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 Problem Abscess (1690)

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 initial report received via email on 12/11/2019, a presentation in (b)(6) reported a (b)(6) male that required emergency ascending and hemi-arch aortic replacement for acute type a dissection.The anastomotic suture line was reinforced by application of bioglue.On post operative day 7 the patient developed fever, cough and dypnea treatment was broad spectrum antibiotics for suspected pneumonia.Persistent fever and inflammatory syndrome resulted in a chest ct on post operative day 11.The chest ct showed a suspicious perigraft fluid graft collection.Re-operation was performed where the drainage of a whitish milky liquid.The area was lavaged (irrigated) using a mechanical water jet.All remnants of bioglue were removed.The patient became rapidly apyrteic and normalization of inflammatory markers.The recovery was uneventful without fever or any inflammatory response.Histopathologic analysis and dedicated staining showed fibrin-inflammatory reaction without signs of micro-organisms.The broad spectrum microbial cultures were negative.

Manufacturer Narrative

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 2001).When used properly, histopathological observations with bioglue are consistent with a normal foreign body reaction.Coselli et al.Found 2.6% of bioglue patients developed inflammatory, immune systemic allergic reaction (coselli 2003).The exact amount of bioglue used is unknown; however, if a large amount was utilized it could result in an enhanced or prolonged inflammatory reaction.Fever is a non-specific response to inflammation commonly seen after surgical procedures.Possible causes of post-operative fever are numerous and virtually impossible to attribute to any specific source.A fever as result of a foreign body inflammatory response related to the use of bioglue cannot be excluded.Per the case report, it is unkown whether the patient had any allergies or sensitivities to glutaraldeyde or bovine products.Allergic reaction, inflammatory and immune response are listed as potential complications in the ifu.Based on the available information provided in the case report, we are unable to definitively determine the cause of the events observed.However, fever and foreign-body inflammatory response related to the use of bioglue cannot be excluded.There is no indication following research to date that a perigraft seroma following cardiac procedures, especially aortic, have been caused by bioglue.Allergic reaction, inflammatory and immune response to bioglue are known possible complications and adequate precautions and warning are present in the ifu.No further action required.The risk file was reviewed.Risk analysis of the reported event has determined the risk of sensitization is adequately addressed.There is insufficient information to determine if there is an association between the use of bioglue and the events reported.Fever and foreign-body inflammatory response related to the use of bioglue cannot be excluded.There is no indication following research to date that perigraft seroma following cardiac procedures, especially aortic, have been caused by bioglue.Allergic reaction, and inflammatory and immune response to bioglue are known possible complications and adequate precautions and warnings are present in the ifu.No further action is required.Each individual hazard is mitigated and reduced as low as possible by design and process.Post-production residual risk is communicated in the product's labeling and ifu (instructions for use).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.

Event Description

According to the initial report received via email on 12/11/2019, a presentation in geneva reported a 54 year old male that required emergency ascending and hemi-arch aortic replacement for acute type a dissection.The anastomotic suture line was reinforced by application of bioglue.On post operative day 7 the patient developed fever, cough and dypnea treatment was broad spectrum antibiotics for suspected pneumonia.Persistent fever and inflammatory syndrome resulted in a chest ct on post operative day 11.The chest ct showed a suspicious perigraft fluid graft collection.Re-operation was performed where the drainage of a whitish milky liquid.The area was lavaged (irrigated) using a mechanical water jet.All remnants of bioglue were removed.The patient became rapidly apyrteic and normalization of inflammatory markers.The recovery was uneventful without fever or any inflammatory response.Histopathologic analysis and dedicated staining showed fibrin-inflammatory reaction without signs of micro-organisms.The broad spectrum microbial cultures were negative.

• 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: 9459395
• MDR Text Key: 185931256
• Report Number: 1063481-2019-00076
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 01/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2019
• 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
• Date Manufacturer Received: 12/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ANTIBIOTICS ON POST OPERATIVE DAY 7
• Patient Outcome(s): Hospitalization
• Patient Age: 54 YR