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

Model Number BG UNK

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

Patient Problems Granuloma (1876); Inflammation (1932)

Event Type  Injury  

Event Description

According to publication, ¿can surgical adhesives may cause false positivity in follow-up positron emission tomography after lung cancer resection?¿, 6 patients who underwent pulmonary resection between jan 2015 and dec 2018 for nsclc had false positives of recurrence at the bronchial stump in follow-up fdg pet-ct due to foreign body reactions.Bioglue was applied to the staple line during all 6 procedures.Each patient exhibited granuloma or chronic inflammation at the stump, with 4 of the 6 patients cases confirmed through histopathologic examination.The other 2 patients were followed for 3 months, and their condition subsequently improved.Authors conclude to avoid unnecessary biopsies or surgical procedures, false-positives due to surgical adhesives should be considered while interpreting follow-up fdg-pet imaging results.The authors also state that even though 5cc of bioglue was applied it is difficult to conclude with this limited data whether the amount of glue has an impact on the false positivity.

Event Description

According to publication, ¿can surgical adhesives may cause false positivity in follow-up positron emission tomography after lung cancer resection?¿, 6 patients who underwent pulmonary resection between (b)(6) 2015 and (b)(6) 2018 for nsclc had false positives of recurrence at the bronchial stump in follow-up fdg pet-ct due to foreign body reactions.Bioglue was applied to the staple line during all 6 procedures.Each patient exhibited granuloma or chronic inflammation at the stump, with 4 of the 6 patients cases confirmed through histopathologic examination.The other 2 patients were followed for 3 months, and their condition subsequently improved.Authors conclude to avoid unnecessary biopsies or surgical procedures, false-positives due to surgical adhesives should be considered while interpreting follow-up fdg-pet imaging results.The authors also state that even though 5cc of bioglue was applied it is difficult to conclude with this limited data whether the amount of glue has an impact on the false positivity.

• 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: 11886032
• MDR Text Key: 254045793
• Report Number: 1063481-2021-00019
• 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
• Type of Report: Initial,Followup
• Report Date: 07/30/2021

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
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 04/28/2021
• Initial Date Manufacturer Received: 04/28/2021
• Initial Date FDA Received: 05/26/2021
• Supplement Dates Manufacturer Received: 04/28/2021
• Supplement Dates FDA Received: 07/30/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other