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 Pneumonia (2011); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Death  

Event Description

Per the article combining minimally invasive techniques in managing a frail patient with postpneumonectomy bronchopleural fistula (kostopanagiotou k et al, 2021) a 79-year-old, female patient with chronic ppbpf arrived at emergency room with severe dysponea and cyanosis.First intervention, 10 ml bioglue used which immediately stopped air leak.20 days later the stump reopened, and the air leak reappeared.Sutures used to close opening with 10 ml bioglue and a cellulose mesh applied to the site.Bioglue used in the previous procedure was dislodged and removed.The stump failed again after 4 months and surgery was scheduled.However, the patient died at home from pneumonia before the procedure.The authors state that the combination of single nylon suture, bioglue, and [cellulose mesh] effectively controlled the air leak however a highly unlikely permanent measure.

Event Description

Per the article ¿combining minimally invasive techniques in managing a frail patient with postpneumonectomy bronchopleural fistula¿ (kostopanagiotou k et al, 2021) a 79-year-old, female patient with chronic ppbpf arrived at emergency room with severe dysponea and cyanosis.First intervention, 10 ml bioglue used which immediately stopped air leak.20 days later the stump reopened, and the air leak reappeared.Sutures used to close opening with 10 ml bioglue and a cellulose mesh applied to the site.Bioglue used in the previous procedure was dislodged and removed.The stump failed again after 4 months and surgery was scheduled.However, the patient died at home from pneumonia before the procedure.The authors state that the combination of single nylon suture, bioglue, and [cellulose mesh] effectively controlled the air leak however a highly unlikely permanent measure.

• 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: 12381564
• MDR Text Key: 268689635
• Report Number: 1063481-2021-00027
• 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: 11/02/2021

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: 07/30/2021
• Initial Date Manufacturer Received: 07/30/2021
• Initial Date FDA Received: 08/29/2021
• Supplement Dates Manufacturer Received: 07/30/2021
• Supplement Dates FDA Received: 11/02/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 79 YR