parenchyma), preventing sealing of the air leak, 2017/2018 (i do not have a reliable record), 3 to 5 cc.With rigid cannula, when the leak does not stop, it is re-operated at 19/21 days by mini thoracotomy and the field is observed directly, aerial leak, no, just that episode¿.The event was not reported to cryolife.Further information was received from surgeon: the intervention was on christmas 2017, and the reoperation took place after the holidays (about 2 weeks or so).Per his recollection, ¿the tissue at the scarred edges of the distal area (on which he had applied bg), presented signs of inflammation, proceeding to review the edge of the mechanical suture, applied previously, with a manual suture (polypropylene monofilament), to approximate the edges¿.He again used bioglue (about 3cc), and after a few minutes of drying, proceeded to make a test sealing (vasalva) with satisfactory results.The patient was discharged from the hospital after a few days of observation without any further issue.Based on the additional information provided by the surgeon, it cannot be determined what may have caused the inflammatory reaction.The patient has chronic obstructive pulmonary disease (copd) which is an inflammatory lung disease that results in obstructed airflow within the lungs.Furthermore, an inflammatory response to an opportunistic infection related to the patient¿s hiv status remains a possibility.Additionally, although the amount of bioglue that the surgeon has stated to have used during the procedure is not excessive, a foreign body type inflammatory response cannot be excluded.The absence of clinical signs of an inflammatory response following the second application of bioglue indicates that the initial reaction was unlikely to be an antibody mediated, or other bioglue specific, immune response.A bioglue specific inflammatory reaction would be expected to recur with subsequent exposure.Based on the available information from the case report, the root cause of the event cannot be determined.However, a bioglue specific immune response is unlikely.A non-specific foreign body type inflammatory reaction cannot be excluded.Foreign-body type inflammatory reactions are known complications of bioglue use.Adequate precautions and warnings are provided in the instructions for use.No further action required at this time.This report is being submitted as required by federal regulations and does not constitute an admission that the device caused or contributed to the reported event.Furthermore, this report reflects the event as alleged by the complainant and does not imply that the information reported to cryolife is accurate or has been confirmed by cryolife.

• Brand Name: BIOGLUE SURGICAL ADHESIVE
• Type of Device: GLUE,SURGICAL,ARTERIES
• Manufacturer (Section D): CRYOLIFE, INC. ¿ KENNESAW; 1655 roberts blvd. nw; kennesaw GA 30144
• MDR Report Key: 8434584
• MDR Text Key: 139290820
• Report Number: 1063481-2019-00012
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/13/2019
• Initial Date Manufacturer Received: 03/13/2019
• Initial Date FDA Received: 03/19/2019
• Supplement Dates Manufacturer Received: 03/13/2019
• Supplement Dates FDA Received: 03/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 57 YR