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

Model Number BG UNK

Device Problems Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Fistula (1862)

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 publication by marwah, v., et al.Titled ¿bronchoscopic device closure of postoperative bronchopleural fistulae: novel devices and innovative techniques.¿ lung india (2019) reported "retrospective analysis of 11 patients who underwent bronchoscopic device closure using various techniques to manage postoperative bronchopleural fistulae (bpf).Endobronchial coils with the use of bioglue to fill small gaps between coils was used for air leaks <4mm (n=5).The use of endobronchial coils with bioglue was successful in 3 of the 5 patients.The other 2 patients continued to be symptomatic after an additional application of bioglue.These patients underwent surgical stump closure." additional information patients 7, 8, 9, 10 and 11 all under went the bronchoscopic intervention with endobronchial coils followed by bioglue.Patient 7 is a (b)(6) year old female with bpf (bronchopleural fistulae) in the right lower lobe, size was 3.8 mm that was treated with a right lower lobectomy.The patient's primary disease and comorbidities were post tubercular bronchiectasis with hemoptysis.The patient presented with recurrence of symptoms indicating a failed closure so the stump was closed surgically.Patient 8 is a (b)(6) year old male with bpf (bronchopleural fistulae) in the left lower lobe, size was 2 mm that was treated with a left lower lobectomy.The patient's primary disease and comorbidities were cystic pulmonary hydatidosis.The patient had bioglue reinstalled after one year followed by successful bronchoscopic closure.Patient 10 is a (b)(6) year old female with bpf (bronchopleural fistulae) in the right upper lobe, size was 3.6 mm that was treated with a right upper lobectomy.The patient's primary disease and comorbidities were post tubercular sequelae with aspergilloma and hemoptysis.The patient presented with recurrence of symptoms indicating a failed closure so the stump was closed surgically.Patient 11 had successful bronchoscopic closure of bpf with endobronchial coils and bioglue.Bronchopleural fistula is an abnormal passageway (a sinus tract) that develops between the large airways in the lungs (the bronchi) and the space between the membranes that line the lungs (the pleural cavity).

Event Description

According to the publication by marwah, v., et al.Titled ¿bronchoscopic device closure of postoperative bronchopleural fistulae: novel devices and innovative techniques.¿ lung india (2019) reported "retrospective analysis of 11 patients who underwent bronchoscopic device closure using various techniques to manage postoperative bronchopleural fistulae (bpf).Endobronchial coils with the use of bioglue to fill small gaps between coils was used for air leaks <4mm (n=5).The use of endobronchial coils with bioglue was successful in 3 of the 5 patients.The other 2 patients continued to be symptomatic after an additional application of bioglue.These patients underwent surgical stump closure." additional information patients 7, 8, 9, 10 and 11 all under went the bronchoscopic intervention with endobronchial coils followed by bioglue.Patient 7 is a 42 year old female with bpf( bronchopleural fistulae) in the right lower lobe, size was 3.8 mm that was treated with a right lower lobectomy.The patient's primary disease and comorbidities were post tubercular bronchiectasis with hemopytsis.The patient presented with recurrence of symptoms indicating a failed closure so the stump was closed surgically.Patient 8 is a 33 year old male with bpf( bronchopleural fistulae) in the left lower lobe, size was 2 mm that was treated with a left lower lobectomy.The patient's primary disease and comorbidities were cystic pulmonary hydatidosis.The patient had bioglue reinstilled after one year followed by successful bronchoscopic closure.Patient 10 is a 52 year old female with bpf( bronchopleural fistulae) in the right upper lobe, size was 3.6 mm that was treated with a right upper lobectomy.The patient's primary disease and comorbidities were post tubercular sequale with aspergilloma and hemoptysis.The patient presented with recurrence of symptoms indicating a failed closure so the stump was closed surgically.Patient 11 had successful bronchoscopic closure of bpf with endobrachial coils and bioglue.Bronchopleural fistula is an abnormal passageway (a sinus tract) that develops between the large airways in the lungs (the bronchi) and the space between the membranes that line the lungs (the pleural cavity).

Manufacturer Narrative

Correction to a1 - 2020-2105 is correct information.The following is uknown: how much bioglue was used for each procedure, how it was ¿sprayed¿ through the the catheter, the condition of the tissue before application of bioglue, if bioglue was applied to a wet field, and whether bioglue was allowed to fully polymerize.Bioglue was never intended for application through a bronchoscope as performed in the study and was not used as an adjunct to sutures or staples as stated in the product ifu: ¿bioglue surgical adhesive is indicated for use as an adjunct to standard methods of surgical repair¿¿.The ifu also has the following warning, ¿do not use bioglue as a substitute for sutures or staples in tissue approximations.¿ the surgeon improvised an application method and procedure that has not been tested or approved.Bioglue has also not been tested for the use on the muscosal surface of the bronchi, nor along with the use of endobronchial coils.Based on the available information provided in the report, we are unable to definitively determine the cause of the events observed.The surgeon used bioglue outside of it¿s intended application, therefore it cannot be determined how it may function or react based on the procedure performed in the study.Since bioglue has not been tested using this method it is unkown what, if any, adverse events may occur.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 - UNKNOWN CONFIGURATION
• Type of Device: GLUE, SURGICAL, ARTERIES
• Manufacturer (Section D): CRYOLIFE INC.; 1655 roberts blvd.; kennesaw GA 30144
• MDR Report Key: 9585978
• MDR Text Key: 189497061
• Report Number: 1063481-2020-00078
• 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,literature,user facil
• Type of Report: Initial,Followup
• Report Date: 02/18/2020

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: BG UNK
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/03/2020
• Initial Date FDA Received: 01/14/2020
• Supplement Dates Manufacturer Received: 01/03/2020
• Supplement Dates FDA Received: 02/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening